This section highlights FDA-related milestones and regulatory updates for drugs developed by Eli Lilly and Company (LLY).
Over the past two years, Eli Lilly and Company has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
retatrutide, mirikizumab-mrkz, orforglipron, Pirtobrutinib, Taltz, EBGLYSS, and Baricitinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Retatrutide FDA Regulatory Timeline and Events
Retatrutide is a drug developed by Eli Lilly and Company for the following indication: in adults with obesity or overweight and knee osteoarthritis, and without diabetes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- retatrutide
- Announced Date:
- May 21, 2026
- Indication:
- in adults with obesity or overweight and knee osteoarthritis, and without diabetes
Announcement
Eli Lilly and Company announced positive topline results from TRIUMPH-1, a Phase 3 clinical trial evaluating the efficacy and safety of retatrutide, an investigational, first-in-class GIP, GLP-1, and glucagon triple hormone receptor agonist, in adults with obesity or overweight and at least one weight-related comorbidity and without diabetes.
AI Summary
Eli Lilly reported strong topline results from TRIUMPH-1, a Phase 3 study of retatrutide, an experimental triple-action drug for adults with obesity or overweight and at least one weight-related health problem, but without diabetes. At 80 weeks, people taking the 12 mg dose lost an average of 70.3 pounds, or 28.3% of their body weight. Nearly half of them, 45.3%, lost at least 30%, a weight loss level often linked to bariatric surgery. In a study extension, participants with a starting BMI of 35 or higher kept losing weight and reached an average loss of 85.0 pounds, or 30.3%, at 104 weeks. The 4 mg dose also performed well, with an average loss of 47.2 pounds, or 19.0%, and fewer discontinuations from side effects than placebo. Lilly said more results from its broader retatrutide program are expected over the next year.
Read Announcement- Drug:
- retatrutide
- Announced Date:
- March 19, 2026
- Indication:
- in adults with obesity or overweight and knee osteoarthritis, and without diabetes
Announcement
Eli Lilly and Company announced positive topline results from TRANSCEND-T2D-1, a Phase 3 clinical trial evaluating the efficacy and safety of retatrutide, an investigational first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, as an adjunct to diet and exercise.
AI Summary
Eli Lilly announced positive topline results from TRANSCEND-T2D-1, a Phase 3 trial of retatrutide, an investigational first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, tested as an adjunct to diet and exercise for adults with type 2 diabetes. The trial evaluated both efficacy and safety and reported results at 40 weeks.
For the primary endpoint, retatrutide lowered A1C by an average of 1.7% to 2.0% across doses at 40 weeks. Participants taking the 12 mg dose lost an average of 36.6 lbs (16.8%), and no weight-loss plateau was observed — weight loss continued through 40 weeks. The drug also showed meaningful improvements in non-HDL cholesterol, triglycerides, and systolic blood pressure.
TRANSCEND-T2D-1 is part of a global Phase 3 program that began in 2024 and has enrolled more than 2,050 participants across three registrational trials. Detailed results will be presented at the American Diabetes Association Scientific Sessions in June and submitted for peer-reviewed publication; additional trial data are expected over the next year.
Read Announcement- Drug:
- retatrutide
- Announced Date:
- December 11, 2025
- Indication:
- in adults with obesity or overweight and knee osteoarthritis, and without diabetes
Announcement
Eli Lilly and Company announced positive topline results from the Phase 3 TRIUMPH-4 clinical trial evaluating the safety and efficacy of the two highest investigational doses of retatrutide, a first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, in adults with obesity or overweight and knee osteoarthritis, and without diabetes, as an adjunct to healthy diet and physical activity.
AI Summary
Eli Lilly reported positive topline results from TRIUMPH-4, a Phase 3 trial testing the two highest doses of retatrutide (9 mg, 12 mg) in adults with obesity and knee osteoarthritis (no diabetes) as an adjunct to diet and exercise. At 68 weeks, the 12 mg dose achieved average weight loss of 28.7% (71 lbs) and the 9 mg dose 26.4%. Retatrutide cut WOMAC knee pain scores by up to 4.5 points (75.8%) and improved physical function. In a post-hoc analysis, more than one in eight treated patients were completely free of knee pain at week 68.
The trial also showed improvements in blood pressure, lipids and inflammation markers. Common side effects were GI (nausea, diarrhea, constipation, vomiting) and dysesthesia; discontinuations were higher than placebo. Lilly said seven additional Phase 3 trials in obesity and type 2 diabetes are expected to report in 2026.
Read Announcement
Mirikizumab-mrkz FDA Regulatory Timeline and Events
Mirikizumab-mrkz is a drug developed by Eli Lilly and Company for the following indication: For Crohn's disease.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- mirikizumab-mrkz
- Announced Date:
- May 5, 2026
- Indication:
- For Crohn's disease
Announcement
New long-term data from Eli Lilly and Company show patients with moderately to severely active ulcerative colitis (UC) treated with Omvoh (mirikizumab-mrkz) achieved durable disease clearance through four years of continuous treatment.
AI Summary
New four‑year data from Eli Lilly’s LUCENT‑3 study show that patients with moderately to severely active ulcerative colitis (UC) who continued treatment with Omvoh (mirikizumab‑mrkz) achieved durable disease clearance. Among patients who still remained in the study at year four, more than 60% of those who had reached disease clearance at one year maintained it through four years of continuous treatment. Using a conservative analysis that counts missing or discontinued patients as non‑responders, 49.7% maintained disease clearance and 42.8% maintained stringent disease clearance at year four.
Disease clearance is a high clinical bar that requires simultaneous symptomatic, endoscopic, and histologic remission. LUCENT‑3 was a single‑arm, open‑label extension that followed participants for up to four years to evaluate long‑term efficacy and safety after initial response in earlier LUCENT trials. The results suggest sustained deep remission with continued Omvoh treatment for many patients.
Read Announcement- Drug:
- mirikizumab-mrkz
- Announced Date:
- October 27, 2025
- Indication:
- For Crohn's disease
Announcement
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh (mirikizumab-mrkz) for subcutaneous use in adults with moderately to severely active ulcerative colitis (UC).
AI Summary
The U.S. Food and Drug Administration has approved a new maintenance regimen for Omvoh (mirikizumab-mrkz) in adults with moderate to severe ulcerative colitis. The regimen uses a single 200 mg/2 mL subcutaneous injection once a month, replacing the previous two-injection approach.
This simpler dosing option is designed to make treatment easier to manage alongside the daily challenges of living with ulcerative colitis. The new prefilled pen and prefilled syringe formats, which are citrate-free, will be available to U.S. patients in early 2026.
Approval was based on a Phase 1 study showing that one 200 mg injection is bioequivalent to two 100 mg injections. Patients begin therapy with three 300 mg IV infusions at four-week intervals before transitioning to the monthly subcutaneous dose.
With this approval, Omvoh offers adults a convenient way to maintain remission and support a better patient experience.
Read Announcement- Drug:
- mirikizumab-mrkz
- Announced Date:
- October 7, 2025
- Indication:
- For Crohn's disease
Announcement
New data from Eli Lilly and Company showed Omvoh (mirikizumab-mrkz) is the first and only interleukin-23p19 (IL-23p19) to help patients with moderately to severely active ulcerative colitis (UC) achieve sustained, long-term outcomes through four years.
AI Summary
New data from Eli Lilly and Company show that Omvoh (mirikizumab-mrkz) is the first and only interleukin-23p19 antagonist to deliver sustained, long-term control of moderately to severely active ulcerative colitis through four years. These final results from the Phase 3 LUCENT-3 open-label extension study demonstrate benefits across symptom relief, clinical measures, endoscopic healing, histology, and quality of life—even in patients who had previously failed advanced therapies.
Among patients who reached clinical remission at one year, 80% maintained long-term, corticosteroid-free clinical and endoscopic remission through four years. Nearly all reported improvements in bowel urgency, with 93% achieving at least a three-point reduction on the Urgency Numeric Rating Scale. Other key outcomes included 81% sustaining endoscopic remission, 66% achieving deep mucosal healing, and 90% reporting quality-of-life remission on the Inflammatory Bowel Disease Questionnaire.
The long-term safety profile was consistent with previous findings, with no new safety signals. These durable results highlight Omvoh’s potential to redefine comprehensive, steroid-free, long-term disease control in ulcerative colitis.
Read Announcement- Drug:
- mirikizumab-mrkz
- Announced Date:
- February 7, 2025
- Indication:
- For Crohn's disease
Announcement
Eli Lilly and Company announced results from the VIVID-2 open-label extension study, which showed the majority of patients with moderately to severely active Crohn's disease receiving two years of continuous treatment with Omvoh® (mirikizumab-mrkz) achieved long-term clinical and endoscopic outcomes, including those (43.8%) with previous biologic failure.
AI Summary
Eli Lilly recently announced promising results from the VIVID-2 open-label extension study of Omvoh® (mirikizumab-mrkz) for patients with moderately to severely active Crohn’s disease. Over two years of continuous treatment, the majority of patients experienced lasting clinical and endoscopic improvements. Notably, even among the 43.8% of patients who had previously experienced failure with other biologics, positive outcomes were observed. More than 90% of patients who were in clinical remission at one year continued to maintain their remission at two years, while nearly 90% also sustained the observed endoscopic healing. Omvoh works by targeting the interleukin-23p19 protein, which plays a key role in causing intestinal inflammation. These findings provide additional support for the long-term efficacy of Omvoh in managing Crohn’s disease and will be showcased at the upcoming Crohn’s and Colitis Congress.
Read Announcement- Drug:
- mirikizumab-mrkz
- Announced Date:
- January 15, 2025
- Indication:
- For Crohn's disease
Announcement
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease in adults.
AI Summary
Eli Lilly and Company announced that the FDA has approved Omvoh® (mirikizumab-mrkz) for adults with moderately to severely active Crohn’s disease. This approval is based on strong clinical data from the Phase 3 VIVID-1 trial, where patients treated with Omvoh showed significant improvements in clinical remission and visible healing of the intestines. Omvoh works by targeting a key protein, IL-23p19, which plays a major role in gut inflammation.
In the study, 53% of patients achieved clinical remission with Omvoh compared to 36% on placebo, and nearly half experienced a marked endoscopic response. Furthermore, long-term results revealed that almost 90% of patients maintained remission after two continuous years of treatment. This approval offers a promising new treatment option for adults facing the challenges of Crohn’s disease.
Read Announcement
Orforglipron FDA Regulatory Timeline and Events
Orforglipron is a drug developed by Eli Lilly and Company for the following indication: Orforglipron for the treatment of obesity and overweight.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- orforglipron
- Announced Date:
- April 16, 2026
- Indication:
- Orforglipron for the treatment of obesity and overweight
Announcement
Eli Lilly and Company announced positive topline results from the Phase 3 ACHIEVE-4 trial evaluating the efficacy and safety of Foundayo (orforglipron), compared to insulin glargine in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk. ACHIEVE-4, the largest and longest study of Foundayo in type 2 diabetes to date, enrolled more than 2,700 participants across 15 countries.
