This section highlights FDA-related milestones and regulatory updates for drugs developed by Lexicon Pharmaceuticals (LXRX).
Over the past two years, Lexicon Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LX9211, LX9851, and sotagliflozin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
LX9211 - FDA Regulatory Timeline and Events
LX9211 is a drug developed by Lexicon Pharmaceuticals for the following indication: In Diabetic Peripheral Neuropathic Pain (DPNP).
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:
- LX9211
- Announced Date:
- March 6, 2025
- Indication:
- In Diabetic Peripheral Neuropathic Pain (DPNP)
Announcement
Lexicon Pharmaceuticals, provided an update on key corporate milestones and accomplishments.
AI Summary
Lexicon Pharmaceuticals recently provided an update on its key corporate milestones and accomplishments. The company has repositioned its operations to focus on advancing its research and development pipeline under the "Lead to Succeed" strategy. In 2024, Lexicon highlighted progress on three main programs. The PROGRESS Phase 2b study of pilavapadin in diabetic peripheral neuropathic pain achieved its objectives at a 10 mg dose, showing significant pain reduction compared with placebo and good tolerability. This success is paving the way for a Phase 3 trial in 2025. Additionally, Lexicon is on track for an IND filing later this year for LX9851, a candidate for obesity and related metabolic disorders. They are also enrolling patients in a Phase 3 trial of sotagliflozin for hypertrophic cardiomyopathy. These milestones reflect the company’s renewed focus on developing differentiated therapies to address significant unmet medical needs.
Read Announcement- Drug:
- LX9211
- Announced Date:
- March 3, 2025
- Indication:
- In Diabetic Peripheral Neuropathic Pain (DPNP)
Announcement
Lexicon Pharmaceuticals, Inc announced topline results from the PROGRESS Phase 2b study evaluating pilavapadin (LX9211), an oral, non-opioid investigational adaptor-associated kinase 1 (AAK1) inhibitor in adult patients with moderate to severe diabetic peripheral neuropathic pain (DPNP)..
AI Summary
Lexicon Pharmaceuticals announced positive topline results from the PROGRESS Phase 2b trial evaluating pilavapadin (LX9211), a novel oral non-opioid AAK1 inhibitor for moderate to severe diabetic peripheral neuropathic pain (DPNP). The study met its objectives at the 10 mg dose, which showed meaningful pain reduction compared to placebo while being well-tolerated. Unlike previous trials, the PROGRESS study eliminated the initial loading dose, which helped improve tolerability. Although higher doses did not show a clear benefit over placebo, the 10 mg dose demonstrated early and sustained improvement in pain scores. Based on these findings, Lexicon plans to advance the 10 mg dose into Phase 3 development, supporting its potential as an alternative non-opioid treatment for DPNP. The results offer hope for patients who struggle with inadequate relief from current treatment options.
Read Announcement- Drug:
- LX9211
- Announced Date:
- March 2, 2025
- Indication:
- In Diabetic Peripheral Neuropathic Pain (DPNP)
Announcement
Lexicon Pharmaceuticals, Inc announced the Company will hold a conference call and webcast on Monday, March 3, 2025 at 8:00 a.m. ET to share topline results from the Phase 2b PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study with an Open-label Extension in PatientS with Diabetic Peripheral Neuropathic Pain) study evaluating pilavapadin (LX9211), an oral, non-opioid investigational adaptor-associated kinase 1 (AAK1) inhibitor in adult patients with moderate to severe diabetic peripheral neuropathic pain (DPNP).
AI Summary
Lexicon Pharmaceuticals, Inc. announced a live conference call and webcast to discuss topline results from its Phase 2b PROGRESS study. The study evaluated pilavapadin (LX9211), an oral, non-opioid investigational inhibitor of adaptor-associated kinase 1 (AAK1), in adults suffering from moderate to severe diabetic peripheral neuropathic pain (DPNP). The study design was placebo-controlled and randomized, with participants continuing on their stable DPNP therapies. The conference call is scheduled for Monday, March 3, 2025, at 8:00 a.m. ET (7:00 a.m. CT), and interested parties can access the event via the company’s website. Those wishing to ask questions can register to receive dial-in numbers and a unique pin for participation. An archived version of the webcast will also be available on Lexicon’s website.
