Bexatil

Opinion

EMA has issued an opinion on this medicine

Bexagliflozin

Overview

On 16 July 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the veterinary medicinal product Bexatil, tablet, intended for cats. The applicant for this veterinary medicinal product is Elanco GmbH. 

Bexatil is a blood glucose lowering medicinal product containing Bexagliflozin (ATCvet code QA10BK08) as the active substance, an inhibitor of sodium-glucose co-transporter 2 (SGLT2). Inhibition of SGLT-2 leads to glucose elimination in the urine resulting in a decrease in elevated blood glucose levels in diabetic cats.

The benefits of Bexatil are the reduction of hyperglycaemia in cats with diabetes mellitus not previously treated with insulin.

The most common side effects are vomiting, diarrhoea or loose stool, urinary tract infection, decreased appetite, anorexia, dehydration, lethargy, weight loss, high pancreatic-specific lipase and elevated blood urea nitrogen (BUN). Diabetic ketoacidosis must be screened for prior to treatment start and monitored during treatment.

Detailed conditions for the use of this product are described in the summary of product characteristics (SPC) which will be published in the Union Product Database (UPD) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for Bexatil and therefore recommends the granting of the marketing authorisation.

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Note: Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.

CVMP summary of positive opinion for Bexatil

Adopted Reference Number: EMA/CVMP/154941/2026

Product details

• Name of medicine:
  Bexatil
• Active substance:
  bexagliflozin
• International non-proprietary name (INN) or common name:
  Bexagliflozin
• Species:
  Cats
• EMA product number:
  EMEA/V/C/006300
• Marketing authorisation applicant:
  Elanco GmbH
• Opinion adopted:
  16/07/2026
• Opinion status:
  Positive