Lexicon Pharmaceuticals, Inc. has submitted additional clinical data to the US FDA to support the potential resubmission of the New Drug Application for Zynquista (sotagliflozin), an oral SGLT1/SGLT2 inhibitor intended as an adjunct to insulin for glycemic control in adults with type 1 diabetes (T1D). This submission follows a complete response letter from the FDA in December 2024, which raised concerns regarding the risk of diabetic ketoacidosis.
In light of discussions with the FDA concerning regulatory pathways, Lexicon has secured a Type D meeting and provided data from three ongoing studies conducted by respected institutions, including the Steno Diabetes Center and the Joslin Diabetes Center. These studies aim to reinforce the benefit-risk profile of Zynquista in the T1D patient population.
Dr. Mike Exton, CEO of Lexicon Pharmaceuticals, emphasized the strong patient advocacy for Zynquista’s approval, despite the company’s decision to halt further clinical investments in the drug. Sotagliflozin, discovered through Lexicon’s innovative gene science approach, targets SGLT1 and SGLT2 proteins, which play crucial roles in glucose regulation. With a robust clinical history involving approximately 20,000 patients across various conditions, Lexicon continues to explore avenues to make this treatment available to patients in need.
