Bexagliflozin (Bexacat) for Feline Diabetes Mellitus

In a 2023 Journal of Veterinary Internal Medicine prospective, open-label, historically controlled field trial, bexagliflozin 15 mg PO once daily as monotherapy produced treatment success (a decrease in hyperglycemia plus improvement in clinical signs by day 56) in 68 of 81 evaluable cats (84.0%) among 84 enrolled client-owned cats newly diagnosed with diabetes mellitus. Mean serum glucose, fructosamine, and β-hydroxybutyrate concentrations all decreased. The most important adverse event was euglycemic diabetic ketoacidosis: diagnosed in 3 cats and presumed in a fourth in this trial, and a risk documented with another SGLT2 inhibitor in diabetic cats.

The Bexacat label

Bexagliflozin is marketed as Bexacat (bexagliflozin tablets). FDA approved it on December 8, 2022 as the first oral new animal drug for glycemic control in otherwise healthy cats not previously treated with insulin, and the first SGLT2 inhibitor approved in any animal species. The labeled dose equals the trial dose: one 15 mg flavored tablet PO once daily for cats 6.6 lb (3.0 kg) and greater, given at approximately the same time each day, with or without food, regardless of blood glucose.

Study design and population

• Historically controlled, prospective, open-label clinical trial in 84 client-owned cats newly diagnosed with diabetes mellitus; the stated objective was safety and effectiveness of bexagliflozin as monotherapy in previously untreated (insulin-naïve) cats.
• Cats were dosed PO with 15 mg bexagliflozin once daily for 56 days, followed by a 124-day extension to evaluate safety and durability of the treatment effect.
• Primary endpoint: the proportion of cats experiencing a decrease in hyperglycemia and improvement in clinical signs of hyperglycemia from baseline on day 56.
• Of 84 enrolled cats, 81 were evaluable on day 56; 68 (84.0%) were treatment successes.

Effectiveness findings

Beyond the 84.0% treatment-success rate, the trial reported decreases in mean serum glucose, fructosamine, and β-hydroxybutyrate concentrations, and the authors determined a fructosamine half-life of 6.8 days in diabetic cats (relevant when interpreting fructosamine after treatment initiation). Investigator assessments of neurological status, musculature, and hair coat quality improved, and owner evaluations of both cat and owner quality of life were favorable.

Safety and the euglycemic DKA risk

Commonly observed adverse events were emesis, diarrhea, anorexia, lethargy, and dehydration. Eight cats experienced serious adverse events, 3 of which led to death or euthanasia; the full text attributes those 3 deaths to weight loss with anemia, an unknown cause, and hepatic lipidosis.

The authors identified euglycemic diabetic ketoacidosis as the most important adverse event: it was diagnosed in 3 cats and presumed present in a fourth. The full text counts 4 cats with known or presumed DKA out of the 84 enrolled over the 180-day study, and dates the cases to days 2, 3, 4, and 31, three of them within the first days of treatment. All but one of the four responded to fluids, insulin, and dextrose and were transitioned to insulin; the nonresponding cat was euthanized with hepatic lipidosis, its death accompanied by hepatic and renal failure. One DKA cat was therefore among the 3 deaths. The full text instructs prompt investigation of anorexia or lethargy appearing shortly after initiation.

Because SGLT2 inhibitors lower glucose without addressing the insulin deficiency that drives ketogenesis, ketoacidosis can develop while blood glucose remains near normal. The full text warns that recognition of ketoacidosis may be delayed because the characteristic high blood glucose concentration associated with ketoacidosis is masked by inhibitor action. Normoglycemia on a blood glucose curve does not rule out ketoacidosis, and ketone (β-hydroxybutyrate) assessment should not be deferred on that basis. Per the label, DKA or euglycemic DKA is treated as an emergency: discontinue Bexacat and initiate insulin therapy.

Class context: in a 2024 randomized, positive-controlled (Caninsulin) velagliflozin field trial in diabetic cats (127 cats in the safety population, 116 in the efficacy population), DKA occurred in 4 of 61 velagliflozin-treated cats versus 0 of 66 insulin-treated cats, evidence that DKA is a class risk of SGLT2 inhibitors in feline diabetes, not a bexagliflozin-specific finding.

This page sets no monitoring-interval schedule for glucose, fructosamine, or ketones; the product label and the trial’s full text are the references for monitoring cadence.

Clinical context and patient selection

This was a single, historically controlled, open-label field study: there was no concurrent randomized control group and investigators were not blinded. It enrolled newly diagnosed, previously untreated cats only. It does not establish safety or effectiveness in insulin-dependent cats, cats previously or currently treated with insulin, or cats with a history of diabetic ketoacidosis, and the findings should not be extrapolated to those populations.

The label’s contraindications formalize that population restriction: Bexacat should not be used in cats previously treated with insulin, receiving insulin, or with insulin-dependent diabetes mellitus, and should not be initiated in cats that are not eating well, dehydrated, or lethargic at diagnosis. It carries a boxed warning covering patient selection and severe adverse reactions.

Ask Vetinuity

For follow-up questions about the labeled dose and contraindications, glycemic and ketone monitoring, or recognizing early euglycemic DKA, ask the Vetinuity clinical assistant.