AI Summary
Eli Lilly announced positive topline results from ACHIEVE-4, a Phase 3 trial testing Foundayo (orforglipron) against insulin glargine in adults with type 2 diabetes who are obese or overweight and at increased cardiovascular risk. ACHIEVE-4 is the largest and longest Foundayo study in type 2 diabetes so far, enrolling more than 2,700 participants across 15 countries.
Foundayo met the trial’s primary objective of non-inferiority versus insulin glargine and showed meaningful cardiovascular differences: a 16% lower risk of MACE-4 events and a 23% lower risk of MACE-3 events. In a pre-planned analysis, all-cause death was 57% lower with Foundayo, suggesting broader health benefits. Based on these data, Lilly plans to submit Foundayo for the treatment of type 2 diabetes to the U.S. FDA by the end of Q2 under the Commissioner’s National Priority Review Voucher.
Read Announcement- Drug:
- orforglipron
- Announced Date:
- April 10, 2026
- Indication:
- Orforglipron for the treatment of obesity and overweight
Announcement
LifeMD, Inc announced that it is now offering Foundayo™ (orforglipron) to eligible patients through its weight management program. Foundayo, developed by Eli Lilly and Company, is a once daily oral treatment for adults with obesity or overweight with weight-related medical problems.
AI Summary
LifeMD, Inc. said it is now offering Foundayo™ (orforglipron) to eligible patients through its weight management program. Foundayo, developed by Eli Lilly and Company, is a once‑daily oral treatment for adults with obesity or who are overweight and have weight‑related medical problems. LifeMD will make the medicine available as part of its clinically guided care pathway for patients seeking medical support for weight loss.
The addition of Foundayo expands LifeMD’s lineup of branded GLP‑1 therapies from both Lilly and Novo Nordisk. LifeMD said the move reinforces its role as a destination for clinically guided weight management using prescription medications, and supports broader access to newer treatment options.
Representatives from Lilly noted the company’s focus on advancing treatments and widening access. Patients interested in Foundayo should consult LifeMD clinicians to determine eligibility and whether the medication fits their care plan.Read Announcement
- Drug:
- orforglipron
- Announced Date:
- April 9, 2026
- Indication:
- Orforglipron for the treatment of obesity and overweight
Announcement
GoodRx with Eli Lilly and Company to expand access to the newly FDA-approved oral GLP-1 medication, Foundayo™ (orforglipron).
AI Summary
GoodRx and Eli Lilly are partnering to expand access to Foundayo (orforglipron), a newly FDA‑approved oral GLP‑1 medication. The collaboration aims to make the drug more affordable and easier to obtain for people paying out of pocket.
Eligible self‑pay consumers can get Foundayo starting at $149 per month through GoodRx. That price is designed to lower out‑of‑pocket costs for patients who do not use insurance.
The effort supports new access models for drug launches by using third‑party platforms to provide pricing options and patient support. GoodRx will help consumers compare choices and find discounts for Foundayo.
GoodRx is a prescription savings platform that connects consumers to coupons, discounts, and pricing information to reduce medication costs.
Read Announcement- Drug:
- orforglipron
- Announced Date:
- April 1, 2026
- Indication:
- Orforglipron for the treatment of obesity and overweight
Announcement
Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) for adults with obesity, or overweight with weight-related medical problems.
AI Summary
Eli Lilly announced the FDA approved Foundayo (orforglipron) for adults with obesity, or adults with overweight and weight-related medical problems. In the ATTAIN-1 trial, people on the highest dose lost an average of 27 pounds.
Foundayo will be available through LillyDirect with free home delivery, costing $25 per month with commercial coverage or $149 for self-pay. Joe Nadglowski said new options expand choice and help people find care that fits their lives.
Foundayo is used with a reduced-calorie diet and increased physical activity. Do not use it with other GLP-1 receptor agonists; safety in children is unknown. Serious risks: thyroid tumors (including cancer); pancreatitis; severe stomach problems; dehydration causing kidney injury; allergic reactions; vision changes in people with type 2 diabetes; gallbladder problems; and risk of inhaling food during surgery. Talk with your healthcare provider about benefits and risks.
Read Announcement- Drug:
- orforglipron
- Announced Date:
- October 15, 2025
- Indication:
- Orforglipron for the treatment of obesity and overweight
Announcement
Eli Lilly and Company announced positive topline results from the Phase 3 ACHIEVE-2 and ACHIEVE-5 trials. ACHIEVE-2, the second head-to-head trial in the program, evaluated orforglipron versus dapagliflozin, an SGLT-2 inhibitor, in adults with type 2 diabetes inadequately controlled on metformin.
AI Summary
Eli Lilly announced that orforglipron showed strong results in two Phase 3 trials, ACHIEVE-2 and ACHIEVE-5, for adults with type 2 diabetes. Both studies met their primary and key secondary endpoints at 40 weeks, demonstrating significant A1C reductions, weight loss, and improvements in cardiovascular risk factors.
In the head-to-head ACHIEVE-2 trial, people on metformin who took orforglipron (12 mg or 36 mg) saw A1C drop by up to 1.7%, compared with a 0.8% drop on dapagliflozin, a widely used SGLT-2 inhibitor. This result highlights orforglipron’s superiority over an established therapy.
In ACHIEVE-5, adding orforglipron to titrated insulin glargine lowered A1C by up to 2.1%, versus 0.8% with placebo. The drug’s safety profile was consistent with earlier studies, with mainly mild-to-moderate gastrointestinal side effects. Lilly will share full data at upcoming medical meetings.
Read Announcement- Drug:
- orforglipron
- Announced Date:
- September 17, 2025
- Indication:
- Orforglipron for the treatment of obesity and overweight
Announcement
Eli Lilly and Company announced positive topline results from ACHIEVE-3, an open-label randomized Phase 3 clinical trial evaluating the safety and efficacy of orforglipron compared to oral semaglutide, administered according to approved label instructions, in 1,698 adults with type 2 diabetes inadequately controlled with metformin.
AI Summary
Eli Lilly’s ACHIEVE-3 trial enrolled 1,698 adults with type 2 diabetes whose blood sugar was not well controlled with metformin. Over 52 weeks, participants received orforglipron (12 or 36 mg) or oral semaglutide (7 or 14 mg).
For the primary endpoint, orforglipron at 36 mg lowered A1C by 2.2 percent, compared to a 1.4 percent drop with the highest dose of semaglutide. At the lower 12 mg dose, orforglipron reduced A1C by 1.9 percent versus 1.1 percent for semaglutide.
In a key secondary measure, the highest dose of orforglipron led to an average weight loss of 19.7 pounds (9.2 percent) versus 11.0 pounds (5.3 percent) with semaglutide, a 73.6 percent greater reduction.
The safety and tolerability of orforglipron matched earlier studies, with mainly mild to moderate gastrointestinal effects. These results suggest orforglipron could become a strong treatment for type 2 diabetes.
Read Announcement- Drug:
- orforglipron
- Announced Date:
- August 26, 2025
- Indication:
- Orforglipron for the treatment of obesity and overweight
Announcement
Eli Lilly and Company announced positive topline results from the Phase 3 ATTAIN-2 trial, evaluating orforglipron, an investigational oral GLP-1 receptor agonist, in adults with obesity or overweight and type 2 diabetes.
AI Summary
Eli Lilly announced topline results from the ATTAIN-2 Phase 3 trial of orforglipron, an oral GLP-1 receptor agonist, in adults with obesity or type 2 diabetes. The study showed the pill may match injectable treatments and expand options for those who prefer oral therapy.
All three doses met primary and secondary endpoints at 72 weeks. Participants on the highest 36 mg dose lost an average of 10.5% of their weight (22.9 lbs) versus 2.2% (5.1 lbs) with placebo. They also lowered A1C by about 1.8% on average, with 75% reaching a 6.5% A1C or below. The drug improved non-HDL cholesterol, blood pressure, and inflammation markers.
The safety profile matched that of injectable GLP-1 drugs. Most side effects were mild or moderate gastrointestinal issues. With these data, Lilly plans global regulatory submissions to offer a once-daily pill worldwide.
Read Announcement- Drug:
- orforglipron
- Announced Date:
- August 7, 2025
- Indication:
- Orforglipron for the treatment of obesity and overweight
Announcement
Eli Lilly and Company announced positive topline results from the Phase 3 ATTAIN-1 trial, evaluating orforglipron, an investigational oral glucagon-like peptide-1 (GLP-1) receptor agonist, in 3,127 adults with obesity, or overweight with a weight-related medical problem and without diabetes.
AI Summary
In the Phase 3 ATTAIN-1 trial, Eli Lilly tested orforglipron, a once-daily oral GLP-1 agonist, in 3,127 adults with obesity or overweight and no diabetes. Participants received 6, 12, or 36 mg orforglipron or placebo for 72 weeks alongside diet and exercise.
All doses met the primary and key secondary endpoints. The 36 mg dose led to an average weight loss of 12.4% (27.3 lbs) versus 0.9% (2.2 lbs) with placebo. At this dose, 59.6% lost at least 10% of their body weight and 39.6% lost at least 15%.
It also improved heart risk markers, reducing non-HDL cholesterol, triglycerides, systolic blood pressure, and lowering hsCRP by 47.7% at the highest dose.
The safety profile matched injectable GLP-1 treatments, mainly mild-to-moderate gastrointestinal events. Lilly plans to submit orforglipron for regulatory review by year-end and is investing to meet launch demand.
Read Announcement
Pirtobrutinib FDA Regulatory Timeline and Events
Pirtobrutinib is a drug developed by Eli Lilly and Company for the following indication: A non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Pirtobrutinib
- Announced Date:
- April 13, 2026
- Indication:
- A non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult
Announcement
Eli Lilly and Company announced positive topline results from the Phase 3 BRUIN CLL-322 trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, plus venetoclax and rituximab versus venetoclax and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
AI Summary
Eli Lilly announced positive topline results from the Phase 3 BRUIN CLL-322 trial testing Jaypirca (pirtobrutinib), a non‑covalent (reversible) BTK inhibitor, in combination with venetoclax and rituximab versus venetoclax and rituximab alone for patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study is the first Phase 3 CLL trial to use and outperform a venetoclax‑containing control arm and largely enrolled patients previously treated with covalent BTK inhibitors, making the findings highly relevant to current clinical practice. These topline results represent the fourth positive Phase 3 study of pirtobrutinib in CLL, indicating consistent benefit across trials.
Detailed data will be presented at a medical congress and submitted to a peer‑reviewed journal. Lilly plans to submit the full results to regulators later this year seeking a label expansion for Jaypirca.Read Announcement
- Drug:
- Pirtobrutinib
- Announced Date:
- December 9, 2025
- Indication:
- A non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult
Announcement
Eli Lilly and Company announced results from the Phase 3 BRUIN CLL-313 clinical trial of Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, versus bendamustine plus rituximab (BR), in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions.
