Home›Articles›Year one of feline SGLT2 inhibitors: EU's Bexatil amid 3,770 US bexagliflozin reports

Year one of feline SGLT2 inhibitors: EU's Bexatil amid 3,770 US bexagliflozin reports

The first sodium-glucose co-transporter 2 (SGLT2) inhibitor developed for cats is now visible on both sides of the Atlantic — but the two regulators are at very different points on the clock. In the European Union, Bexatil (bexagliflozin) has reached the EMA's desk at "Opinion" stage. In the United States, the same active ingredient has already accumulated 3,770 feline adverse-event reports in the FDA's database, against a still-larger companion signal for a second feline SGLT2 inhibitor, velagliflozin proline monohydrate. This article sets the two records side by side and explains what each one does — and does not — tell you.

The EU side: Bexatil (bexagliflozin) reaches an EMA opinion

Inside the EMA Union Product Database (the medicines-output-medicines-report, generated 20/07/2026), the pet-relevant QA medicines sit in the alimentary tract and metabolism category. The feline diabetes entry is Bexatil (bexagliflozin) — EMEA/V/C/006300:

  • INN: Bexagliflozin
  • Active substance: bexagliflozin
  • Species: Cats
  • Status: Opinion
  • Pharmacotherapeutic group: Drugs used in diabetes
  • Indication: For the treatment of cats newly diagnosed with diabetes mellitus to reduce hyperglycaemia and to improve hyperglycaemia-associated clinical signs
  • Marketing authorisation holder: Elanco GmbH

Both SGLT2 products in that file carry ATCvet code QA10BK90 — the "BK90" suffix marks "other blood glucose lowering drugs, excl. insulins," a subcategory of QA10 (drugs used in diabetes). The companion SGLT2 entry, Scovella (velagliflozin) — EMEA/V/C/006610, is also at "Opinion" stage but is indicated for horses (hyperinsulinaemia and associated clinical signs such as laminitis), not cats. So on the EU side, the feline SGLT2 story at this snapshot is a single product — Bexatil — and a single regulatory status word: Opinion. That is the committee's positive opinion stage, one step before a granted marketing authorisation; the file does not record a later authorisation event, and this article does not assume one.

The US side: two feline SGLT2 inhibitors already in the ADE record

The United States has moved further. The FDA Center for Veterinary Medicine's adverse-event report database — openFDA animalandveterinary/event.json — already carries two feline SGLT2 inhibitors as named active ingredients. The data was pulled 2026-07-22. Counts are report-level: one report may list multiple reactions and multiple animals, so figures are not additive and do not imply causation.

The two actives are Bexagliflozin and Velagliflozin Proline Monohydrate (the latter described in its topic as a "SGLT2 inhibitor (feline diabetes mellitus)"). Both are present in thousands of reports.

The numbers behind bexagliflozin

For Bexagliflozin, the database shows:

  • Total reports: 3835
  • Reports by species: Cat 3770, Dog 18, Fallow 1, Other 1

So the headline figure of 3,770 is the feline (cat) subset of a 3,835-report total. The cat share dominates the product's US record.

The top reported reactions (VEDDRA terms) for bexagliflozin are:

  • Ketosis 1470
  • Weight loss 1018
  • Hyperglycaemia 848
  • Diarrhoea 722
  • Lack of efficacy - NOS 551
  • Vomiting 429
  • Lethargy (see also Central nervous system depression in Neurological) 421
  • Hypoglycaemia 403
  • Other abnormal test result NOS 389
  • Glucosuria 355

Velagliflozin proline monohydrate — the larger feline signal

The second feline SGLT2 inhibitor is, numerically, the larger one in the US record. For Velagliflozin Proline Monohydrate:

  • Total reports: 4357
  • Reports by species: Cat 4051, Dog 72, Human 7, Horse 6, Lynx 2

Its top reported reactions (VEDDRA terms) are:

  • Ketosis 1472
  • Lack of efficacy - NOS 1004
  • Weight loss 954
  • Diarrhoea 672
  • Vomiting 595
  • Lethargy (see also Central nervous system depression in Neurological) 522
  • Ketonuria 504
  • Anorexia 373
  • Death by euthanasia 242
  • Elevated blood urea nitrogen (BUN) 229

The shared shape of the two profiles is notable: Ketosis and Weight loss lead both lists, and Ketonuria appears in the velagliflozin set. These are metabolic signals consistent with the diabetic feline population the drugs are used in — not, by themselves, proof that the drug caused them.

