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Legal status · Australia

Is Glepaglutide legal in Australia?

Written by Reviewed Sep 2026

Not approvedMetabolicStudies in people cited: 6

Direct answer

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.

People given it
230
Found nothing
2

Legal category

Investigational, not registered

TGA registration and the Poisons Standard schedule, 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 Australia at a glance

Legal categoryInvestigational, not registered
TGA approval statusNot approved by TGA; investigational (still being tested in trials)
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 Therapeutic Goods Administration (TGA) listings on the reviewed date.

What this means

  • 01

    Glepaglutide is being tested in registered clinical trials (official studies in people). TGA has not approved it for sale in Australia.

  • 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 TGA treats this kind of product

Registers or lists medicines and health products on the ARTG, its official register. It also sorts substances into schedules in the Poisons Standard. Many peptides are Schedule 4 (prescription only). So having them without a prescription, or importing them for yourself, is restricted. That is true even when no product is registered.

The legal category above is how The Longevity Archive reads Therapeutic Goods 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 TGA 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 Australia. 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 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.

Can I buy Glepaglutide in Australia?

There is no approved product to buy. In Australia, Glepaglutide has the legal category "Investigational, not registered". 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 TGA approved?

No. In Australia, Glepaglutide has the legal category "Investigational, not registered". That is not a TGA approval to sell it. For comparison, its US FDA status is: 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.. On the evidence, 3 completed human trials are cited on its profile.

Related compounds in Australia

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 Australia, current as of Sep 2026. It is not legal advice. Legal status changes. For your own situation, check with Therapeutic Goods 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.