AI Summary
Eli Lilly reported results from the Phase 3 BRUIN CLL-313 trial comparing Jaypirca (pirtobrutinib), a non‑covalent BTK inhibitor, to bendamustine plus rituximab (BR) in 282 treatment‑naïve CLL/SLL patients without del(17p). Patients were randomized 1:1 to pirtobrutinib 200 mg daily (n=141) or BR (n=141). At a median 28.1 months follow‑up, pirtobrutinib cut the risk of disease progression or death by 80% (HR 0.20; 95% CI 0.11–0.37; p<0.0001). The progression‑free survival benefit was seen across predefined subgroups, including patients with high‑risk features. Overall survival data are immature but showed a favorable trend (HR 0.257; p=0.0261) despite 52.9% of BR patients crossing over to pirtobrutinib after progression.
Safety was consistent with prior reports: grade ≥3 treatment‑emergent adverse events occurred in 40.0% with pirtobrutinib versus 67.4% with BR, with fewer dose reductions (3.6% vs 31.1%) and discontinuations (4.3% vs 15.2%). Rates of atrial fibrillation/flutter were similar between arms. Investigators described the PFS benefit as one of the most pronounced seen for a single‑agent BTK inhibitor in front‑line CLL, supporting pirtobrutinib’s potential role in newly diagnosed patients.
Read Announcement- Drug:
- Pirtobrutinib
- Announced Date:
- December 7, 2025
- Indication:
- A non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult
Announcement
Eli Lilly and Company announced results from the Phase 3 BRUIN CLL-314 clinical trial evaluating Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who were treatment-naïve or were BTK inhibitor-naïve.
AI Summary
Eli Lilly reported Phase 3 BRUIN CLL-314 results comparing Jaypirca (pirtobrutinib), a non‑covalent BTK inhibitor, with Imbruvica (ibrutinib) in 662 patients with CLL/SLL who were treatment‑naïve or BTK‑inhibitor‑naïve. Pirtobrutinib met the primary endpoint of non‑inferiority for independent review‑committee assessed overall response rate (ORR): 87.0% (95% CI 82.9–90.4) versus 78.5% (95% CI 73.7–82.9) for ibrutinib (nominal p = 0.0035).
Progression‑free survival data were immature but trended toward benefit with pirtobrutinib: ITT HR = 0.569 (about a 43% reduction in risk of progression or death), relapsed/refractory HR = 0.729, and a 76% risk reduction in the treatment‑naïve subgroup (HR = 0.239). Median follow‑up was roughly 22 months for key groups.
Safety profiles were broadly similar, with lower rates of atrial fibrillation/flutter (2.4% vs 13.5%) and hypertension (10.6% vs 15.1%) on pirtobrutinib, and fewer dose reductions and discontinuations. The data will be published in the Journal of Clinical Oncology and presented at ASH 2025.
Read Announcement- Drug:
- Pirtobrutinib
- Announced Date:
- December 3, 2025
- Indication:
- A non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult
Announcement
Eli Lilly And Co announced that the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.
Read Announcement- Drug:
- Pirtobrutinib
- Announced Date:
- November 24, 2025
- Indication:
- A non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult
Announcement
Eli Lilly and Company announced that data from studies of Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, will be presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place Dec. 6-9 in Orlando, Florida.
AI Summary
Eli Lilly announced that data from studies of Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, will be presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, Dec. 6–9 in Orlando, Florida. The company said the presentations will share clinical findings that help clinicians understand Jaypirca’s role in treating B‑cell malignancies.
The ASH presentations are expected to include results on safety, effectiveness, and how Jaypirca performs in patients who have stopped responding to covalent BTK inhibitors. Because Jaypirca binds reversibly, it may overcome certain resistance mutations and offer an alternative option for patients with relapsed or refractory disease. Lilly emphasized the importance of these data for informing treatment decisions and advancing care for people with blood cancers. Full details and abstracts will be available through the ASH program.
Read Announcement- Drug:
- Pirtobrutinib
- Announced Date:
- September 8, 2025
- Indication:
- A non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult
Announcement
Eli Lilly and Company announced positive topline results from the Phase 3 BRUIN CLL-313 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, versus chemoimmunotherapy (bendamustine plus rituximab), in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions.
AI Summary
Eli Lilly announced positive topline results from its Phase 3 BRUIN CLL-313 trial of Jaypirca (pirtobrutinib), a reversible BTK inhibitor, in previously untreated CLL/SLL patients.
The study randomly assigned 282 adults without 17p deletions to receive either daily pirtobrutinib or the chemoimmunotherapy combination bendamustine plus rituximab.
It met its primary endpoint by showing a highly significant and clinically meaningful improvement in progression-free survival versus chemoimmunotherapy, as judged by an independent review committee.
Overall survival data are not yet mature, but early trends favor pirtobrutinib, with a formal analysis expected in 2026.
The safety profile of pirtobrutinib was consistent with earlier studies and generally well tolerated across frontline CLL/SLL patients.
Detailed results will be presented at medical congresses, and Lilly plans global regulatory submissions later this year to expand pirtobrutinib’s label to earlier lines of therapy.
Read Announcement- Drug:
- Pirtobrutinib
- Announced Date:
- July 29, 2025
- Indication:
- A non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult
Announcement
Eli Lilly and Company announced positive topline results from the Phase 3 BRUIN CLL-314 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
AI Summary
Eli Lilly announced positive topline results from the Phase 3 BRUIN CLL-314 trial of Jaypirca (pirtobrutinib), a non-covalent BTK inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). This randomized study enrolled both treatment-naïve and previously treated but BTK inhibitor-naïve patients.
The trial met its primary endpoint of non-inferiority for overall response rate (ORR) by independent review. ORR favored pirtobrutinib (P<0.05). Progression-free survival (PFS) was immature but trended in favor of pirtobrutinib, with a planned formal analysis for superiority.
This was the first head-to-head Phase 3 study comparing non-covalent and covalent BTK inhibitors in CLL/SLL, including treatment-naïve patients. Safety was similar to earlier trials, and no harm to overall survival was seen. Detailed data will be shared at a medical meeting in 2025.
Read Announcement- Drug:
- Pirtobrutinib
- Announced Date:
- February 28, 2025
- Indication:
- A non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult
Announcement
Eli Lilly and Company announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have been previously treated with a BTK inhibitor.
AI Summary
Eli Lilly announced that the EMA’s CHMP has issued a positive opinion for Jaypirca (pirtobrutinib) for treating adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have previously received a BTK inhibitor. This decision follows promising results from the Phase 3 BRUIN CLL-321 trial—the first randomized Phase 3 study in CLL conducted exclusively with patients after BTK inhibitor treatment. The trial demonstrated that Jaypirca significantly improved progression-free survival and delayed the time to the next treatment by reducing the risk of disease progression or death by 46% compared to standard treatment options. With these promising findings, the positive opinion marks an important milestone, as the application now moves to the European Commission for final approval, expected within the next one to two months, potentially offering a promising new treatment option in a setting of high unmet medical need.
Read Announcement- Drug:
- Pirtobrutinib
- Announced Date:
- December 9, 2024
- Indication:
- A non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult
Announcement
Eli Lilly and Company announced results from the Phase 3 BRUIN CLL-321 trial evaluating pirtobrutinib, a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor in adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) previously treated with a covalent BTK inhibitor.
AI Summary
Eli Lilly announced positive final results from its Phase 3 BRUIN CLL-321 trial, which evaluated pirtobrutinib—a non-covalent, reversible BTK inhibitor—in adults with chronic lymphocytic leukemia or small lymphocytic lymphoma previously treated with a covalent BTK inhibitor. The trial met its primary endpoint, showing that pirtobrutinib reduced the risk of disease progression or death by 46% compared to treatments chosen by investigators (idelalisib plus rituximab or bendamustine plus rituximab). Notably, patients receiving pirtobrutinib experienced a median time to next treatment or death of 23.9 months, nearly doubling the 10.9 months seen in the control arm. These promising results, achieved in a challenging patient population, highlight pirtobrutinib’s potential to offer a new treatment option and enhance outcomes for patients with prior BTK inhibitor therapy.
Read Announcement
Taltz FDA Regulatory Events
Taltz is a drug developed by Eli Lilly and Company for the following indication: adults with psoriasis and obesity or overweight.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Taltz
- Announced Date:
- March 28, 2026
- Indication:
- adults with psoriasis and obesity or overweight
Announcement
Eli Lilly and Company announced detailed results from the TOGETHER-PsA open-label Phase 3b clinical trial evaluating the concomitant use of Taltz (ixekizumab) and Zepbound (tirzepatide) compared to Taltz alone in adults with active psoriatic arthritis (PsA) and obesity or overweight with at least one additional weight-related comorbid condition.
AI Summary
Eli Lilly announced detailed results from the TOGETHER‑PsA open‑label Phase 3b clinical trial, which compared the combined use of Taltz (ixekizumab) and Zepbound (tirzepatide) with Taltz alone. The study enrolled adults with active psoriatic arthritis who were obese or overweight and had at least one additional weight‑related comorbid condition. As an open‑label, late‑stage trial, it explored real‑world effects of adding tirzepatide to standard biologic therapy.
The trial examined efficacy measures for joint and skin symptoms, weight‑related outcomes, safety, and patient‑reported measures to see if combination therapy offers added benefit over ixekizumab alone. Lilly said the detailed findings will help inform clinicians and patients about the potential role of combined treatment for people with PsA and excess weight, guiding clinical decisions and future research directions.Read Announcement
- Drug:
- Taltz
- Announced Date:
- February 18, 2026
- Indication:
- adults with psoriasis and obesity or overweight
Announcement
Eli Lilly and Company announced positive topline results from the landmark TOGETHER-PsO open-label Phase 3b clinical trial evaluating the concomitant use of Taltz (ixekizumab) and Zepbound (tirzepatide) compared to Taltz alone in adults with moderate-to-severe plaque psoriasis and obesity or overweight with at least one additional weight-related comorbid condition.
AI Summary
Eli Lilly announced positive topline results from the open‑label Phase 3b TOGETHER‑PsO trial testing concomitant Taltz (ixekizumab) and Zepbound (tirzepatide) versus Taltz alone in adults with moderate‑to‑severe plaque psoriasis who are obese or overweight with at least one weight‑related comorbidity.
At 36 weeks the combination met the primary endpoint, showing superiority over Taltz monotherapy for complete skin clearance (PASI 100) and for achieving ≥10% weight loss. In a key secondary outcome, patients taking both drugs were 40% more likely to reach PASI 100 (40.6% vs. 29.0%, p<0.05). Lilly noted Taltz is the first psoriatic disease biologic with data from two trials supporting a potential comprehensive treatment approach alongside an incretin therapy for obesity. Detailed 36‑week results will be published in a peer‑reviewed journal and discussed with regulators.
Read Announcement
EBGLYSS FDA Regulatory Timeline and Events
EBGLYSS is a drug developed by Eli Lilly and Company for the following indication: For atopic dermatitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EBGLYSS
- Announced Date:
- March 27, 2026
- Indication:
- For atopic dermatitis
Announcement
Eli Lilly and Company EBGLYSS (lebrikizumab-lbkz) delivered durable skin clearance and relief from persistent itch for up to four years for patients with moderate-to-severe atopic dermatitis (eczema) in an open-label extension study offering once-monthly maintenance injection.
