Lexicon Pharmaceuticals Announces Submission of Additional Data to U.S. FDA Supporting the Benefit-Risk Profile of Zynquista® in Type 1 Diabetes

Core Insights - Lexicon Pharmaceuticals has submitted additional clinical data to the FDA to support the resubmission of the New Drug Application for Zynquista (sotagliflozin) as an adjunct to insulin for glycemic control in adults with type 1 diabetes [1][2] - The submission follows a complete response letter from the FDA in December 2024, which raised concerns about the risk of diabetic ketoacidosis [2] - The company has received feedback from the FDA and is seeking alignment on a reasonable path forward for the Zynquista NDA resubmission [1][2] Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to study nearly 5,000 genes and identify over 100 protein targets with therapeutic potential [5] - The company has a pipeline of drug candidates in various stages of development, targeting conditions such as neuropathic pain, hypertrophic cardiomyopathy, obesity, and metabolism [5] Clinical Studies - Data submitted to the FDA includes results from three ongoing studies of sotagliflozin conducted by the Steno Diabetes Center (STENO1), Joslin Diabetes Center (SUGARNSALT), and the University of Dundee (SOPHIST) [2] - Sotagliflozin is an oral inhibitor of SGLT1 and SGLT2, proteins involved in glucose regulation, and has been studied in approximately 20,000 patients across multiple conditions [3]