Lexicon Pharmaceuticals Announces Submission of Additional Data to U.S. FDA Supporting the Benefit-Risk Profile of Zynquista® in Type 1 Diabetes
Rhea-AI Summary
Lexicon Pharmaceuticals (NASDAQ:LXRX) has submitted additional clinical data to the FDA supporting the potential resubmission of Zynquista's New Drug Application (NDA). The submission aims to address concerns raised in a December 2024 complete response letter regarding increased diabetic ketoacidosis risk in type 1 diabetes patients.
The new data comes from three ongoing third-party funded, investigator-initiated studies conducted by Steno Diabetes Center, Joslin Diabetes Center, and the University of Dundee. The company has been granted a Type D meeting with the FDA, with feedback expected by the end of September 2025.
Positive
- Additional clinical data from three prestigious research centers supporting Zynquista's benefit-risk profile
- Strong patient advocacy support for the drug's approval
- FDA granted Type D meeting to discuss potential regulatory path forward
Negative
- FDA previously rejected Zynquista due to diabetic ketoacidosis risk concerns
- Company is no longer investing in clinical programs for Zynquista
- Uncertain regulatory outcome despite additional data submission
Insights
Lexicon seeks FDA pathway for previously rejected T1D drug Zynquista by submitting new third-party data addressing safety concerns.
Lexicon Pharmaceuticals is making a strategic regulatory move to resurrect its diabetes drug Zynquista (sotagliflozin) by submitting additional clinical data from third-party studies to address the FDA's concerns about diabetic ketoacidosis (DKA) risk. This follows a Complete Response Letter (CRL) issued in December 2024 that effectively rejected the company's New Drug Application.
The company has secured a Type D meeting with the FDA, which is specifically designed for focused discussions on a narrow set of issues. This meeting format suggests Lexicon is attempting to address very specific safety concerns rather than conducting extensive new trials. The FDA's feedback is expected by the end of September.
What's particularly noteworthy is that the submitted data comes from three independent, investigator-initiated studies from prestigious diabetes research centers: Steno Diabetes Center, Joslin Diabetes Center, and University of Dundee. Using third-party data is a cost-effective strategy since Lexicon explicitly states they are "no longer investing in clinical programs for Zynquista" - indicating they're unwilling to fund additional company-sponsored trials but still see potential value in the asset.
The dual SGLT1/SGLT2 inhibition mechanism of Zynquista differentiates it from currently approved SGLT2-only inhibitors. While the press release mentions "outpouring of patient support," this suggests Lexicon may be leveraging patient advocacy as part of their regulatory strategy, though the ultimate decision will hinge on the scientific evidence regarding safety.
Data obtained from ongoing third-party funded, investigator-sponsored trials have been submitted in effort to address the December 2024 complete response letter
Company seeks alignment on reasonable path forward for Zynquista NDA resubmission
FDA feedback from Type D meeting expected by end of September
THE WOODLANDS, Texas, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today 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).
The submission of additional clinical data follows a complete response letter issued by the FDA in December 2024 that cited concerns of increased risk of diabetic ketoacidosis. Based on subsequent discussions with FDA regarding potential regulatory paths forward, Lexicon has been granted a Type D meeting and has submitted data from three ongoing studies of sotagliflozin conducted by the Steno Diabetes Center (STENO1)1, the Joslin Diabetes Center (SUGARNSALT)2 and the University of Dundee (SOPHIST)3 supporting the benefit-risk profile of Zynquista in T1D.
“There has been an outpouring of patient support advocating for the approval of Zynquista in T1D,” said Dr. Mike Exton, Ph.D., chief executive officer and director of Lexicon Pharmaceuticals. “While we are no longer investing in clinical programs for Zynquista, we remain committed to exploring all opportunities to bring this medicine to patients, whose support for approval is unwavering.”
About Sotagliflozin
Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.
References
1“Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes (Steno1).” Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT06082063. Accessed 4 Sept. 2025.
2“Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease (SUGARNSALT).” Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT06217302. Accessed 4 Sept 2025.
3“SOPHIST Clinical Trial.” University of Dundee, www.sites.dundee.ac.uk/sophist-trial/. Accessed 4 Sept. 2025.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates, including sotagliflozin. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, regulatory interactions relating to its drug candidates, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
For Investor and Media Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com
FAQ
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