AI Summary
In the ADlong Phase 3b open-label extension, EBGLYSS (lebrikizumab-lbkz) given as a once-monthly maintenance injection produced durable skin clearance and itch relief for up to four years in patients with moderate-to-severe atopic dermatitis. Nearly all treated patients achieved meaningful skin improvement (EASI-75), 75% reached near-complete clearance (EASI-90), and 78% reported significant itch relief (Pruritus NRS ≤4). Most patients (77%) were on EBGLYSS alone, and 80% achieved these outcomes without using topical corticosteroids.
The results reflect long-term outcomes from Lilly’s EBGLYSS program. EBGLYSS is available as a 250 mg/2 mL prefilled pen or syringe. Common side effects include eye or eyelid inflammation, injection site reactions, and shingles; safety in children under 12 or in some adolescents under 40 kg is unknown. Patients should discuss medical conditions and medications with their healthcare provider.Read Announcement
- Drug:
- EBGLYSS
- Announced Date:
- March 16, 2026
- Indication:
- For atopic dermatitis
Announcement
Eli Lilly and Company announced positive, topline results from the Phase 3 ADorable-1 trial evaluating the safety and efficacy of EBGLYSS (lebrikizumab-lbkz) in pediatric patients with moderate-to-severe atopic dermatitis. EBGLYSS met the primary and key secondary endpoints at Week 16, improving disease severity while delivering skin clearance and relief from persistent itch.
AI Summary
Eli Lilly reported positive topline Phase 3 ADorable-1 results for EBGLYSS (lebrikizumab-lbkz) in pediatric patients with moderate-to-severe atopic dermatitis. EBGLYSS met the primary and key secondary endpoints at Week 16: 63% of patients achieved EASI-75 (meaningful skin improvement), 44% reached IGA 0/1 (clear or almost clear), 39% achieved EASI-90 (near-complete clearance), and 35% had a ≥4‑point improvement in itch (Pruritus NRS).
The safety and tolerability profile was consistent with adult and adolescent studies, with no new safety signals and no injection site pain reported. The most common adverse events (≥5%) were upper respiratory tract infections and nasopharyngitis. Injection site reactions occurred at similar rates in EBGLYSS and placebo groups. Known side effects include eye and eyelid inflammation and shingles.
The ADorable program is ongoing, and additional results from ADorable-1 and the 52‑week ADorable-2 extension will be disclosed later this year. It is not known if EBGLYSS is safe and effective in children under 12 or in 12–<18‑year‑olds weighing less than 88 lb (40 kg).
Read Announcement- Drug:
- EBGLYSS
- Announced Date:
- March 7, 2025
- Indication:
- For atopic dermatitis
Announcement
Eli Lilly and Company's announced that New results show Eli Lilly and Company's EBGLYSS achieved deep and sustained response for patients with moderate-to-severe atopic dermatitis (eczema) at three years.
AI Summary
Eli Lilly and Company announced new three-year results from its long-term extension study, ADjoin, showing that EBGLYSS delivers deep and sustained improvement for patients with moderate-to-severe atopic dermatitis (eczema). In the study, 50% of patients who responded at Week 16 achieved complete skin clearance (EASI 100 or IGA 0) after three years with a monthly maintenance dose. Additionally, 87% attained or maintained almost-clear skin (EASI 90) over the same period. These results highlight EBGLYSS’ effectiveness as a first-line monotherapy biologic treatment option for patients whose eczema is not well controlled by topical therapies. The data, which will be presented at the American Academy of Dermatology Annual Meeting, underscore the potential for long-term disease control and improved quality of life for many individuals suffering from moderate-to-severe atopic dermatitis.
Read Announcement- Drug:
- EBGLYSS
- Announced Date:
- November 19, 2024
- Indication:
- For atopic dermatitis
Announcement
Eli Lilly Canada Inc. announced that it is disappointed and strongly disagrees with Canada's Drug Agency (CDA-AMC)'s Final Recommendation for Ebglyss™ (lebrikizumab), published on Friday, November 15, 2024.
Read Announcement- Drug:
- EBGLYSS
- Announced Date:
- September 25, 2024
- Indication:
- For atopic dermatitis
Announcement
Eli Lilly and Company announced these new long-term results from the ADjoin long-term extension study, which will be presented at the European Academy of Dermatology and Venereology (EADV) Congress from Sept. 25-28 in Amsterdam, Netherlands.1
AI Summary
Eli Lilly and Company announced new long-term results from the ADjoin extension study of EBGLYSS, a treatment for moderate-to-severe atopic dermatitis. The data showed that patients who responded in the earlier ADvocate 1 and 2 trials maintained clear or almost-clear skin for up to three years with monthly maintenance dosing. Notably, nearly 87% of patients did not require high-potency topical corticosteroids or systemic treatments during the study, and the safety profile remained consistent with earlier findings.
These encouraging results support the durable efficacy of EBGLYSS as an interleukin-13 (IL-13) inhibitor, offering long-term relief from the symptoms of eczema. The detailed findings from the ADjoin study will be presented at the European Academy of Dermatology and Venereology Congress, held from September 25-28 in Amsterdam, Netherlands.
Read Announcement
Baricitinib FDA Regulatory Events
Baricitinib is a drug developed by Eli Lilly and Company for the following indication: Moderate to severe Atopic Dermatitis (AD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Baricitinib
- Announced Date:
- February 27, 2026
- Indication:
- Moderate to severe Atopic Dermatitis (AD)
Announcement
Eli Lilly and Company and Incyte announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Olumiant (baricitinib) for the treatment of adolescents (ages 12 to <18) with severe alopecia areata (AA).
AI Summary
Eli Lilly and Incyte said the European Medicines Agency’s CHMP has issued a positive opinion for Olumiant (baricitinib) to treat adolescents ages 12 to under 18 with severe alopecia areata (AA). The recommendation is based on Phase 3 BRAVE‑AA‑PEDS results showing 42% of treated patients achieved 80% or more scalp hair coverage at 36 weeks. Many participants also experienced eyebrow and eyelash regrowth, and treatment produced near‑complete scalp regrowth for a substantial share of patients.
BRAVE‑AA‑PEDS is the first and largest trial designed specifically for children and adolescents with severe AA, a disease that can have serious social and emotional effects. The safety profile in adolescents was consistent with that seen in pediatric trials for other conditions. The CHMP opinion is now referred to the European Commission for a final decision, expected within about one to two months, potentially expanding treatment options for young people with severe AA.
Read Announcement- Drug:
- Baricitinib
- Announced Date:
- October 24, 2025
- Indication:
- Moderate to severe Atopic Dermatitis (AD)
Announcement
New results from Eli Lilly and Company ) showed once-daily, oral baricitinib 4 mg helped the majority of adolescent patients (ages 12 to <18) with severe alopecia areata (AA) achieve successful hair regrowth on the scalp, eyebrows and eyelashes at one year.
AI Summary
The BRAVE-AA-PEDS trial is the first and largest study specifically designed for adolescents (ages 12 to <18) with severe alopecia areata. At the start, participants had an average of 89% scalp hair loss and many had minimal or no eyebrow and eyelash hair.
After one year of once-daily, oral baricitinib 4 mg, 71% of adolescents with severe disease achieved successful scalp hair regrowth (≥80% coverage), and 41.2% reached near-complete regrowth (≥90% coverage). Significant eyebrow improvements were seen in 64.8% of patients, with 63.3% achieving meaningful eyelash regrowth. Hair coverage continued to improve throughout the 52-week study.
The safety profile in adolescents was consistent with adult data, with common side effects including acne and upper respiratory infections. Lilly plans to submit the BRAVE-AA-PEDS results to global regulators for a possible label update for baricitinib (Olumiant).
Read Announcement
Sofetabart mipitecan FDA Regulatory Events
Sofetabart mipitecan is a drug developed by Eli Lilly and Company for the following indication: treatment of certain patients with platinum-resistant ovarian cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Sofetabart mipitecan
- Announced Date:
- January 20, 2026
- Indication:
- treatment of certain patients with platinum-resistant ovarian cancer
Announcement
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sofetabart mipitecan (LY4170156) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received prior bevacizumab and mirvetuximab soravtansine, if eligible.
AI Summary
Eli Lilly announced the FDA has granted Breakthrough Therapy designation to sofetabart mipitecan (LY4170156) for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received prior bevacizumab and mirvetuximab soravtansine, if eligible. The designation is meant to speed development and review for drugs that may offer substantial improvement over existing treatments.
Sofetabart mipitecan is a new folate receptor alpha (FRα) antibody-drug conjugate that pairs an FRα-specific, Fc-silent antibody with the chemotherapy payload exatecan using a proprietary cleavable polysarcosine linker. Early Phase 1 results showed tumor responses across all FRα expression levels, including in patients who progressed after mirvetuximab, and indicated a generally favorable safety profile with low rates of interstitial lung disease, peripheral neuropathy, and alopecia and no significant eye toxicity.
The drug has advanced to the global Phase 3 FRAmework-01 study as a monotherapy for platinum-resistant disease and in combination with bevacizumab for platinum-sensitive disease, aiming to expand treatment options for patients.
Read Announcement
TOGETHER-PsA FDA Regulatory Events
TOGETHER-PsA is a drug developed by Eli Lilly and Company for the following indication: for adults with active psoriatic arthritis and obesity or overweight.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TOGETHER-PsA
- Announced Date:
- January 8, 2026
- Indication:
- for adults with active psoriatic arthritis and obesity or overweight
Announcement
Eli Lilly and Company announced positive topline results from the novel TOGETHER-PsA open-label Phase 3b trial evaluating the concomitant use of Taltz (ixekizumab) and Zepbound (tirzepatide) compared to Taltz alone in adults with active psoriatic arthritis (PsA) and obesity or overweight with at least one weight-related condition.
AI Summary
Eli Lilly reported topline results from TOGETHER-PsA, a Phase 3b trial testing Taltz plus Zepbound versus Taltz alone in adults with active psoriatic arthritis who are obese or overweight with at least one weight-related condition. At 36 weeks the study met its primary endpoint: 31.7% of patients on the combination achieved both ACR50 and ≥10% weight loss versus 0.8% on Taltz alone (p<.001).
For a key secondary endpoint, the combination gave a 64% relative increase in ACR50 compared with Taltz alone (33.5% vs 20.4%, p<.05). The trial enrolled 271 participants (mean BMI 37.6); over 60% had prior advanced therapy.
Adverse events with the combination were generally mild to moderate; common events included nausea, diarrhea, constipation and injection-site reactions. Lilly said the findings support an integrated treatment approach linking biologic therapy and weight management. Detailed 36-week data will be presented.
Read Announcement
Imlunestrant FDA Regulatory Timeline and Events
Imlunestrant is a drug developed by Eli Lilly and Company for the following indication: oral selective estrogen receptor degrader.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Imlunestrant
- Announced Date:
- December 12, 2025
- Indication:
- oral selective estrogen receptor degrader
Announcement
Eli Lilly and Company announced updated results from the Phase 3 EMBER-3 study of Inluriyo (imlunestrant), an oral estrogen receptor antagonist, in patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2–negative (HER2–) advanced or metastatic breast cancer (MBC), whose disease progressed on a prior aromatase inhibitor (AI), with or without a CDK4/6 inhibitor.
