Lexicon Pharmaceuticals, Inc. announced on September 8, 2025, the submission of additional clinical data to the U.S. Food and Drug Administration (FDA). This data, from ongoing third-party funded, investigator-initiated studies, supports a potential resubmission of the New Drug Application for Zynquista (sotagliflozin) as an adjunct to insulin for glycemic control in adults with type 1 diabetes (T1D).
The submission aims to address the complete response letter issued by the FDA in December 2024, which cited concerns of increased risk of diabetic ketoacidosis. Following subsequent discussions, Lexicon was granted a Type D meeting with the FDA.
The submitted data includes findings from three ongoing studies: STENO1, SUGARNSALT, and SOPHIST, all supporting the benefit-risk profile of Zynquista in T1D. FDA feedback from the Type D meeting was expected by the end of September.
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