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
sotagliflozin, pilavapadin, LX9851, and LX9211. 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.
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:
- June 3, 2026
- 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 present data from clinical studies of sotagliflozin in Type 1 diabetes (T1D) and pilavapadin in diabetic peripheral neuropathic pain (DPNP) at the American Diabetes Association (ADA) 2026 Scientific Sessions, being held June 5-8 in New Orleans, Louisiana.
AI Summary
Lexicon Pharmaceuticals said it will share new clinical data at the ADA 2026 Scientific Sessions, held June 5-8 in New Orleans. The company will present two poster studies on Sunday, June 7, in Poster Hall. One presentation will review pooled results from the inTandem trials of sotagliflozin in adults with type 1 diabetes. The data will look at how well the treatment improves blood sugar levels across different patient groups. The second presentation will cover pilavapadin, a treatment being studied for diabetic peripheral neuropathic pain. This study found that kidney function did not change pilavapadin’s drug levels in a Phase 1, open-label, parallel-group trial. Together, the presentations highlight Lexicon’s ongoing work in diabetes care and pain related to diabetes.
Read Announcement- Drug:
- sotagliflozin
- Announced Date:
- March 24, 2026
- 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 three presentations of sotagliflozin clinical data during the American College of Cardiology (ACC) Annual Meeting. The congress is being held March 28-30 in New Orleans, Louisiana.
AI Summary
Lexicon Pharmaceuticals announced it will present three separate sotagliflozin clinical data presentations at the American College of Cardiology (ACC) Annual Meeting, taking place March 28–30 in New Orleans, Louisiana. The company said the presentations will cover new analyses from its late‑stage clinical work on sotagliflozin in people with cardiometabolic disease.
One highlighted presentation reports results from the Phase 3 SCORED study in people with type 2 diabetes, chronic kidney disease and other cardiovascular risk factors. In a prespecified analysis that grouped patients by baseline body mass index (BMI), sotagliflozin lowered rates of heart failure and major adverse cardiovascular events (MACE) regardless of BMI. The findings suggest the drug’s cardiovascular benefits were consistent across different weight categories and will be detailed at the ACC meeting.Read Announcement
- Drug:
- sotagliflozin
- Announced Date:
- March 11, 2026
- 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 results of a post hoc analysis of clinical data evaluating the impact of kidney function on the long-term efficacy and safety of sotagliflozin on people with type 1 diabetes will be delivered as a short oral presentation tomorrow, March 12, during the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD).
AI Summary
Lexicon Pharmaceuticals announced that results of a post hoc analysis examining how kidney function affects the long-term efficacy and safety of sotagliflozin in people with type 1 diabetes will be presented as a short oral presentation on March 12 at the 19th ATTD conference in Barcelona. The analysis used clinical data from two identically designed trials and assessed outcomes after one year of treatment.
The company reported that sotagliflozin produced improvements in multiple efficacy measures after one year in people with normal kidney function and those with mildly reduced kidney function. The drug also improved cardiometabolic parameters and reduced clinically important hypoglycemia events, a major and potentially life‑threatening risk for people with type 1 diabetes. These findings suggest that kidney function did not prevent benefit from sotagliflozin over the study period.Read Announcement
- Drug:
- sotagliflozin
- Announced Date:
- March 11, 2026
- 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 results of a post hoc analysis of clinical data evaluating the impact of kidney function on the long-term efficacy and safety of sotagliflozin on people with type 1 diabetes will be delivered as a short oral presentation tomorrow, March 12, during the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD).
AI Summary
Lexicon Pharmaceuticals announced that results of a post hoc analysis examining how kidney function affects the long-term efficacy and safety of sotagliflozin in people with type 1 diabetes will be delivered as a short oral presentation on March 12 at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Barcelona. The analysis used clinical data from two identically designed trials to explore outcomes across kidney function groups.
Lexicon reported that after one year, sotagliflozin improved multiple efficacy measures in patients with normal and mildly reduced kidney function. The drug also showed benefits in cardiometabolic parameters and reduced clinically important hypoglycemia events. Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer, said these findings were encouraging given the known impact of kidney function on SGLT inhibitor effects.
Read Announcement- Drug:
- sotagliflozin
- Announced Date:
- December 5, 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 clinical data on adipose tissue distribution in non-diabetic patients treated with sotagliflozin will be presented at the 22nd Global Cardio Vascular Clinical Trialists Forum (CVCT 2025). The conference is being held December 8-10, 2025, at the Mayflower Hotel in Washington, D.C.
AI Summary
Lexicon Pharmaceuticals announced that clinical data on adipose tissue distribution in non‑diabetic patients treated with sotagliflozin will be presented at the 22nd Global Cardio Vascular Clinical Trialists Forum (CVCT 2025), held December 8–10, 2025 at the Mayflower Hotel in Washington, D.C.