AI Summary
Eli Lilly reported updated Phase 3 EMBER-3 results for Inluriyo (imlunestrant), an oral estrogen receptor antagonist, in adults with ER+, HER2− advanced or metastatic breast cancer after progression on an aromatase inhibitor, with or without prior CDK4/6 inhibitor.
In patients with ESR1 mutations, imlunestrant alone cut the risk of progression or death by 38% (median PFS 5.5 vs 3.8 months; HR 0.62) and produced an 11.4‑month longer median overall survival (34.5 vs 23.1 months; HR 0.60), although the formal OS significance boundary was not met. Safety remained consistent with earlier reports and no new signals were observed.
Across all patients, adding abemaciclib nearly doubled median PFS versus imlunestrant alone (10.9 vs 5.5 months; HR 0.59), showed a favorable OS trend (HR 0.82), and delayed time to chemotherapy by over a year (27.8 vs 15.5 months). Benefits were seen regardless of ESR1 status; 65% of combination patients had prior CDK4/6 inhibitor. The data were published in Annals of Oncology and presented at the San Antonio Breast Cancer Symposium, and Lilly has submitted the combination data for U.S. regulatory review in ESR1‑mutated MBC.
Read Announcement- Drug:
- Imlunestrant
- Announced Date:
- September 25, 2025
- Indication:
- oral selective estrogen receptor degrader
Announcement
Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET).
AI Summary
The U.S. Food and Drug Administration has approved Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist, to treat adults with estrogen receptor-positive (ER+), HER2-negative breast cancer that harbors ESR1 mutations and has progressed after at least one line of endocrine therapy. Inluriyo offers a new option for patients whose tumors often become resistant to aromatase inhibitors.
In the Phase 3 EMBER-3 trial, Inluriyo monotherapy cut the risk of disease progression or death by 38% compared to standard endocrine therapy. Among patients with ESR1-mutated metastatic breast cancer, median progression-free survival was 5.5 months with Inluriyo versus 3.8 months with fulvestrant or exemestane (HR=0.62; p=0.0008).
Inluriyo works by binding to estrogen receptors, blocking their activity and promoting their degradation. Taken once daily, it provides a convenient oral treatment for patients facing advanced, hormone-driven breast cancer.
Read Announcement- Drug:
- Imlunestrant
- Announced Date:
- May 22, 2025
- Indication:
- oral selective estrogen receptor degrader
Announcement
Eli Lilly and Company announced that data from studies of imlunestrant, an investigational oral selective estrogen receptor degrader (SERD), olomorasib, an investigational KRAS G12C inhibitor, LY4170156, an investigational antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) and Verzenio® (abemaciclib; a CDK4/6 inhibitor) will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 - June 3 in Chicago.
AI Summary
Eli Lilly and Company announced that key data from four studies will be presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago from May 30 to June 3. The presentation will include findings on imlunestrant, an investigational oral selective estrogen receptor degrader (SERD) for advanced breast cancer, along with olomorasib, an investigational KRAS G12C inhibitor showing promise with central nervous system activity. Additionally, early results from LY4170156, an investigational antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) in patients with platinum-resistant ovarian cancer, will be highlighted. Updates on Verzenio® (abemaciclib), a CDK4/6 inhibitor currently used to treat certain breast cancers, will also be featured. The sessions will focus on patient-reported outcomes, safety data, and combination therapy insights to further guide future treatment approaches in oncology.
Read Announcement
Eloralintide FDA Regulatory Events
Eloralintide is a drug developed by Eli Lilly and Company for the following indication: treatment of obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- eloralintide
- Announced Date:
- November 6, 2025
- Indication:
- treatment of obesity
Announcement
Eli Lilly and Company announced positive results from a Phase 2 trial evaluating the safety and efficacy of eloralintide, an investigational once-weekly, selective amylin receptor agonist, in 263 adults with obesity or overweight with at least one obesity-related comorbidity and without type 2 diabetes.
AI Summary
Eli Lilly announced positive Phase 2 results for eloralintide, an investigational once-weekly selective amylin receptor agonist. The trial enrolled 263 adults with obesity or overweight who had at least one obesity-related health problem and no type 2 diabetes. At 48 weeks, all doses achieved weight loss from 9.5% to 20.1%, versus 0.4% for placebo.
Participants also saw drops in body mass index and improvements in waist size, blood pressure, lipids, blood sugar control, and inflammation markers. The most common side effects were mild to moderate gastrointestinal issues and fatigue. These were more frequent at higher doses but declined with slower dose escalation, matching placebo rates in the 1 mg and 3 mg arms.
Based on these results, Lilly will start Phase 3 enrollment next month to test eloralintide for obesity treatment. The company sees this therapy as a promising new option to expand obesity care.
Read Announcement
Verzenio plus endocrine therapy FDA Regulatory Events
Verzenio plus endocrine therapy is a drug developed by Eli Lilly and Company for the following indication: in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high-risk early breast cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Verzenio plus endocrine therapy
- Announced Date:
- October 17, 2025
- Indication:
- in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high-risk early breast cancer.
Announcement
Eli Lilly and Company announced results from the primary overall survival (OS) analysis of the Phase 3 monarchE trial showing that two years of adjuvant Verzenio plus endocrine therapy (ET) reduced the risk of death by 15.8% versus ET alone and resulted in sustained long-term improvements in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high-risk early breast cancer.
AI Summary
Eli Lilly reported the primary overall survival (OS) results from the Phase 3 monarchE trial, studying two years of adjuvant Verzenio (abemaciclib) plus endocrine therapy (ET) in patients with hormone receptor-positive (HR+), HER2-negative, node-positive, high-risk early breast cancer.
With a median follow-up of 6.3 years, Verzenio plus ET reduced the risk of death by 15.8% versus ET alone (7-year OS 86.8% vs. 85.0%; hazard ratio 0.842; p=0.027). More than 75% of patients were followed for at least four years after completing the two-year treatment.
Long-term benefits also appeared in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS). At seven years, 6.4% of patients on Verzenio plus ET were living with metastatic disease versus 9.4% on ET alone—a 32% reduction in metastatic recurrence.
These data, published in Annals of Oncology and presented in a late-breaking oral session at ESMO 2025, mark the first contemporary adjuvant therapy in over two decades to show a clear OS benefit in this high-risk population.
Read Announcement
Verzenio (abemaciclib) FDA Regulatory Timeline and Events
Verzenio (abemaciclib) is a drug developed by Eli Lilly and Company for the following indication: Hormone Receptor-Positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Verzenio (abemaciclib)
- Announced Date:
- October 13, 2025
- Indication:
- Hormone Receptor-Positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC)
Announcement
Eli Lilly and Company announced that new data from across its oncology portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) Annual Meeting, taking place October 17-21 in Berlin, Germany.
AI Summary
At the ESMO Annual Meeting in Berlin from October 17–21, Eli Lilly and Company will present new clinical data from across its oncology portfolio and research pipeline.
The highlight is Verzenio (abemaciclib), featured in a late-breaking oral session with primary overall survival results from the Phase 3 monarchE trial in HR +, HER2 –, node-positive, high-risk early breast cancer. Updated invasive disease-free and distant relapse-free survival analyses and a detailed Ki-67 index study will also be shared.
Additional presentations cover promising investigational therapies. These include: LY4170156, an antibody-drug conjugate targeting folate receptor α in platinum-resistant ovarian cancer; olomorasib for KRAS G12C-mutant lung cancer with brain metastases; vepugratinib for FGFR3-altered urothelial cancer; and LY4064809, a pan-mutant selective PI3Kα inhibitor in PIK3CA-mutant advanced breast cancer.
Together, these sessions showcase Lilly’s robust approach to advancing cancer care across multiple tumor types and treatment modalities.
Read Announcement- Drug:
- Verzenio (abemaciclib)
- Announced Date:
- August 27, 2025
- Indication:
- Hormone Receptor-Positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC)
Announcement
Eli Lilly Announced Topline Results Phase 3 MonarchE Trial.
AI Summary
Eli Lilly today announced positive topline results from the Phase 3 monarchE trial, which tested two years of Verzenio plus endocrine therapy against endocrine therapy alone in patients with hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence.
In the primary overall survival analysis, adding Verzenio led to a statistically significant and clinically meaningful improvement in overall survival compared to endocrine therapy alone. This shows that patients lived longer when Verzenio was part of their treatment.
At the seven-year landmark analysis, the combination also produced sustained benefits in invasive disease-free survival and distant relapse-free survival. These consistent gains reinforce two years of Verzenio plus endocrine therapy as the standard of care for this high-risk group.
All patients have completed or discontinued the two-year Verzenio course, and the safety profile remained consistent with previous reports. Detailed results will be shared at an upcoming medical meeting.
Read Announcement- Drug:
- Verzenio (abemaciclib)
- Announced Date:
- February 27, 2025
- Indication:
- Hormone Receptor-Positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC)
Announcement
Tango Therapeutics, Inc. provided business highlights.
AI Summary
Tango Therapeutics, Inc. shared key business updates as it heads into 2025. The company is advancing its lead PRMT5 program, TNG462, which recently received FDA Orphan Drug Designation for treating pancreatic cancer. Promising early clinical data have been observed, and more detailed data focusing on pancreatic and lung cancers is expected later this year. Tango plans to launch its first TNG462 monotherapy registrational study in pancreatic cancer next year and is set to begin enrollment in combination trials starting in the first half of 2025.
Additionally, the FDA cleared the Investigational New Drug (IND) application for TNG456, a next-generation brain-penetrant MTA-cooperative PRMT5 inhibitor, with Phase 1/2 trials anticipated soon. The company also announced a collaboration with Eli Lilly for evaluating TNG456 in combination with abemaciclib. With a cash position of $258 million, Tango expects to fund its operations into the third quarter of 2026.
Read Announcement- Drug:
- Verzenio (abemaciclib)
- Announced Date:
- December 11, 2024
- Indication:
- Hormone Receptor-Positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC)
Announcement
Eli Lilly and Company announced results from the Phase 3 EMBER-3 study of imlunestrant, an investigational, oral selective estrogen receptor degrader (SERD), in patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC), whose disease progressed on a prior aromatase inhibitor (AI), with or without a CDK4/6 inhibitor.
AI Summary
Eli Lilly and Company announced promising results from the Phase 3 EMBER-3 study of imlunestrant, an investigational, oral selective estrogen receptor degrader (SERD), in patients with ER+ and HER2- advanced breast cancer who progressed after previous aromatase inhibitor treatment, with or without a CDK4/6 inhibitor. In patients with ESR1 mutations, imlunestrant used as a monotherapy reduced the risk of disease progression or death by 38% compared to the standard endocrine therapy. When combined with Verzenio (abemaciclib), the risk reduction improved to 43% compared to imlunestrant alone, regardless of ESR1 mutation status. These encouraging results, indicating a potential new all-oral therapy option for this patient population, were published in the New England Journal of Medicine and will be presented at the 2024 San Antonio Breast Cancer Symposium.
