Is Azelaprag legal?
Written by Aaron CuhaReviewed Sep 2026
- US: Investigational; development stopped
- 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 list | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Not approved | Not approved | Not approved | Not approved |
| Legal category | Investigational; development stopped | Investigational, not licensed | Investigational, not registered | Investigational, not approved |
| Note | The mid-stage study was stopped in February 2025 because of raised liver enzymes, a sign of liver damage. No approval and no active registered trial. | No trial registered in the UK. | No trial registered in Australia. | No trial registered in Canada. |
| Agency | Check FDA directly | Check MHRA directly | Check TGA directly | Check Health Canada directly |
US FDA status: Not approved. Investigational only. The mid-stage study that combined it with tirzepatide was stopped because of raised liver enzymes, a sign of liver damage. No further azelaprag trial is registered.. Reviewed Sep 2026.
Country by country
Is Azelaprag legal in the United States?
No. Azelaprag is not approved for any medical use in the United States. Its legal category is "Investigational; development stopped". 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, no completed trial in people is cited on its profile (2 human records with no result or no dose given).
The full United States answerIs Azelaprag legal in the United Kingdom?
No. Azelaprag 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, no completed trial in people is cited on its profile (2 human records with no result or no dose given).
The full United Kingdom answerIs Azelaprag legal in Australia?
No. Azelaprag 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, no completed trial in people is cited on its profile (2 human records with no result or no dose given).
The full Australia answerIs Azelaprag legal in Canada?
No. Azelaprag 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, no completed trial in people is cited on its profile (2 human records with no result or no dose given).
The full Canada answerAzelaprag in sport and the military
Whether Azelaprag 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 Azelaprag 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.
- WADA Prohibited List
- Global DRO (check a named product)
- USADA (US athletes)
- Operation Supplement Safety (US service members)
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.