Read Announcement- Drug:
- LX9211
- Announced Date:
- January 21, 2025
- Indication:
- In Diabetic Peripheral Neuropathic Pain (DPNP)
Announcement
Lexicon Pharmaceuticals, Inc. announced that the company will host a virtual webcast: "LX9211 - Changing the Paradigm for Treatment of Neuropathic Pain."
AI Summary
Lexicon Pharmaceuticals, Inc. announced that it will host a virtual webcast titled "LX9211 - Changing the Paradigm for Treatment of Neuropathic Pain." The event is scheduled for January 28, 2025, from 9:00 a.m. to 11:00 a.m. ET. During the webcast, Lexicon’s leadership will present an in-depth overview of LX9211, a potential treatment for diabetic peripheral neuropathic pain. Top executives, including CEO Mike Exton, PhD, Vice President Suma Gopinathan, PhD, and Chief Medical Officer Craig Granowitz, MD, PhD, will discuss the innovative approach that LX9211 takes in treating neuropathic pain.
The webcast will also include an expert panel on diabetic peripheral neuropathic pain and a Q&A session, allowing viewers to ask questions and learn more about the treatment. A recording of the webcast will be available on the Lexicon website after the event.
Read Announcement- Drug:
- LX9211
- Announced Date:
- November 26, 2024
- Indication:
- In Diabetic Peripheral Neuropathic Pain (DPNP)
Announcement
Lexicon Pharmaceuticals, Inc. announced the completion of patient enrollment in the PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study with an Open-label Extension in PatientS with Diabetic Peripheral Neuropathic Pain) study evaluating LX9211, a novel, orally-delivered, selective investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1), for the treatment of diabetic peripheral neuropathic pain (DPNP).
AI Summary
Lexicon Pharmaceuticals, Inc. announced that patient enrollment for its Phase 2b PROGRESS study evaluating LX9211 has been successfully completed. The study, focused on treating diabetic peripheral neuropathic pain (DPNP), enrolled 494 patients, which is 20 percent more than originally targeted, and finished enrollment eight weeks ahead of schedule. LX9211 is an investigational, orally delivered small molecule inhibitor of adaptor-associated kinase 1 (AAK1) and is being studied as a novel non-opioid option to manage the symptoms of DPNP.
The strong enrollment and high level of interest in the study underline the urgent need for improved treatment options for patients with DPNP. Lexicon expects top-line data from the PROGRESS study to be announced in the first quarter of 2025, which could have important implications for future Phase 3 trial designs and overall evidence supporting LX9211.
Read Announcement- Drug:
- LX9211
- Announced Date:
- November 26, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 - 2025
- Indication:
- In Diabetic Peripheral Neuropathic Pain (DPNP)
Announcement
Lexicon Pharmaceuticals, Inc. announced that Top-line Data Expected in Q1 2025
AI Summary
Lexicon Pharmaceuticals has reached a key milestone in its Phase 2b PROGRESS study for LX9211, a new, oral investigational drug for diabetic peripheral neuropathic pain. The trial enrolled 494 patients—20% more than planned—and finished recruitment eight weeks ahead of schedule. This robust enrollment is expected to strengthen the study findings and support a well-informed design for future Phase 3 trials.
Significantly, Lexicon announced that top-line data is expected in the first quarter of 2025. These upcoming results are eagerly anticipated as they could provide critical insights into the effectiveness and safety of LX9211, potentially advancing the development of a promising non-opioid treatment option for patients suffering from neuropathic pain related to diabetes.