Read Announcement- Drug:
- Verzenio (abemaciclib)
- Announced Date:
- August 21, 2024
- Indication:
- Hormone Receptor-Positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC)
Announcement
Atossa Therapeutics, Inc. and Quantum Leap Healthcare Collaborative™ (QLHC), announced the first patient has been dosed in their clinical trial evaluating Atossa's proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, as a neoadjuvant treatment in high-risk women with newly diagnosed Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.
AI Summary
Atossa Therapeutics, Inc. and Quantum Leap Healthcare Collaborative™ announced that the first patient has been dosed in a clinical trial testing an innovative treatment for high-risk women with newly diagnosed ER+ / HER2- breast cancer. The trial evaluates the use of Atossa’s proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a CDK 4/6 inhibitor marketed by Eli Lilly. This treatment is designed as a neoadjuvant therapy, meaning it is given before surgery to shrink tumors and potentially improve outcomes.
The study will enroll about 80 patients across two groups, including both premenopausal and postmenopausal women. It aims to offer a gentler, more patient-friendly treatment alternative by combining these therapies to enhance safety, efficacy, and quality of life. Data from this trial is anticipated in 2026.
Read Announcement- Drug:
- Verzenio (abemaciclib)
- Announced Date:
- May 23, 2024
- Indication:
- Hormone Receptor-Positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC)
Announcement
Eli Lilly and Company announced that data from studies of Verzenio® (abemaciclib; a CDK4/6 inhibitor), Retevmo® (selpercatinib; a rearranged during transfection [RET] inhibitor), olomorasib (an investigational KRAS G12C inhibitor) and imlunestrant (an investigational oral selective estrogen receptor degrader [SERD]) will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31 – June 4 in Chicago.
AI Summary
Eli Lilly and Company announced that they will present new clinical data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, scheduled for May 31 – June 4. The data will include results from studies involving four key therapies. Verzenio (abemaciclib), a CDK4/6 inhibitor, and Retevmo (selpercatinib), a RET inhibitor, will have their study outcomes shared. Additionally, data from studies on olomorasib—an investigational KRAS G12C inhibitor—and imlunestrant, an investigational oral selective estrogen receptor degrader (SERD), will also be presented. These presentations are designed to offer further insights into the safety and efficacy profiles of these treatments, potentially informing future cancer therapy strategies. The ASCO meeting will be an important platform for sharing these findings with the broader oncology community.Read Announcement
Donanemab FDA Regulatory Timeline and Events
Donanemab is a drug developed by Eli Lilly and Company for the following indication: Alzheimer's disease (AD).
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Donanemab
- Announced Date:
- September 25, 2025
- Indication:
- Alzheimer's disease (AD)
Announcement
Eli Lilly and Company announced today that the European Commission (EC) has granted marketing authorization for Kisunla (donanemab) for the treatment of early symptomatic Alzheimer's disease (AD), in adults with mild cognitive impairment as well as those with mild dementia stages of AD with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers.
AI Summary
Eli Lilly and Company announced that the European Commission has granted marketing authorization for Kisunla (donanemab) to treat adults in the earliest symptomatic stages of Alzheimer’s disease. The approval covers patients with mild cognitive impairment or mild dementia due to Alzheimer’s, provided they have confirmed amyloid plaque buildup and are either apolipoprotein E (ApoE4) heterozygotes or non-carriers.
In the Phase 3 TRAILBLAZER-ALZ 2 study, Kisunla significantly slowed both cognitive and functional decline over 18 months. Lilly’s data show that patients treated early experienced the greatest benefits, preserving memory and everyday skills for longer periods.
Kisunla is the only once-monthly infusion therapy backed by evidence supporting treatment completion once amyloid plaques reach minimal levels. This approach may reduce infusion frequency and overall treatment costs, giving patients more time to focus on daily life and independence.
Read Announcement- Drug:
- Donanemab
- Announced Date:
- July 25, 2025
- Indication:
- Alzheimer's disease (AD)
Announcement
Eli Lilly and Company announced that that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending donanemab for the treatment of early symptomatic Alzheimer's disease in adults with confirmed amyloid pathology who are apolipoprotein E ε4 (ApoE4) heterozygotes or non-carriers.
AI Summary
Eli Lilly announced that EMA’s CHMP issued a positive opinion recommending donanemab for adults with early symptomatic Alzheimer’s, confirmed amyloid pathology, who are ApoE4 heterozygotes or non-carriers. It now goes to the European Commission for a final decision expected in coming months.
This recommendation follows TRAILBLAZER-ALZ 2, which showed donanemab slowed cognitive and functional decline and reduced progression risk, and TRAILBLAZER-ALZ 6, in which a modified dosing schedule cut imaging abnormalities while effectively removing plaques.
Alzheimer’s affects about 6.9 million people in Europe, a figure set to nearly double by 2050. One-third of those with mild impairment advance to the next stage within a year.
Patrik Jonsson, Lilly’s international president, called this opinion “a significant milestone” toward making donanemab available and reaffirmed Lilly’s commitment to further research.
Read Announcement- Drug:
- Donanemab
- Announced Date:
- May 21, 2025
- Indication:
- Alzheimer's disease (AD)
Announcement
Eli Lilly and Company announced that the Australian Therapeutic Goods Administration (TGA) has granted marketing authorization for Kisunla (donanemab), an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in adults who are Apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.
AI Summary
Eli Lilly and Company announced that the Australian Therapeutic Goods Administration (TGA) has granted marketing authorization for Kisunla (donanemab). This new treatment is designed for adults with mild cognitive impairment and mild dementia due to Alzheimer’s disease who are Apolipoprotein E ε4 heterozygotes or non-carriers. The therapy is given as an intravenous infusion every four weeks. Kisunla works by targeting and helping remove the amyloid plaques that build up in the brain, which can slow down cognitive and functional decline in early symptomatic Alzheimer’s patients.
The TGA’s approval is an important milestone for the treatment, reinforcing the evidence from clinical studies that support its use in slowing memory loss and daily function deterioration. With Kisunla now available in Australia, patients and healthcare providers have a new option for early intervention in Alzheimer’s disease treatment.
Read Announcement- Drug:
- Donanemab
- Announced Date:
- July 2, 2024
- Indication:
- Alzheimer's disease (AD)
Announcement
Eli Lilly announced that The U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion)
AI Summary
The U.S. Food and Drug Administration (FDA) approved Eli Lilly’s Kisunla™ (donanemab-azbt, 350 mg/20 mL) as a once-monthly injection for adults with early symptomatic Alzheimer’s disease, including those with mild cognitive impairment or mild dementia. Kisunla is unique because it targets amyloid plaques, the protein clumps linked to memory and thinking problems, and supports a limited-duration treatment approach. Clinical studies showed that Kisunla slowed cognitive and functional decline by up to 35% compared to placebo and reduced the risk of progressing to a more advanced stage of Alzheimer’s by up to 39%.
The treatment involves 30-minute infusions that can lead to a significant reduction in amyloid plaques. Once patients achieve minimal plaque levels on amyloid PET imaging, they may stop treatment, which has the potential to lower costs and reduce the number of infusions required compared to continuous therapies.
Read Announcement
Tirzepatide FDA Regulatory Timeline and Events
Tirzepatide is a drug developed by Eli Lilly and Company for the following indication: For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- tirzepatide
- Announced Date:
- September 17, 2025
- Indication:
- For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Announcement
Eli Lilly and Company announced detailed results from SURPASS-PEDS, the first Phase 3 trial to evaluate the safety and efficacy of Mounjaro (tirzepatide), a GIP/GLP-1 dual receptor agonist, in children and adolescents (ages 10 to less than 18) with type 2 diabetes inadequately controlled with metformin, basal insulin or both.
AI Summary
Eli Lilly’s SURPASS-PEDS trial is the first Phase 3 study testing Mounjaro (tirzepatide) in young people 10 to under 18 years old with type 2 diabetes that wasn’t well controlled by metformin, basal insulin, or both. A total of 99 participants were randomized to receive once-weekly Mounjaro (5 mg or 10 mg) or placebo for 30 weeks, followed by a 22-week open-label extension.
At 30 weeks, pooled doses of Mounjaro met the primary endpoint, reducing average A1C by 2.2% versus 0.05% for placebo. In the 10 mg group, 86.1% of teens achieved an A1C of ≤ 6.5%. Mounjaro also cut BMI by 11.2% on average, compared to a 0.4% decrease with placebo. Improvements in blood sugar and BMI continued through the 52-week extension.
The safety and tolerability profile in children and adolescents matched what was seen in adults. Most side effects were mild-to-moderate gastrointestinal events during dose escalation. No new safety concerns or severe hypoglycemia episodes were reported.
Read Announcement- Drug:
- tirzepatide
- Announced Date:
- July 31, 2025
- Indication:
- For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Announcement
Eli Lilly Announced Topline Results From SURPASS-CVOT Head-to-head Phase 3 Trial Comparing Mounjaro (Tirzepatide) To Trulicity (Dulaglutide), Mounjaro Achieved The Primary Objective By Demonstrating A Non-inferior Rate Of Major Adverse Cardiovascular Events, Including Cardiovascular Death, Heart Attack Or Stroke Vs. Trulicity
AI Summary
Eli Lilly announced topline results from SURPASS-CVOT, the first head-to-head Phase 3 trial comparing Mounjaro (tirzepatide) to Trulicity (dulaglutide) in adults with type 2 diabetes and cardiovascular disease.
Mounjaro met the primary endpoint by showing a non-inferior rate of major adverse cardiovascular events (MACE-3) and achieved an 8% lower risk of cardiovascular death, heart attack, or stroke versus Trulicity.
The trial enrolled over 13,000 participants across 30 countries and lasted more than four and a half years, making it the largest and longest tirzepatide study to date.
Additional findings included a 16% lower rate of all-cause death with Mounjaro, along with greater reductions in A1C, body weight, and slower kidney function decline compared to Trulicity.
Both drugs maintained their known safety profiles, with mostly mild-to-moderate gastrointestinal events, and detailed results will be submitted to global regulators and published later this year.
Read Announcement- Drug:
- tirzepatide
- Announced Date:
- June 16, 2025
- Indication:
- For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Announcement
Eli Lilly and Company announced that the highest approved doses of Zepbound (tirzepatide)—12.5 mg and 15 mg—will soon be available in single-dose vials for $499 per month through LillyDirect's Self Pay Pharmacy Solutions and the Zepbound Self Pay Journey Program.1
AI Summary
Eli Lilly and Company announced that the highest approved doses of Zepbound (tirzepatide)—12.5 mg and 15 mg—will soon be offered as single-dose vials for $499 per month through LillyDirect’s Self Pay Pharmacy Solutions and the Zepbound Self Pay Journey Program. Starting July 7, healthcare providers can prescribe these doses, and patients will begin receiving shipments in early August. This offer allows eligible adults with obesity and a valid prescription to access any strength of Zepbound vial at $499 per month or less, with the 2.5 mg starter dose priced at $349 per month.
Lilly emphasizes the urgency of treating obesity as a chronic disease, noting that providing self-pay options expands patient access while the company works to broaden overall coverage for Zepbound. This initiative offers another treatment option for those seeking help to manage obesity and related health conditions.
