Lexicon Pharmaceuticals Submits Additional Data to U.S. FDA To Support Zynquista® Benefit-Risk Profile In Type 1 Diabetes

Lexicon Pharmaceuticals, Inc. has provided an update regarding its ongoing regulatory efforts with the U.S. Food and Drug Administration (FDA) for Zynquista® (sotagliflozin), an oral SGLT1/SGLT2 inhibitor being developed as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D). The company previously submitted additional clinical data from investigator-initiated studies to support the potential resubmission of its New Drug Application (NDA) for Zynquista.

The FDA has informed Lexicon that it needs more time to review this new data. As a result, the agency now plans to provide its feedback from the previously scheduled September Type D meeting in the fourth quarter of this year, rather than by the end of September as initially expected. This update follows the FDA’s issuance of a complete response letter in December 2024, which raised concerns about an increased risk of diabetic ketoacidosis associated with Zynquista. Since then, Lexicon has engaged in discussions with the FDA about possible regulatory pathways to address these concerns. 

The company was granted a Type D meeting to review the path forward and submitted new clinical data from three ongoing, third-party funded studies: STENO1 at the Steno Diabetes Center, SUGARNSALT at the Joslin Diabetes Center, and SOPHIST at the University of Dundee. These studies are designed to provide additional evidence supporting the benefit-risk profile of Zynquista for patients with type 1 diabetes.

Lexicon stated that it remains committed to working closely with the FDA to address outstanding issues and to advance Zynquista as a potential therapy for adults with T1D who require better glycemic control. The company expects further regulatory clarity once the FDA completes its review and provides feedback later this year.