Read Announcement- Drug:
- LX9211
- Announced Date:
- November 26, 2024
- Indication:
- In Diabetic Peripheral Neuropathic Pain (DPNP)
Announcement
Lexicon Pharmaceuticals, Inc announced the completion of patient enrollment in the PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study with an Open-label Extension in PatientS with Diabetic Peripheral Neuropathic Pain) study evaluating LX9211, a novel, orally-delivered, selective investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1), for the treatment of diabetic peripheral neuropathic pain (DPNP).
AI Summary
Lexicon Pharmaceuticals announced that enrollment for its PROGRESS study evaluating LX9211 in patients with diabetic peripheral neuropathic pain (DPNP) is now complete. The Phase 2b trial, designed as a dose-ranging, randomized, double-blind, and placebo-controlled study, enrolled 494 patients—exceeding its target by 20% and finishing eight weeks ahead of schedule. LX9211 is a novel, orally delivered, selective small molecule inhibitor of the enzyme AAK1, which may offer a promising non-opioid treatment option for DPNP. The study allows participants to maintain one stable-dose therapy, mirroring real-world treatment practices. Top-line data from the trial is expected to be released in the first quarter of 2025, and the larger-than-planned patient population may provide valuable insights into the drug’s effectiveness and optimal dosing for future clinical trials.
Read Announcement
LX9851 - FDA Regulatory Timeline and Events
LX9851 is a drug developed by Lexicon Pharmaceuticals for the following indication: For obesity and weight loss.
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:
- LX9851
- Announced Date:
- March 28, 2025
- Indication:
- For obesity and weight loss
Announcement
Lexicon Pharmaceuticals, Inc announced that it has entered into an exclusive license agreement with Novo Nordisk A/S for LX9851, a first-in-class, oral non-incretin development candidate in obesity and associated metabolic disorders.
AI Summary
Lexicon Pharmaceuticals, Inc. announced an exclusive license deal with Novo Nordisk A/S for its first-in-class oral candidate, LX9851, aimed at treating obesity and related metabolic disorders. Under the agreement, Novo Nordisk has obtained the worldwide rights to develop, manufacture, and commercialize the drug across all indications, while Lexicon will complete the necessary activities to support the Investigational New Drug (IND) application. Novo Nordisk will then take over by filing the IND and managing further development, manufacturing, and commercialization efforts.
The deal includes upfront and milestone payments totaling up to $1 billion for Lexicon, along with tiered royalties on net sales. LX9851 works by inhibiting Acyl-CoA Synthetase 5 (ACSL5), a key enzyme in fat accumulation and energy balance, and may also promote satiety by delaying gastric emptying.
Read Announcement
sotagliflozin - FDA Regulatory Timeline and Events
sotagliflozin is a drug developed by Lexicon Pharmaceuticals for the following indication: INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).
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:
- sotagliflozin
- Announced Date:
- February 18, 2025
- Indication:
- INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).
Announcement
Lexicon Pharmaceuticals, Inc announced The Lancet Diabetes & Endocrinology has published a research paper analyzing the ability of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, to reduce the risks of life-threatening cardiovascular outcomes.
AI Summary
Lexicon Pharmaceuticals announced that a research paper published in The Lancet Diabetes & Endocrinology highlights the unique benefits of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, in reducing life-threatening cardiovascular outcomes. The study, titled “Reduction in Major Adverse Cardiovascular Events with Sotagliflozin: A Prespecified Analysis of the SCORED Randomized Trial,” analyzed data from patients with type 2 diabetes, chronic kidney disease, and high cardiovascular risk. Findings showed that sotagliflozin notably lowered the rate of major adverse cardiovascular events (MACE), including heart attacks and strokes, with a significant reduction compared to placebo. According to leading researchers, sotagliflozin is the only inhibitor in its drug class to demonstrate significant decreases in both myocardial infarction and stroke. These results underscore the potential of sotagliflozin to offer enhanced cardiovascular benefits relative to other SGLT inhibitors.
Read Announcement- Drug:
- sotagliflozin
- Announced Date:
- September 27, 2024
- Indication:
- INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).