The results come from SOTA‑P‑CARDIA, a prospective, randomized, double‑blind, placebo‑controlled trial that exclusively enrolled patients with heart failure with preserved ejection fraction (HFpEF) and was conducted by Mount Sinai Medical Center in New York. The presentation, titled "Effect of sotagliflozin on adipose distribution in non‑diabetic patients with HFpEF," will be given by Juan Jose Badimon, Ph.D., on Monday, December 8 at 10:30 a.m. ET.
Sotagliflozin is an oral dual SGLT1/SGLT2 inhibitor discovered by Lexicon. It has been studied in roughly 20,000 patients across heart failure, diabetes, and chronic kidney disease and is under investigation for hypertrophic cardiomyopathy. Lexicon says these data add evidence of sotagliflozin’s differentiated benefits versus SGLT2 inhibitors.
Read Announcement- Drug:
- sotagliflozin
- Announced Date:
- November 8, 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 that new sotagliflozin clinical data was presented at the AHA Annual Scientific Sessions 2025. The data highlighted benefits observed from sotagliflozin treatment in heart failure patients with preserved ejection fraction (HFpEF), and without diabetes, across a range of measures, including cardiac structure and function, quality of life and functional capacity.
AI Summary
Lexicon Pharmaceuticals reported new clinical data on sotagliflozin presented at the AHA Annual Scientific Sessions 2025 showing benefits for heart failure with preserved ejection fraction (HFpEF) in patients without diabetes. The SOTA P CARDIA trial, led by Dr. Juan J. Badimon, was a prospective, randomized, double‑blind, placebo‑controlled study that enrolled 88 racially diverse participants (70% female). Patients received sotagliflozin or placebo for six months and were assessed on cardiac structure and function, six‑minute walk test distance, and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores.
Treatment with sotagliflozin produced statistically significant improvements in left ventricular mass, diastolic function, six‑minute walk capacity, and KCCQ quality‑of‑life measures. Peak VO2 showed a notable but not statistically significant improvement. Investigators highlighted symptom relief, better functional capacity, and improved cardiac structure as key findings, suggesting sotagliflozin may offer meaningful benefits for HFpEF patients without diabetes.
Read Announcement- Drug:
- sotagliflozin
- Announced Date:
- September 22, 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 an update to the previous submission of additional clinical data to the U.S. Food and Drug Administration (FDA) from ongoing third-party funded, investigator-initiated studies supporting the potential resubmission of the New Drug Application for Zynquista® (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin for glycemic control in adults with type 1 diabetes (T1D).
AI Summary
Lexicon Pharmaceuticals announced it has updated its submission of new data to the FDA from third-party funded, investigator-initiated trials. This data supports a potential resubmission of the NDA for Zynquista, an oral SGLT1/SGLT2 inhibitor added to insulin for better blood sugar control in adults with type 1 diabetes.
The studies include work at Steno Diabetes Center, Joslin Diabetes Center and University of Dundee. Each study is looking closely at how sotagliflozin affects blood sugar and safety when combined with insulin. Lexicon aims to show that the benefits of Zynquista outweigh the risks.
The FDA has told Lexicon it needs more time to review the new data. The agency now expects to give feedback from the September Type D meeting in the fourth quarter. Lexicon and the FDA will use this feedback to plan the next steps for a possible NDA resubmission.
Read Announcement- Drug:
- sotagliflozin
- Announced Date:
- September 8, 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 that the Company has submitted additional clinical data to the U.S. Food and Drug Administration (FDA) from ongoing third-party funded, investigator-initiated studies supporting the potential resubmission of the New Drug Application for Zynquista® (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin for glycemic control in adults with type 1 diabetes (T1D).
AI Summary
Lexicon Pharmaceuticals has sent new clinical data to the U.S. Food and Drug Administration from three ongoing, investigator-initiated studies of Zynquista® (sotagliflozin). These trials—conducted by the Steno Diabetes Center (STENO1), the Joslin Diabetes Center (SUGARNSALT) and the University of Dundee (SOPHIST)—are funded by third parties and explore sotagliflozin as an add-on to insulin for adults with type 1 diabetes.
The company secured a Type D meeting with the FDA to discuss a clear path forward for resubmitting its New Drug Application. Lexicon expects feedback by the end of September. Through this process, the firm aims to demonstrate a favorable benefit-risk profile of Zynquista in type 1 diabetes management.
While Lexicon is no longer investing in late-stage trials, it remains committed to working with regulators and patient advocates to bring Zynquista to those who could benefit from improved blood sugar control.
