Lexicon Submits Additional Clinical Data to FDA for Sotagliflozin in Type 1 Diabetes

Lexicon Pharmaceuticals has submitted additional clinical data to the U.S. Food and Drug Administration (FDA) to support the benefit-risk profile of sotagliflozin (Zynquista) for glycemic control in adults with type 1 diabetes (T1D). This submission follows a December 2024 complete response letter from the FDA that raised concerns about an increased risk of diabetic ketoacidosis linked to the drug. The new data comes from three ongoing, third-party funded studies conducted by the Steno Diabetes Center, Joslin Diabetes Center, and University of Dundee, which aim to address these safety concerns and demonstrate potential benefits such as cardiovascular and kidney outcomes. While Lexicon is no longer investing in clinical programs for Zynquista, the company remains committed to pursuing regulatory approval, with an FDA Type D meeting scheduled and feedback expected by the end of September 2025. Patient advocacy for Zynquista's approval remains strong, reflecting demand for new treatment options in T1D management. Despite financial challenges, Lexicon continues to focus on advancing its drug pipeline and regulatory efforts.