Announcement
Lexicon Pharmaceuticals, Inc. announced that it will unveil study design details of SONATA-HCM, the company's Phase 3 clinical trial of sotagliflozin as a potential new treatment for adults with hypertrophic cardiomyopathy (HCM), at the virtual Hypertrophic Cardiomyopathy Medical Society (HCMS) 2024 Scientific Sessions.
AI Summary
Lexicon Pharmaceuticals, Inc. announced it will present details of the SONATA-HCM study design at the upcoming virtual Hypertrophic Cardiomyopathy Medical Society (HCMS) 2024 Scientific Sessions. The Phase 3 clinical trial is evaluating sotagliflozin, a novel dual SGLT1 and SGLT2 inhibitor, as a potential treatment for adults with hypertrophic cardiomyopathy (HCM), treatment being explored for both obstructive and non-obstructive types.
The multinational trial is being conducted at 130 sites in 20 countries, and patient randomization is already underway. The study will assess the drug’s efficacy and safety by looking at improvements in symptoms, physical function, and other patient-reported outcomes. This research is a significant step toward a supplemental new drug application (sNDA) to broaden sotagliflozin’s label for treating HCM, addressing an area of high unmet need in this growing patient population.
Read Announcement- Drug:
- sotagliflozin
- Announced Date:
- September 10, 2024
- Indication:
- INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).
Announcement
Lexicon Pharmaceuticals, Inc announced that data from the SOTA-INS CGM Phase 3 randomized clinical trial demonstrated that once-daily dosing of sotagliflozin 400 mg improved time-in-range (TIR) and several continuous glucose monitoring (CGM) parameters, including glucose variability, in insulin-treated type 2 diabetes (T2D) patients.
AI Summary
Lexicon Pharmaceuticals announced promising results from its SOTA-INS CGM Phase 3 trial in insulin-treated type 2 diabetes patients. The study showed that a once-daily 400 mg dose of sotagliflozin increased the time patients spent with glucose levels between 70-180 mg/dL, a key target for managing diabetes. The treatment also improved several continuous glucose monitoring parameters, including a reduction in glucose variability. These improvements suggest that sotagliflozin could help patients achieve more stable blood sugar levels.
In addition to the 400 mg dose, researchers observed positive trends with a 200 mg dose, although the higher dosage showed more significant benefits. The study supports the potential of dual inhibition of SGLT1 and SGLT2, offering an additional option to improve glycemic control in people with type 2 diabetes. These findings add to the growing evidence for sotagliflozin’s role in enhancing diabetes management.
Read Announcement- Drug:
- sotagliflozin
- Announced Date:
- September 3, 2024
- Indication:
- INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).
Announcement
Lexicon Pharmaceuticals, Inc announced that a post-hoc analysis of Phase 3 data from the SCORED clinical trial demonstrated that INPEFA® (sotagliflozin) reduced the risk of major adverse cardiovascular events (MACE) and heart failure (HF) events across the spectrum of diabetes duration.
AI Summary
Lexicon Pharmaceuticals announced a post-hoc analysis from the Phase 3 SCORED clinical trial showing that INPEFA® (sotagliflozin) significantly reduced the risk of major adverse cardiovascular events (MACE) and heart failure (HF) events in patients with varying durations of diabetes. The study found that all patient groups benefited from the treatment, with particularly strong reductions in HF events among patients with a longer history of diabetes. Researchers controlled for similar baseline HbA1c levels and still observed a clear trend: as diabetes duration increased, the benefit from INPEFA became greater, especially regarding heart failure outcomes.
These findings highlight the potential of INPEFA not only to help manage blood sugar but also to improve heart health in patients with diabetes, providing an important option for those at higher cardiovascular risk.
Read Announcement- Drug:
- sotagliflozin
- Announced Date:
- August 21, 2024
- Indication:
- INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).
