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
Donanemab, EBGLYSS, efsitora, Imlunestrant, Kisunla, Lebrikizumab, and LY4050784. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- 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
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 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
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.
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:
- 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
Kisunla - FDA Regulatory Timeline and 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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Lebrikizumab - FDA Regulatory Timeline and 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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LY4050784 - FDA Regulatory Timeline and 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 Timeline and 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.
Read Announcement- Drug:
- mirikizumab
- Announced Date:
- May 21, 2024
- Indication:
- Moderate to severe ulcerative colitis (UC)
Announcement
Eli Lilly and Company' pivotal Phase 3 VIVID-1 study, patients with moderately to severely active Crohn's disease, with or without previous biologic failure, achieved statistically significant and clinically meaningful improvements across multiple clinical and endoscopic endpoints at one year with mirikizumab compared to placebo. Data from this study – the first Phase 3 treat-through data reported for an IL23p19 antibody – will be presented at Digestive Disease Week® (DDW), held in Washington, D.C. from May 18-21.
AI Summary
Eli Lilly’s pivotal Phase 3 VIVID-1 study shows that mirikizumab led to statistically significant and clinically meaningful improvements in patients with moderately to severely active Crohn’s disease. In the study, which included patients with or without previous biologic failure, nearly half achieved an endoscopic response at 52 weeks while a high percentage reached clinical remission. This is especially notable since patients who had experienced prior biologic failure are typically harder to treat. The data, representing the first Phase 3 treat-through results for an IL23p19 antibody, underscore the potential of mirikizumab in addressing both clinical and endoscopic endpoints, with a large number of patients experiencing benefits on both fronts. These findings will be presented at Digestive Disease Week® (DDW) in Washington, D.C. from May 18-21, highlighting the promising future of mirikizumab as a treatment option for Crohn’s disease.
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:
- 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.
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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:
- 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.
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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:
- 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- Drug:
- tirzepatide
- Announced Date:
- April 17, 2024
- Indication:
- For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Announcement
Eli Lilly and Company announced positive topline results of the SURMOUNT-OSA phase 3 clinical trials that showed tirzepatide injection (10 mg or 15 mg) significantly reduced the apnea-hypopnea index (AHI) compared to placebo, achieving the primary endpoints.
AI Summary
Eli Lilly and Company announced positive topline results from their SURMOUNT-OSA phase 3 clinical trials. The trials showed that tirzepatide injection (administered at 10 mg or 15 mg doses once weekly) significantly reduced the apnea-hypopnea index (AHI) compared to placebo. In the studies, patients receiving tirzepatide experienced a reduction in AHI of up to 63%, with about 30 fewer breathing-related events per hour, meeting the primary endpoints of the trials.
These promising results indicate that tirzepatide can meaningfully improve symptoms of moderate-to-severe obstructive sleep apnea in patients with obesity. The significant reduction in AHI supports its potential as a treatment option for addressing the underlying disease. Based on these outcomes, Lilly plans to submit the data for regulatory review worldwide, aiming to bring a novel pharmaceutical treatment approach to sleep apnea management.
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:
- 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
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