Read Announcement- Drug:
- tirzepatide
- Announced Date:
- May 11, 2025
- Indication:
- For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Announcement
Eli Lilly and Company announced detailed results from SURMOUNT-5, a Phase 3b open-label clinical trial, evaluating the safety and efficacy of Zepbound (tirzepatide), a dual GIP and GLP-1 receptor agonist, compared to Wegovy (semaglutide), a mono GLP-1 receptor agonist, in adults living with obesity, or overweight with at least one weight-related medical problem and without diabetes.
AI Summary
Eli Lilly announced detailed results from SURMOUNT-5, a Phase 3b open‐label trial comparing Zepbound (tirzepatide) with Wegovy (semaglutide) in adults with obesity—or those overweight with at least one weight-related condition—and without diabetes. In this study, participants receiving Zepbound achieved an average weight loss of 20.2% over 72 weeks, compared to 13.7% among those on Wegovy, demonstrating a 47% greater relative reduction. Additionally, Zepbound led to superior outcomes across all secondary endpoints; more participants reached higher weight loss targets, including at least 15% reduction, and experienced greater reductions in waist circumference. The trial’s findings suggest that the dual GIP and GLP-1 receptor agonist, Zepbound, might offer an effective obesity management option with an acceptable safety profile, marking an important advancement in treatment strategies for obesity care.
Read Announcement- Drug:
- tirzepatide
- Announced Date:
- December 20, 2024
- Indication:
- For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Announcement
Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) approved Zepbound® (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity.1
AI Summary
Eli Lilly and Company announced that the FDA has approved Zepbound® (tirzepatide) as the first and only prescription medicine specifically for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Clinical trials showed that patients using Zepbound experienced significant improvements, including at least 25 fewer breathing interruptions per hour and weight loss of up to 20% from their initial body weight. Many participants even saw their OSA symptoms resolve to the point that they no longer experienced breathing disturbances during sleep. This new treatment is designed to be used alongside a reduced-calorie diet and increased physical activity, offering a dual approach by addressing both the sleep disorder and obesity. Healthcare providers are encouraged to consider Zepbound as a valuable option for patients whose OSA is linked to weight issues, potentially leading to more effective management of these interconnected conditions.
Read Announcement- Drug:
- tirzepatide
- Announced Date:
- December 18, 2024
- Indication:
- For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Announcement
Gan & Lee Pharmaceuticals is pleased to announce that the Food and Drug Administration (" FDA ") has cleared the Investigational New Drug (IND) application for GZR18 Injection to conduct a phase 2 clinical trial, a head-to-head with Tirzepatide from Eli Lilly and Company
AI Summary
Gan & Lee Pharmaceuticals announced that the FDA has approved the Investigational New Drug (IND) application for its GZR18 Injection. This clearance allows the company to begin a phase 2 clinical trial in the United States. The study will be a head-to-head comparison with Eli Lilly and Company’s Tirzepatide, aiming to evaluate the effectiveness of GZR18 for chronic weight management in overweight or obese patients, including those with type 2 diabetes. GZR18, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, is designed to delay gastric emptying, enhance satiety, and suppress appetite, potentially offering a flexible, bi-weekly treatment option for maintaining long-term weight loss. The clinical trial will provide crucial data on the effectiveness and safety of GZR18 compared to established treatments, marking a significant step forward in developing innovative therapies for weight management.
Read Announcement- Drug:
- tirzepatide
- Announced Date:
- December 4, 2024
- Indication:
- For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Announcement
Eli Lilly and Company announced topline results from the SURMOUNT-5 phase 3b open-label randomized clinical trial. Zepbound® (tirzepatide) provided a 47% greater relative weight loss compared to Wegovy® (semaglutide).
AI Summary
Eli Lilly and Company announced topline results from the SURMOUNT-5 phase 3b open-label randomized clinical trial, which compared Zepbound (tirzepatide) with Wegovy (semaglutide) in adults with obesity or overweight who have at least one weight-related medical condition and do not have diabetes. The trial demonstrated that patients treated with Zepbound experienced a 47% greater relative weight loss, with an average body weight reduction of 20.2%, compared to 13.7% for those on Wegovy. In addition, a higher percentage of participants on Zepbound reached significant weight loss milestones, highlighting its effectiveness in managing obesity. The study’s results provide important information for healthcare providers and patients when choosing an obesity treatment, as Zepbound’s dual GIP and GLP-1 receptor agonist action set it apart from other treatment options.
Read Announcement- Drug:
- tirzepatide
- Announced Date:
- August 27, 2024
- Indication:
- For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Announcement
Eli Lilly and Company announced Zepbound® (tirzepatide) 2.5 mg and 5 mg single-dose vials are available for self-pay for patients with an on-label prescription, significantly expanding the supply of Zepbound in response to high demand.
AI Summary
Eli Lilly and Company has expanded access to Zepbound® (tirzepatide) by offering 2.5 mg and 5 mg single-dose vials through its LillyDirect® self-pay channel for patients with an on-label prescription. These vials are available at a minimum 50% discount compared to the list price of other incretin medicines for obesity. This initiative is designed to address the high demand for Zepbound and help patients who lack insurance coverage or eligibility for the savings program, affording them a cost-effective and genuine option.
The self-pay channel simplifies the purchase process by eliminating third-party supply chain markups, ensuring that patients receive the authentic medicine directly from Lilly. By expanding the supply and transparent pricing, Lilly aims to make obesity treatment more accessible for millions of patients in need of safe and effective therapy.
Read Announcement- Drug:
- tirzepatide
- Announced Date:
- August 20, 2024
- Indication:
- For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Announcement
Eli Lilly and Company announced positive topline results from the SURMOUNT-1 three-year study (176-week treatment period) evaluating the efficacy and safety of tirzepatide (Zepbound® and Mounjaro®) once weekly for long-term weight management and delay in progression to diabetes in adults with pre-diabetes and obesity or overweight.
AI Summary
Eli Lilly and Company announced positive topline results from the SURMOUNT-1 three-year study, which evaluated tirzepatide (marketed as Zepbound® and Mounjaro®) for long-term weight management and delaying type 2 diabetes in adults with pre-diabetes who are obese or overweight. In the 176-week study, patients receiving the 15 mg dose of tirzepatide experienced a 22.9% average weight loss, compared to only 2.1% in the placebo group. Additionally, tirzepatide reduced the risk of progressing to type 2 diabetes by up to 94% compared to placebo. The study highlights the potential of tirzepatide’s dual action as a GIP and GLP-1 receptor agonist—helping to regulate appetite and stimulate insulin secretion—to provide sustained benefits in weight loss and diabetes prevention over a long-term treatment period.
Read Announcement- Drug:
- tirzepatide
- Announced Date:
- August 1, 2024
- Indication:
- For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Announcement
Eli Lilly and Company announced positive topline results from the SUMMIT phase 3 clinical trial evaluating the safety and efficacy of tirzepatide injection (5 mg, 10 mg or 15 mg) in adults with heart failure with preserved ejection fraction (HFpEF) and obesity.
AI Summary
Eli Lilly’s SUMMIT phase 3 trial showed promising results for tirzepatide in adults with heart failure with preserved ejection fraction (HFpEF) and obesity. Tested in doses of 5 mg, 10 mg, and 15 mg, the study reported a 38% reduction in the risk of heart failure outcomes, including urgent visits, hospitalizations, and cardiovascular death, compared to a placebo. Participants also experienced significant improvements in heart failure symptoms and physical limitations, as well as better exercise capacity. Notably, tirzepatide led to a substantial mean body weight reduction of around 15.7% from baseline.
These findings highlight tirzepatide’s potential as a new treatment option to address the limited therapies available for the nearly half of heart failure patients who also face obesity. Lilly plans to present the complete data at an upcoming medical meeting and submit the results to the FDA and other regulatory agencies later this year.
Read Announcement- Drug:
- tirzepatide
- Announced Date:
- June 21, 2024
- Indication:
- For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Announcement
Eli Lilly and Company announced detailed results from the SURMOUNT-OSA phase 3 clinical trials evaluating tirzepatide injection (10 mg or 15 mg) for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity, with and without positive airway pressure (PAP) therapy.
AI Summary
Eli Lilly and Company announced promising results from the SURMOUNT-OSA phase 3 clinical trials, which evaluated tirzepatide injections (10 mg and 15 mg) for treating moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. The trials included participants both with and without positive airway pressure (PAP) therapy. Tirzepatide significantly reduced OSA severity by up to 62.8%, resulting in roughly 30 fewer apnea events each hour compared to placebo. In a key secondary outcome, about 43% and 51.5% of patients on the highest dose achieved disease resolution based on specific criteria for the apnea-hypopnea index and the Epworth Sleepiness Scale. These results suggest that tirzepatide may offer a new treatment option for addressing the underlying causes of OSA in obese patients, potentially reducing reliance on PAP therapy and improving overall health outcomes.
Read Announcement- Drug:
- tirzepatide
- Announced Date:
- June 8, 2024
- Indication:
- For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Announcement
Eli Lilly and Company announced detailed results from SYNERGY-NASH, a phase 2 study of 190 patients, with or without type 2 diabetes, to evaluate the investigational use of tirzepatide in adults with biopsy-proven metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis.
AI Summary
Eli Lilly and Company announced results from SYNERGY-NASH, a phase 2 study that looked at 190 patients with metabolic dysfunction-associated steatohepatitis (MASH) and stage 2 or 3 fibrosis. The study tested tirzepatide in adults, both with and without type 2 diabetes. After 52 weeks of treatment, the study’s primary endpoint was reached: 51.8%, 62.8%, and 73.3% of patients taking 5 mg, 10 mg, and 15 mg of tirzepatide, respectively, showed MASH resolution without worsening fibrosis, compared to only 13.2% on placebo.
The trial also showed improvements in fibrosis, body weight, and various blood markers related to liver injury and inflammation. These positive findings suggest that tirzepatide may offer a promising new treatment option for people dealing with MASH, a condition that is a growing burden on liver health in the United States.
Read Announcement
Olomorasib FDA Regulatory Events
Olomorasib is a drug developed by Eli Lilly and Company for the following indication: for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- olomorasib
- Announced Date:
- September 4, 2025
- Indication:
- for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers
Announcement
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib, in combination with anti-PD-1 therapy KEYTRUDA (pembrolizumab), for the first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression ≥ 50%, as determined by FDA approved tests.
AI Summary
Eli Lilly announced that the FDA granted Breakthrough Therapy designation to olomorasib combined with KEYTRUDA for first-line treatment of unresectable advanced or metastatic non-small cell lung cancer in patients with KRAS G12C mutations and PD-L1 expression ≥50%, as determined by FDA-approved tests. This designation aims to expedite development and review of drugs that may offer substantial improvement over existing therapies.
The decision is based on encouraging data from the Phase 1/2 LOXO-RAS-20001 trial and the dose optimization portion of the Phase 3 SUNRAY-01 trial. Olomorasib is a potent, highly selective KRAS G12C inhibitor with preliminary evidence of central nervous system activity. Updated efficacy and safety results will be presented at the IASLC 2025 World Conference on Lung Cancer in Barcelona. This step highlights the urgent need for better first-line options in this high-PD-L1 patient population.