Announcement
Lexicon Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) expects to convene a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes
AI Summary
Lexicon Pharmaceuticals announced that the FDA expects to hold an Endocrinologic and Metabolic Drugs Advisory Committee meeting on October 31, 2024. During this meeting, the agency will review Zynquista (sotagliflozin), which is proposed as an adjunct to insulin therapy to help manage blood sugar in adults with type 1 diabetes and chronic kidney disease.
The FDA plans to release the meeting’s background materials to the public two business days in advance. The PDUFA goal date remains set for December 20, 2024, as the agency continues assessing the benefit-risk profile of sotagliflozin. Lexicon expressed its anticipation for presenting detailed evidence that supports the potential of Zynquista to offer improved glycemic control for the targeted patient group.
Read Announcement- Drug:
- sotagliflozin
- Announced Date:
- August 21, 2024
- Estimated Event Date Range:
- December 20, 2024 - December 20, 2024
- Target Action Date:
- December 20, 2024
- Indication:
- INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).
Announcement
Lexicon Pharmaceuticals, Inc
AI Summary
Lexicon Pharmaceuticals, Inc. announced that the FDA will hold an Endocrinologic and Metabolic Drugs Advisory Committee meeting on October 31, 2024, to review ZYNQUISTA™ (sotagliflozin). The drug is being evaluated as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease. The company noted that the PDUFA goal date remains December 20, 2024. Lexicon expressed confidence in the data supporting sotagliflozin’s benefit/risk profile, highlighting evidence gathered in studies that support its safety and effectiveness.
Lexicon is dedicated to transforming patients’ lives by advancing innovative medicines. Their unique genomics platform, Genome5000™, has identified promising protein targets for various diseases. The company continues to work on bringing forward new treatments and expanding its pipeline, aiming to address unmet medical needs in chronic conditions such as type 1 diabetes and chronic kidney disease.
Read Announcement - Drug:
- sotagliflozin
- Announced Date:
- August 13, 2024
- Indication:
- INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).
Announcement
Lexicon Pharmaceuticals, Inc. announced that, following a strategic review of its commercial and pipeline programs, it will refocus resources across the portfolio in support of opportunities where the company believes it can have the greatest impact on patients.
AI Summary
Lexicon Pharmaceuticals recently announced a strategic shift after reviewing its commercial and pipeline programs. The company will refocus resources across its portfolio to support the areas where it can make the greatest impact on patients. As part of this realignment, Lexicon will concentrate its promotional efforts on INPEFA® for heart failure, ensuring that its targeted approach continues to deliver value to the cardiovascular community. At the same time, the company is reallocating resources to prepare for the potential commercial launch of ZYNQUISTA™ to improve glycemic control in adults with type 1 diabetes and chronic kidney disease. This strategy aims not only to optimize patient outcomes but also to increase operational efficiency with expected cost savings of approximately $40 million in 2025.
Read Announcement - Drug:
- sotagliflozin
- Announced Date:
- July 16, 2024
- Indication:
- INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).
Announcement
Lexicon Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of its New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD).
AI Summary
Lexicon Pharmaceuticals announced that the U.S. FDA has acknowledged the resubmission of its New Drug Application (NDA) for Zynquista™ (sotagliflozin). This application is intended for use as an adjunct to insulin therapy to help manage blood sugar in adults with type 1 diabetes and chronic kidney disease (CKD). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2024, for its decision on the drug.
With this step in the process complete, Lexicon is moving ahead with preparations for Zynquista’s launch, which is planned for early 2025. The company expressed confidence in the benefit-risk profile of sotagliflozin and looks forward to adding another innovative treatment option for patients with type 1 diabetes and CKD.
Read Announcement- Drug:
- sotagliflozin
- Announced Date:
- July 16, 2024
- Indication:
- INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).
Announcement
Lexicon Pharmaceuticals, Inc. announced that Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2024.
AI Summary
Lexicon Pharmaceuticals, Inc. announced that the U.S. FDA has accepted its resubmitted New Drug Application for Zynquista™, a medicine aimed at helping adults with type 1 diabetes and chronic kidney disease manage blood sugar. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2024.