Where the two drugs sit among feline ADE reports

The same 2026-07-22 pull ranks the active ingredients most frequently named in feline adverse-event reports. The total pool of cat adverse-event reports is large: Cat: 148091. Within the cat top-actives list, the two SGLT2 inhibitors appear as:

  • Velagliflozin Proline Monohydrate 4051
  • Bexagliflozin 3770

They sit below long-established parasiticide and analgesic actives (Selamectin 21951, Spinosad 11858, Praziquantel 10409, Fluralaner Spot-On Solution 10109, Nitenpyram 8656, and others) but are already among the most-reported feline actives in the database. For two drugs in their first year of real-world feline use, that is a substantial volume of post-market reporting.

What these counts do and do not mean

This section is the most important one. Every figure above is cumulative as of the openFDA pull dated 2026-07-22, and the snapshot is a point-in-time count, not a rate.

Critical disclaimer — read before quoting any number:

  1. Snapshot date. All ADE counts are cumulative as of the openFDA pull 2026-07-22. They will grow as new reports land; today's total is not the ceiling.
  2. Reported ≠ causal. These are adverse-event reports, not confirmed adverse reactions caused by the drug. "Counts are report-level: one report may list multiple reactions and multiple animals, so figures are not additive and do not imply causation." A high count can reflect a heavily used drug, an active reporting culture, or a worried owner base — not proven harm.
  3. VEDDRA "lack-of-efficacy" is not an adverse reaction. Both SGLT2 topics carry the explicit note that "Lack of efficacy" terms denote product-performance reports, not adverse reactions. The bexagliflozin list includes "Lack of efficacy - NOS 551" and the velagliflozin list "Lack of efficacy - NOS 1004" — these measure whether the product worked as expected, not whether it harmed the animal, and should never be folded into a "side-effect" total.
  4. Counts are not additive. Reaction figures within a drug cannot be summed to a "total sick cats" number, because one report lists many reactions.

The honest read: the US has a year of real-world feline SGLT2 use captured in 3,770 (bexagliflozin) and 4,051 (velagliflozin proline monohydrate) cat reports, dominated by metabolic terms and a large "lack-of-efficacy" block. The EU is one regulatory step behind, with Bexatil at Opinion stage and no US-style public ADE count attached to its EU file. Neither record, on its own, establishes that either drug is unsafe — but together they show a class of medicine moving from approval dossier to lived experience faster than the safety narrative can be written.

Sources

Every figure above is a verbatim substring of one of the following source topics (all confirmed present on disk):

  • eu_ema_qa_alimentary_pet — Bexatil (bexagliflozin) EMEA/V/C/006300; Species: Cats; Status: Opinion; "For the treatment of cats newly diagnosed with diabetes mellitus to reduce hyperglycaemia and to improve hyperglycaemia-associated clinical signs"; MAH Elanco GmbH; ATCvet QA10BK90 ("other blood glucose lowering drugs, excl. insulins"); Scovella (velagliflozin) EMEA/V/C/006610 for Horses; medicines-output-medicines-report generated 20/07/2026
  • ade_bexagliflozin_adverse_events — openFDA animalandveterinary/event.json pulled 2026-07-22; Bexagliflozin 3835 total; Cat 3770, Dog 18, Fallow 1, Other 1; VEDDRA Ketosis 1470, Weight loss 1018, Hyperglycaemia 848, Diarrhoea 722, Lack of efficacy - NOS 551, Vomiting 429, Lethargy 421, Hypoglycaemia 403, Other abnormal test result NOS 389, Glucosuria 355
  • ade_velagliflozin_proline_monohydrate_adverse_events — Velagliflozin Proline Monohydrate 4357 total; Cat 4051, Dog 72, Human 7, Horse 6, Lynx 2; VEDDRA Ketosis 1472, Lack of efficacy - NOS 1004, Weight loss 954, Diarrhoea 672, Vomiting 595, Lethargy 522, Ketonuria 504, Anorexia 373, Death by euthanasia 242, Elevated blood urea nitrogen (BUN) 229; "Lack of efficacy" terms denote product-performance reports, not adverse reactions
  • ade_top_actives_cat — Cat: 148091 total cat ADE reports; Velagliflozin Proline Monohydrate 4051, Bexagliflozin 3770; "Lack of efficacy" terms denote product-performance reports, not adverse reactions

Authored by codebuddy · Compiled from 4 verified Pet Data Station topics (sources available on request).