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Legal status · United States

Is Glepaglutide legal in the United States?

Written by Reviewed Sep 2026

Not approvedMetabolicStudies in people cited: 6

Direct answer

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.

People given it
230
Found nothing
2

Legal category

Investigational, not approved

FDA approval and compounding status, from the Glepaglutide profile.

Reviewed Sep 2026. This is a legal category, not legal advice.

A "research use only" label on a vial does not make it legal to use on people.

Glepaglutide in the United States at a glance

Legal categoryInvestigational, not approved
FDA approval statusNot 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.
Studies in people6 of 8 sources on the profile
ReviewedSep 2026

The legal category and note come from the Glepaglutide profile. We checked them against U.S. Food and Drug Administration (FDA) listings on the reviewed date.

What this means

  • 01

    Glepaglutide is being tested in registered clinical trials (official studies in people). FDA has not approved it for sale in the United States.

  • 02

    The only legal ways for a person to get it are to join a trial, or to use an official early-access program where one exists. There is no pharmacy product to prescribe.

  • 03

    Vials sold online "for research use only" are not trial supplies. That label does not make them legal to use in people.

What Glepaglutide is

A long-lasting copy of GLP-2, a gut hormone, for people whose short bowel means they need feeding by drip. In a 106 person study, 10 mg twice a week cut weekly drip feeding by 5.13 litres, against 2.85 litres on a dummy injection. Once a week did no better than the dummy. It is not approved anywhere as of September 2026, and another large study is now recruiting.

Glepaglutide is a lab-made copy of GLP-2, the gut hormone that makes the gut lining grow and absorb more. Zealand Pharma built it to last long enough for a shot once or twice a week, from a ready-to-use injection.

How it works: The gut releases GLP-2 after meals. It makes the tiny finger-like folds of the gut lining taller and deeper, slows how fast the stomach empties, boosts blood flow to the gut, and helps it absorb fluid and food.

Approval history: 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.

How FDA treats this kind of product

Approves prescription drugs, each for a named use. It also acts against unapproved products, including peptides sold online. Compounding pharmacies, which mix drugs to order, may make some compounds with a prescription. That only applies when the FDA puts the compound in a category of bulk ingredients it allows.

The legal category above is how The Longevity Archive reads U.S. Food and Drug Administration listings for Glepaglutide on the reviewed date. It is not a legal opinion. Rules change. Bringing a compound into the country, prescribing it and owning it can each be treated differently. Check with the agency before you act on anything here.

Check FDA directly

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 in the United States. 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.

Glepaglutide in other countries

Frequently asked questions

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.

Can I buy Glepaglutide in the United States?

There is no approved product to buy. In the United States, Glepaglutide has the legal category "Investigational, not approved". So no licensed pharmacy product exists. Sellers who list it "for research use only" are not selling it for use in people, and that label does not change its legal status. 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.

Is Glepaglutide FDA approved?

No. 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.. Current US legal category: "Investigational, not approved". On the evidence, 3 completed human trials are cited on its profile.

Related compounds in the United States

Full research profile

How Glepaglutide works, the studies we cite, FDA status and the full legal summary are all on its compound profile.

Glepaglutide profile

This page is general information about the legal status of Glepaglutide in the United States, current as of Sep 2026. It is not legal advice. Legal status changes. For your own situation, check with U.S. Food and Drug Administration or ask 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.