Read Announcement- 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
- 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 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 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
Pilavapadin FDA Regulatory Timeline and Events
Pilavapadin is a drug developed by Lexicon Pharmaceuticals for the following indication: For the treatment of 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:
- pilavapadin
- Announced Date:
- April 17, 2026
- Indication:
- For the treatment of diabetic peripheral neuropathic pain (DPNP)
Announcement
Lexicon Pharmaceuticals, Inc. announced that results from its PROGRESS Phase 2b study of pilavapadin in diabetic peripheral neuropathic pain (DPNP) supporting the selection of pilavapadin 10 mg as the optimal dose for Phase 3 development will be presented on Wednesday April 22, during the American Academy of Neurology (AAN) Annual Meeting.
AI Summary
Lexicon Pharmaceuticals announced that results from its PROGRESS Phase 2b study of pilavapadin in diabetic peripheral neuropathic pain (DPNP) supporting selection of pilavapadin 10 mg as the optimal dose for Phase 3 development will be presented on Wednesday, April 22, during the American Academy of Neurology Annual Meeting. The oral presentation by Suma Gopinathan, Ph.D., reports that pilavapadin 10 mg produced a meaningful reduction in average pain at Week 8 and showed consistent improvements across other pain measures, findings the company says support advancing the 10 mg dose into Phase 3. Presentation details: "Additional Efficacy Data Support Selection of Pilavapadin 10mg for Phase Three Development in DPNP: Results From PROGRESS" on April 22 at 12:03 p.m. CT (presentation S38.005, Session S38: Pain). Lexicon will also present preclinical spasticity data at AAN, highlighting broader interest in the AAK1 pathway.
Read Announcement- Drug:
- pilavapadin
- Announced Date:
- January 21, 2026
- Indication:
- For the treatment of diabetic peripheral neuropathic pain (DPNP)
Announcement
Lexicon Pharmaceuticals, Inc announced the successful completion of the End-of-Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) for pilavapadin in diabetic peripheral neuropathic pain (DPNP).
AI Summary
Lexicon Pharmaceuticals said it completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration for pilavapadin in diabetic peripheral neuropathic pain (DPNP). The FDA raised no objections to moving pilavapadin into Phase 3. Lexicon plans two placebo-controlled, 12-week, two-arm registrational studies testing a 10 mg once-daily dose versus placebo. The primary goal of the studies will be the change in average daily pain score (ADPS) from baseline to Week 12.
The FDA did not require any unexpected preclinical or clinical studies that would likely delay Phase 3 work. Lexicon’s leadership described the meeting as productive and said it provided the guidance needed to design a robust Phase 3 program. Pilavapadin is an investigational, once-daily oral AAK1 inhibitor being developed as a non‑opioid treatment for neuropathic pain; preclinical data showed central nervous system penetration and reduced pain behavior in models.
Read Announcement- Drug:
- pilavapadin
- Announced Date:
- October 14, 2025
- Indication:
- For the treatment of diabetic peripheral neuropathic pain (DPNP)
Announcement
Lexicon Pharmaceuticals, Inc. announced the Company presented additional clinical data and program updates from its Phase 2 pilavapadin program at the 19th Annual Pain Therapeutics Summit.
AI Summary
Lexicon Pharmaceuticals presented new clinical findings from its Phase 2 pilavapadin program at the 19th Annual Pain Therapeutics Summit. The data built on earlier results from the PROGRESS study in diabetic peripheral neuropathic pain and highlighted the 10 mg once-daily dose as the best candidate for Phase 3 development.
Four key conclusions supported this choice: a clear link between higher pilavapadin levels and pain relief, an average 2-point drop in daily pain scores after 12 weeks, treatment completion rates similar to placebo, and a safety profile matching standard care. Further analyses showed no heart-related side effects or issues in patients with mild to moderate kidney problems.
A pooled review of over 600 patients from the RELIEF-DPN and PROGRESS trials confirmed the robustness of the 10 mg dose and explained why the 20 mg dose underperformed. Lexicon is now moving toward Phase 3 studies and advancing partner discussions to bring pilavapadin closer to patients.
Read Announcement- Drug:
- pilavapadin
- Announced Date:
- September 17, 2025
- Indication:
- For the treatment of diabetic peripheral neuropathic pain (DPNP)
Announcement
Lexicon Pharmaceuticals, Inc announced the presentation of clinical data from the company's Phase 2b PROGRESS study for its investigational, AAK1-inhibitor, pilavapadin, for the treatment of diabetic peripheral neuropathic pain
AI Summary
Lexicon Pharmaceuticals presented data from its Phase 2b PROGRESS study of pilavapadin, an investigational, non-opioid, oral AAK1 inhibitor for diabetic peripheral neuropathic pain (DPNP), at the NEUROdiab and EASD Annual Meetings.
The trial evaluated once-daily pilavapadin doses of 10 mg, 20 mg, or 20 mg for seven days followed by 10 mg, in 496 adult patients with type 1 or type 2 diabetes and moderate to severe DPNP.