This milestone indicates that the FDA's review process is now complete under the PDUFA guidelines, allowing Lexicon to move forward with launch preparations. CEO Dr. Mike Exton expressed confidence in the drug’s favorable benefit/risk profile and noted that this step enables the company to prepare for the product's commercial launch, potentially starting in early 2025, should approval be granted.
Read Announcement- Drug:
- sotagliflozin
- Announced Date:
- July 15, 2024
- Indication:
- INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).
Announcement
Lexicon Pharmaceuticals, Inc announced that the Journal of Managed Care + Specialty Pharmacy (JMCP), the peer-reviewed journal of the Academy of Managed Care Pharmacy, has published a research paper concluding that the use of INPEFA® (sotagliflozin) for the treatment of patients hospitalized for heart failure (HF) and suffering from comorbid diabetes leads to significant positive impact on provider health system financial outcomes, largely due to bonus payments through alternative payment models (APM).
AI Summary
Lexicon Pharmaceuticals, Inc. announced that the Journal of Managed Care + Specialty Pharmacy (JMCP) published a research paper demonstrating that INPEFA® (sotagliflozin) can improve financial outcomes for hospitals treating patients with heart failure and diabetes. The study found that using INPEFA reduces the number of hospital readmissions and emergency department visits, which leads to larger bonus payments for providers participating in alternative payment models (APMs). The models examined included bundled payments, accountable care organizations, and programs aimed at reducing readmission rates. These bonus payments, driven by improved patient outcomes, can lead to significant margins per hospital admission and overall yearly savings for a median-sized U.S. community hospital. This research supports the idea that as more health systems adopt APMs, the benefits of using INPEFA can extend both clinically and financially.
Read Announcement- Drug:
- sotagliflozin
- Announced Date:
- June 21, 2024
- Indication:
- INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).
Announcement
Lexicon Pharmaceuticals, Inc announced that, following multiple interactions with and recent feedback from the U.S. Food and Drug Administration (FDA), it has resubmitted its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in people with type 1 diabetes and chronic kidney disease (CKD).
AI Summary
Lexicon Pharmaceuticals, Inc. has resubmitted its New Drug Application (NDA) for sotagliflozin to the FDA. The drug is being evaluated as an adjunct to insulin therapy to help improve glycemic control in people with type 1 diabetes and chronic kidney disease (CKD). This decision comes after the company engaged in multiple discussions and received recent feedback from the FDA regarding the regulatory path forward. Lexicon’s CEO, Lonnel Coats, expressed confidence in the benefit/risk profile of sotagliflozin, emphasizing that the treatment could offer a much-needed option for patients managing both type 1 diabetes and CKD. The company expects to hear back from the FDA within the next 30 days regarding the action date, and a six-month review period is anticipated, with a potential product launch targeted for early 2025.
Read Announcement- Drug:
- sotagliflozin
- Announced Date:
- June 18, 2024
- Indication:
- INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).
Announcement
Lexicon Pharmaceuticals, Inc. announced that the peer-reviewed Journal of the American College of Cardiology: Heart Failure has published a research paper concluding that INPEFA® (sotagliflozin) is cost-effective for people with diabetes and recent worsening heart failure using commonly accepted willingness-to-pay thresholds.
AI Summary
Lexicon Pharmaceuticals announced that the Journal of the American College of Cardiology: Heart Failure recently published a research paper finding that INPEFA® (sotagliflozin) is cost-effective for patients with diabetes and recent worsening heart failure. The study, conducted from a U.S. healthcare perspective, showed that patients treated with INPEFA experienced a lifetime increase in quality-adjusted life-years compared to a placebo group. The lead author, Dr. William S. Weintraub, stressed that these results support the economic value of INPEFA when using standard willingness-to-pay thresholds. This research adds an important economic dimension to the clinical benefits of sotagliflozin by showing that it not only helps improve patient outcomes but also provides significant financial value for payors and the healthcare system.
Read Announcement
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