Read Announcement
Donanemab-azbt FDA Regulatory Events
Donanemab-azbt is a drug developed by Eli Lilly and Company for the following indication: In early symptomatic Alzheimer's disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- donanemab-azbt
- Announced Date:
- July 30, 2025
- Indication:
- In early symptomatic Alzheimer's disease
Announcement
Eli Lilly and Company announced results from the long-term extension (LTE) of the Phase 3 TRAILBLAZER-ALZ 2 study showing that participants treated with Kisunla (donanemab-azbt) demonstrated slowing of decline, a benefit that continued to grow over three years compared to an untreated external cohort from the Alzheimer's Disease Neuroimaging Initiative (ADNI).1
AI Summary
Results from the long-term extension (LTE) of the Phase 3 TRAILBLAZER-ALZ 2 study showed that Kisunla (donanemab-azbt) slowed cognitive decline over three years compared to an untreated external cohort from ADNI. Patients treated with Kisunla saw a reduction of –0.6 points on the Clinical Dementia Rating Sum of Boxes (CDR-SB) at 18 months and –1.2 points at 36 months versus ADNI. Early treatment cut the risk of progressing to the next disease stage by 27% compared to those who started later. More than 75% of participants reached amyloid plaque clearance within 76 weeks, and plaque reaccumulation remained slow at about 2.4 Centiloids per year after treatment stopped.
The data underscore the value of early intervention and support a limited-duration dosing approach. No new safety issues emerged, and the benefit continued to grow, reinforcing the long-term value of Kisunla treatment for early Alzheimer’s disease.
Read Announcement
Kisunla FDA Regulatory Events
Kisunla is a drug developed by Eli Lilly and Company for the following indication: For the Treatment of Early Symptomatic Alzheimer's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Kisunla
- Announced Date:
- July 9, 2025
- Indication:
- For the Treatment of Early Symptomatic Alzheimer's Disease
Announcement
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla (donanemab-azbt), Lilly's once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people in the mild dementia stage of AD, with confirmed amyloid pathology.
AI Summary
Eli Lilly and Company announced that the FDA approved a label update for Kisunla (donanemab-azbt), their once-monthly Alzheimer’s therapy for adults with early symptomatic Alzheimer’s disease. The update includes a new recommended titration dosing schedule that shifts a single vial from the first dose to the third dose, allowing the same total amount by week 24.
This modified dosing schedule was shown in the TRAILBLAZER-ALZ 6 study to significantly lower the risk of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) by 41% at 24 weeks and 35% at 52 weeks compared to the original regimen. Importantly, this change maintains Kisunla’s ability to reduce amyloid plaque and levels of disease biomarkers, offering healthcare professionals a safer option for patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease.
Read Announcement- Drug:
- Kisunla
- Announced Date:
- September 24, 2024
- Indication:
- For the Treatment of Early Symptomatic Alzheimer's Disease
Announcement
Eli Lilly and Company announced that The Ministry of Health, Labour and Welfare Japan has approved Kisunla™ (donanemab-azbt, 350 mg/20 mL every four weeks injection for IV infusion) Alzheimer's treatment for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology.
AI Summary
Eli Lilly and Company announced that Japan’s Ministry of Health, Labour and Welfare has approved Kisunla™ (donanemab-azbt, 350 mg/20 mL administered via IV infusion every four weeks) for adults with early symptomatic Alzheimer’s disease. This treatment is designed for patients with mild cognitive impairment (MCI) as well as those in the mild dementia stage of Alzheimer’s disease, provided they have confirmed amyloid pathology. The approval is timely given Japan’s rapidly aging population and an expected increase in dementia cases, with over 5 million patients projected by 2030 and Alzheimer’s being the most common cause. This milestone approval highlights the promising clinical trial results demonstrating that Kisunla helps slow cognitive and functional decline by reducing amyloid plaques in the brain, offering a new hope for patients and families affected by early Alzheimer’s disease.
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Efsitora alfa FDA Regulatory Timeline and Events
Efsitora alfa is a drug developed by Eli Lilly and Company for the following indication: In adults with type 2 diabetes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- efsitora alfa
- Announced Date:
- June 22, 2025
- Indication:
- In adults with type 2 diabetes
Announcement
Eli Lilly and Company announced detailed results from QWINT-1, QWINT-3, and QWINT-4 Phase 3 clinical trials evaluating the safety and efficacy of investigational once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes who used insulin for the first time, previously used daily basal insulin, and previously used daily basal insulin and mealtime insulin, respectively.
AI Summary
Eli Lilly announced detailed results from three Phase 3 trials – QWINT-1, QWINT-3, and QWINT-4 – that evaluated the safety and effectiveness of their once‐weekly insulin efsitora alfa in adults with type 2 diabetes. Each trial focused on different patient groups: those new to insulin, those previously using daily basal insulin, and those using both basal and mealtime insulin.
In all three studies, efsitora met its primary goal by showing non-inferior A1C reductions compared to daily insulin. Notably, QWINT-1 used a novel fixed-dose regimen with four set titration levels over 52 weeks, suggesting that a simplified, once-weekly dosing approach could ease insulin initiation. QWINT-3 and QWINT-4 further supported these findings over 26 weeks by demonstrating comparable glycemic control against established daily therapies.
Read Announcement- Drug:
- efsitora alfa
- Announced Date:
- May 29, 2025
- Indication:
- In adults with type 2 diabetes
Announcement
Eli Lilly and Company announced that data from studies of orforglipron, insulin efsitora alfa, tirzepatide (Zepbound and Mounjaro), retatrutide, eloralintide and bimagrumab will be presented at the American Diabetes Association's (ADA) 85th Scientific Sessions taking place June 20-23 in Chicago.
AI Summary
Eli Lilly and Company announced that it will present data from several key studies at the upcoming American Diabetes Association’s 85th Scientific Sessions in Chicago from June 20–23. The presentations will cover a range of promising treatments including orforglipron, insulin efsitora alfa, tirzepatide (marketed as both Zepbound and Mounjaro), retatrutide, eloralintide, and bimagrumab. These studies target conditions such as type 2 diabetes, obesity, and other cardiometabolic disorders by evaluating the safety and efficacy of these novel therapies. In addition to the clinical data sessions at the ADA event, Lilly will also host an investor event on June 22 via live webcast, where the company’s cardiometabolic portfolio and key findings from these trials will be discussed. This initiative highlights Lilly’s commitment to advancing innovative treatments in metabolic health.
Read Announcement- Drug:
- efsitora alfa
- Announced Date:
- September 5, 2024
- Indication:
- In adults with type 2 diabetes
Announcement
Eli Lilly and Company announced positive topline results from the QWINT-1 and QWINT-3 phase 3 clinical trials evaluating once weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes using basal insulin for the first time (insulin naïve) and in those who have switched from daily basal insulin injections, respectively.
AI Summary
Eli Lilly and Company recently announced positive topline results from two phase 3 clinical trials, QWINT-1 and QWINT-3, evaluating their once-weekly insulin efsitora alfa (efsitora). The QWINT-1 trial focused on adults with type 2 diabetes who were insulin naïve, meaning they had not previously used basal insulin. In this study, efsitora, administered via a single-use autoinjector with four fixed weekly doses, achieved an A1C reduction similar to that of daily insulin glargine over 52 weeks. Meanwhile, the QWINT-3 trial involved participants switching from daily basal insulin injections. Efsitora showed non-inferior A1C lowering compared to daily insulin degludec over a 26-week period. These results suggest that efsitora could simplify the management of type 2 diabetes by reducing the frequency of injections while maintaining effective blood glucose control.
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LY4050784 FDA Regulatory Events
LY4050784 is a drug developed by Eli Lilly and Company for the following indication: pan-KRAS inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LY4050784
- Announced Date:
- March 25, 2025
- Indication:
- pan-KRAS inhibitor
Announcement
Eli Lilly and Company announced that preclinical data for agents targeting SMARCA2 (BRM) and multiple KRAS mutations will be presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25 - 30 in Chicago.
AI Summary
Eli Lilly and Company announced it will share new preclinical data at the American Association for Cancer Research Annual Meeting in Chicago from April 25 to 30. The company is showcasing results on two experimental agents that target challenging cancer mutations. One study focuses on LY4050784, a selective inhibitor of SMARCA2 (BRM), tested in combination with chemotherapy, pembrolizumab, and KRAS inhibitors in models of SMARCA4 mutant cancers. Another study will highlight LY4066434, an oral pan-KRAS inhibitor with strong selectivity over HRAS and NRAS mutations, which has shown robust anti-tumor activity in KRAS-mutant models, including those affecting the central nervous system. Both programs are advancing through Phase 1 studies. These presentations, organized in oral sessions led by experts including Nathan Brooks and Hong Gao, underline Eli Lilly’s ongoing effort to improve cancer treatments through modern targeted therapies and innovative clinical research.
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Mirikizumab FDA Regulatory Events
Mirikizumab is a drug developed by Eli Lilly and Company for the following indication: Moderate to severe ulcerative colitis (UC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- mirikizumab
- Announced Date:
- December 13, 2024
- Indication:
- Moderate to severe ulcerative colitis (UC)
Announcement
Eli Lilly and Company announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Omvoh® (mirikizumab), an interleukin-23p19 (IL-23p19) antagonist, for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
AI Summary
Eli Lilly and Company announced that the European Medicines Agency’s CHMP has issued a positive opinion for Omvoh® (mirikizumab), an interleukin‐23p19 antagonist. This treatment is aimed at adults with moderately to severely active Crohn’s disease who have not responded adequately to conventional treatments or biologics. The positive opinion is based on results from the Phase 3 VIVID-1 trial, which demonstrated significant improvements in clinical remission and endoscopic response, in addition to relieving disruptive symptoms such as bowel urgency. Omvoh also showed benefits in reducing inflammation as seen in strict histologic measures. The approval by the European Commission is expected in the next one to two months, marking a major step forward in providing a new treatment option for patients who struggle with managing their Crohn’s disease.
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Lebrikizumab FDA Regulatory Events
Lebrikizumab is a drug developed by Eli Lilly and Company for the following indication: Atopic dermatitis (AD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lebrikizumab
- Announced Date:
- September 13, 2024
- Indication:
- Atopic dermatitis (AD)
Announcement
Eli Lilly And Co announced that FDA Approval For Eczema Treatment Ebglyss
AI Summary
Eli Lilly and Company announced that the FDA approved EBGLYSS (lebrikizumab-lbkz) as a new first-line biologic treatment for moderate-to-severe atopic dermatitis. This treatment is now available for adults and children aged 12 and older who weigh at least 88 pounds and whose eczema is not well controlled by topical therapies.
EBGLYSS works by targeting the IL-13 protein, a key driver of eczema inflammation. In clinical trials, patients saw significant skin clearance as early as four weeks and experienced meaningful itch relief within two weeks. After the initial doses, patients move to a convenient monthly maintenance injection, which has shown long-lasting effectiveness for up to one year. This FDA approval offers a promising new option for individuals struggling with persistent eczema symptoms, ultimately improving their quality of life.
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