The European Commission has granted marketing authorization for Zynquista (sotagliflozin), developed by Sanofi and Lexicon. Zynquista is now approved in...
The FDA has accepted Sanofi's regulatory filing for oral Zynquista (sotagliflozin), to be used in addition to insulin therapy to...
The FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application for investigational Zynquista (sotagliflozin)...
Lexicon Pharmaceuticals, Inc. announced the termination of its alliance with Sanofi for the development and commercialization of Zynquista (sotagliflozin) and...
Lexicon Pharmaceuticals announced topline data from the Phase III SOTA-EMPA study for Zynquista (sotagliflozin) in type 2 diabetes. The topline...
The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted eight to eight on the question of whether the...
Sanofi announced topline results from three Phase III trials of Zynquista (sotagliflozin) in adults living with type 2 diabetes from...
Lexicon Pharmaceuticals announced that it has submitted a New Drug Application to the FDA seeking approval for the marketing and sale of Zynquista (sotagliflozin) to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Marketing...
Lexicon Pharmaceuticals announced results of a new analysis of data from the SCORED Phase III clinical trial of Zynquista (sotagliflozin) in patients with type 2 diabetes and chronic kidney disease. The SCORED clinical trial randomized 10,584 patients with type 2 diabetes and chronic kidney disease to sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, or placebo.