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Is Glepaglutide legal?

Written by Reviewed Sep 2026

MetabolicModerate. At least one finished study in people, and at least 100 people who took it. 3 completed trials, 230 people given it.
  • US: Investigational, not approved
  • UK: Investigational, not licensed
  • AU: Investigational, not registered
  • CA: Investigational, not approved

The US comes first because most people ask about it. Each country has its own page. It names the agency, the law or rule, and what the legal category means in real life.

All four countries, side by side

What we listUnited States · FDAUnited Kingdom · MHRAAustralia · TGACanada · Health Canada
StatusNot approvedNot approvedNot approvedNot approved
Legal categoryInvestigational, not approvedInvestigational, not licensedInvestigational, not registeredInvestigational, not approved
NoteNone recordedNone recordedNone recordedNone recorded
AgencyCheck FDA directlyCheck MHRA directlyCheck TGA directlyCheck Health Canada directly

US FDA status: Not FDA approved. No application in the FDA drug database (Drugs@FDA) and no European (EMA) medicine page as of 11 September 2026. The final-stage study EASE SBS-1 is finished. A second final-stage study to confirm the results (NCT07197944) has been signing people up since February 2026.. Reviewed Sep 2026.

Country by country

Is Glepaglutide legal in the United States?

No. Glepaglutide is not approved for any medical use in the United States. Its legal category is "Investigational, not approved". The only legal way to get it is to join a registered clinical trial (an official study in people). A "research use only" label on vials sold online does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.

The full United States answer

Is Glepaglutide legal in the United Kingdom?

No. Glepaglutide is not approved for any medical use in the United Kingdom. Its legal category is "Investigational, not licensed". The only legal way to get it is to join a registered clinical trial (an official study in people). A "research use only" label on vials sold online does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.

The full United Kingdom answer

Is Glepaglutide legal in Australia?

No. Glepaglutide is not approved for any medical use in Australia. Its legal category is "Investigational, not registered". The only legal way to get it is to join a registered clinical trial (an official study in people). A "research use only" label on vials sold online does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.

The full Australia answer

Is Glepaglutide legal in Canada?

No. Glepaglutide is not approved for any medical use in Canada. Its legal category is "Investigational, not approved". The only legal way to get it is to join a registered clinical trial (an official study in people). A "research use only" label on vials sold online does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.

The full Canada answer

Glepaglutide in sport and the military

Whether Glepaglutide is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status. Before you compete or get tested, look up Glepaglutide by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.

The rules you compete or serve under decide this, not this page.

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General information, current as of Sep 2026. Not legal advice. Legal status changes. For your own situation, check with the agency or a lawyer. Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.