Is Mecasermin legal?
Written by Aaron CuhaReviewed Sep 2026
- US: FDA-approved, prescription only
- UK: Licensed, prescription only (MHRA)
- AU: TGA-registered, prescription only
- CA: Health Canada approved, prescription only
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 | Approved | Approved | Approved | Approved |
| Legal category | FDA-approved, prescription only | Licensed, prescription only (MHRA) | TGA-registered, prescription only | Health Canada approved, prescription only |
| Note | INCRELEX, BLA 021839, Ipsen, approved 30 August 2005, prescription only. It is approved for children with a severe IGF-1 shortage. Prescribing it for muscle, ageing or sport is outside its approved use, and no trials back that use. | Licensed for the same use in children. Europe first approved it in August 2007 under exceptional circumstances, a special route used because so few patients exist to study. | Registered with the TGA (Ipsen Pty Ltd) for long-term treatment of poor growth in children and teens aged two to eighteen with a severe IGF-1 shortage. | Health Canada approved it for Ipsen Biopharmaceuticals Canada in December 2020 (a Notice of Compliance), for a severe IGF-1 shortage in patients aged two to eighteen. Before that, doctors could get it only through the Special Access Programme. |
| Agency | Check FDA directly | Check MHRA directly | Check TGA directly | Check Health Canada directly |
US FDA status: FDA-approved. INCRELEX (mecasermin), BLA 021839, made by Ipsen, first approved 30 August 2005, prescription only. It is for children who are not growing because of a severe IGF-1 shortage that is not caused by low growth hormone. It is also for children missing the growth hormone gene whose immune system has started blocking growth hormone treatment. It is not approved for adults, for age-related muscle loss, for recovery or for any performance use.. Reviewed Sep 2026.
Country by country
Is Mecasermin legal in the United States?
Yes. Mecasermin is an approved medicine in the United States. Its legal category is "FDA-approved, prescription only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 1 completed human trial is cited on its profile.
The full United States answerIs Mecasermin legal in the United Kingdom?
Yes. Mecasermin is an approved medicine in the United Kingdom. Its legal category is "Licensed, prescription only (MHRA)". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 1 completed human trial is cited on its profile.
The full United Kingdom answerIs Mecasermin legal in Australia?
Yes. Mecasermin is an approved medicine in Australia. Its legal category is "TGA-registered, prescription only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 1 completed human trial is cited on its profile.
The full Australia answerIs Mecasermin legal in Canada?
Yes. Mecasermin is an approved medicine in Canada. Its legal category is "Health Canada approved, prescription only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 1 completed human trial is cited on its profile.
The full Canada answerMecasermin in sport and the military
Whether Mecasermin 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 Mecasermin 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.