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

Lexicon Pharmaceuticals, Inc. has announced the submission of additional clinical data to the U.S. Food and Drug Administration (FDA) to support the potential resubmission of the New Drug Application (NDA) for Zynquista (sotagliflozin). Zynquista is an oral dual SGLT1/SGLT2 inhibitor being developed as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes.

The new data submission follows a complete response letter the company received from the FDA in December 2024. That letter raised concerns over the risk of diabetic ketoacidosis associated with the treatment. In response, Lexicon engaged in discussions with the FDA to determine possible regulatory pathways. As part of this process, the company has been granted a Type D meeting to review its resubmission plans.

Dr. Mike Exton, Ph.D., chief executive officer and director of Lexicon Pharmaceuticals, stated, “There has been an outpouring of patient support advocating for the approval of Zynquista in T1D. While we are no longer investing in clinical programs for Zynquista, we remain committed to exploring all opportunities to bring this medicine to patients, whose support for approval is unwavering.”

To address the FDA’s concerns and demonstrate the benefit-risk profile of sotagliflozin in type 1 diabetes, Lexicon has submitted results from three ongoing investigator-initiated, third-party funded studies. These include the STENO1 trial at the Steno Diabetes Center, the SUGARNSALT trial at the Joslin Diabetes Center, and the SOPHIST trial at the University of Dundee. The company expects this data to strengthen its case for resubmission and move Zynquista closer to availability for adults with type 1 diabetes who may benefit from additional options for glycemic control.