Bexagliflozin: First Approval

Bexagliflozin (BRENZAVVY™) is an orally administered potent inhibitor of sodium-glucose transporter 2 (SGLT-2). It is being developed by TheracosBio for the treatment of type 2 diabetes (T2D) and essential hypertension, and in January 2023 it received its first approval in the USA for use as an adjunct to diet and exercise to improve glycaemic control in adults with T2D. Bexagliflozin is contraindicated in patients receiving dialysis and is not recommended in patients with type 1 diabetes or in those with an estimated glomerular filtration rate of < 30 mL/min/1.73 m2. Bexagliflozin is undergoing clinical development for the treatment of essential hypertension in the USA. This article summarizes the milestones in the development of bexagliflozin leading to this first approval for the treatment of T2D.