Bexagliflozin: First Approval

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Sheridan M. Hoy is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.

Abstract

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.

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