Researchers identified the 10 mg dose as the most clinically meaningful. In a post-hoc analysis excluding the 20 mg arm, the 10 mg dose showed nominally significant separation from placebo (p < 0.05) and produced a two-point reduction in average daily pain scores by week 11.
Pilavapadin was well tolerated with minimal discontinuations. Lexicon plans Phase 3 trials to further explore this potential new non-opioid, oral option for DPNP, which affects millions of people with diabetes.
Read Announcement- Drug:
- pilavapadin
- Announced Date:
- September 11, 2025
- Indication:
- For the treatment of diabetic peripheral neuropathic pain (DPNP)
Announcement
Lexicon Pharmaceuticals, Inc. announced the presentation of clinical data for its investigational, AAK1-inhibitor, pilavapadin, for the treatment of diabetic peripheral neuropathic pain (DPNP) at three upcoming medical meetings.
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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 23, 2026
- Indication:
- For obesity and weight loss
Announcement
Lexicon Pharmaceuticals, Inc and Novo Nordisk A/S announced that Novo Nordisk has initiated a Phase 1 study with LX9851, a first-in-class, oral non-incretin development candidate.
AI Summary
Lexicon Pharmaceuticals and Novo Nordisk announced that Novo Nordisk has started a Phase 1 study of LX9851, a first-in-class, oral non-incretin candidate for treating obesity and related metabolic disorders. The study will test single and multiple ascending doses versus placebo in 96 adults with overweight or obesity to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics. The trial is expected to finish in the first quarter of 2027.
Under an exclusive license agreement, Novo Nordisk holds worldwide rights to develop, make, and commercialize LX9851. Lexicon earned a second $10 million milestone payment after initial dosing in the Phase 1 trial and could receive a third $10 million later this year. Overall, Lexicon is eligible for up to $1 billion in upfront and milestone payments, plus tiered royalties on net sales if the drug advances successfully.
Read Announcement- Drug:
- LX9851
- Announced Date:
- December 10, 2025
- Indication:
- For obesity and weight loss
Announcement
Lexicon Pharmaceuticals, Inc announced the publication of preclinical data validating Acyl-CoA Synthetase 5 (ACSL5) as a target for obesity and chronic weight management.
AI Summary
Lexicon Pharmaceuticals published preclinical data in the Journal of the Endocrine Society showing that Acyl‑CoA Synthetase 5 (ACSL5) is a promising target for treating obesity and chronic weight management. The paper, “Acyl‑CoA Synthetase 5 knockout and inhibitors protect against diet‑induced obesity in mice by activating the ileal brake,” reports that mice lacking ACSL5 had lower body fat, triglycerides, total cholesterol and blood glucose while keeping lean mass. When fed a high‑fat diet, these knockout mice resisted weight gain. Oral, potent small‑molecule inhibitors of ACSL5 produced similar metabolic benefits in mice with diet‑induced obesity.
Mechanistic studies linked the effects to activation of the ileal brake, which slowed gastric emptying and reduced food intake. Lexicon’s investigational drug LX9851 is an oral, non‑incretin ACSL5 inhibitor; the company says these results support advancing LX9851 as a potential new option for obesity treatment, alone or in combination with other therapies. Lexicon has licensed LX9851 to Novo Nordisk.
Read Announcement- 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.
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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:
- September 4, 2025
- Indication:
- In Diabetic Peripheral Neuropathic Pain (DPNP)
Announcement
Lexicon Pharmaceuticals, Inc announced that the Company will present new data demonstrating the reduction of neuropathic pain by pilavapadin in preclinical models of chemotherapy-induced peripheral neuropathy (CIPN) and multiple sclerosis (MS) at the 9th International Congress on Neuropathic Pain - (NeuPSIG) 2025.
AI Summary
Lexicon Pharmaceuticals will present new preclinical data at the 9th International Congress on Neuropathic Pain (NeuPSIG) 2025, held September 4–6 in Berlin, Germany. The data show that pilavapadin, a selective AAK1 inhibitor, reduced neuropathic pain behaviors in models of chemotherapy-induced peripheral neuropathy and multiple sclerosis.
The poster, titled “LX9211, a Novel AAK1 Inhibitor, Alleviates Pain in Preclinical Models of Chemotherapy-induced Neuropathic Pain and Multiple Sclerosis,” will be displayed on September 6 from 8:30 a.m. to 6:00 p.m. CEST in the Exhibition Poster Area. Suma Gopinathan, Senior Vice President of Discovery, will present the findings.
These results highlight a new approach to modulating pain signaling by targeting AAK1. According to Gopinathan, the promising findings support the potential of pilavapadin to treat a range of neuropathic pain conditions beyond diabetic peripheral neuropathic pain, building on a strong body of evidence for AAK1 inhibition.
Read Announcement- 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
- Target Action Date:
- Q1 2025
- Estimated Target Date Range:
- January 1, 2025 - March 31, 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- 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.
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