ZYNQUISTA (sotagliflozin) — Regulatory decision
in 2026
Viatris anticipates regulatory decisions in Australia and Canada and regulatory submissions in other markets in 2026.Source filing
LXRX biotech catalysts & pipeline
LEXICON PHARMACEUTICALS INC · Data as of 2026-09-08
Upcoming catalysts
ZYNQUISTA (sotagliflozin) — NDA/BLA submission
Q4 2026
STENO1, a third-party funded, investigator-initiated study of sotagliflozin being conducted by the STENO Diabetes Center (Denmark) is approaching the patient exposure and safety data requirements previously identified by the U.S. Food and Drug Administration (FDA) as being adequate to support a resubmission of the company's New Drug Application (NDA), which Lexicon anticipates will occur in the fourth quarter of 2026 based on current estimated timing of data collection.Source filing
LX9851 — Full data
Q1 2027
The Phase 1 program is expected to be completed in the first quarter of 2027.Source filing
ZYNQUISTA (sotagliflozin) — Topline data
Q1 2027
Lexicon continues to expect topline results in the first quarter of 2027.Source filing