Posted by Michael Wonder on 23 Sep 2025
Lexicon Pharmaceuticals announces update on submission of additional data to US FDA supporting the benefit-risk profile of Zynquista in type 1 diabetes
23 September 2025 - Data obtained from ongoing third-party funded, investigator-sponsored trials have been submitted in effort to address the December 2024 complete response letter.
Lexicon Pharmaceuticals today announced an update to the previous submission of additional clinical data to the US FDA from ongoing third-party funded, investigator-initiated studies supporting the potential resubmission of the new drug application for Zynquista (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin for glycemic control in adults with type 1 diabetes mellitus.
