Drug discovery and development company Lexicon Pharmaceuticals has obtained FDA approval for INPEFA (sotagliflozin), an oral tablet designed to lower the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The approval applies to a wide range of heart failure patients, irrespective of ejection fraction or diabetes status. Commercial availability in the US market is anticipated by June 2023.

INPEFA is an inhibitor of two proteins—sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1)—and has been studied in multiple patient populations. The product demonstrated significant risk reduction for hospitalizations for heart failure, urgent visits for heart failure, and cardiovascular death in patients recently hospitalized for worsening heart failure. 

Lexicon Pharmaceuticals is a biopharmaceutical company focused on discovering and developing pharmaceutical products for the treatment of various chronic diseases. Its research spans immunology, metabolism, cardiology, and ophthalmology. With six drug candidates in its pipeline, including LX1031 for gastrointestinal disorders and LX4211 for type 2 diabetes, the company also has a preclinical candidate, LX7101, for glaucoma treatment. Lexicon Pharmaceuticals has established collaborations with leading pharmaceutical companies like Bristol-Myers Squibb, Genentech, N.V. Organon, and Takeda Pharmaceutical.