Is Idebenone legal?
Written by Aaron CuhaReviewed Sep 2026
- US: Not approved; sold in cosmetics and supplements
- UK: Prescription medicine in the European Union (Raxone)
- AU: Not registered
- CA: 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 | Not approved; sold in cosmetics and supplements | Prescription medicine in the European Union (Raxone) | Not registered | Not approved |
| Note | No FDA approval for any use. Idebenone is in antioxidant skin creams and in brain-boosting pills, sold without approval for any medical use. | Raxone was approved for sale in the EU in September 2015, under exceptional circumstances, for Leber hereditary optic neuropathy. We did not check whether it is currently licensed in Great Britain. | We found no TGA registration. Idebenone also appears in cosmetics. | We found no Health Canada approval. It is sold in antioxidant cosmetics. |
| Agency | Check FDA directly | Check MHRA directly | Check TGA directly | Check Health Canada directly |
US FDA status: Not FDA approved for any use. Approved in the European Union as Raxone since September 2015, under exceptional circumstances, a special route used when a disease is too rare to collect full data. It treats Leber hereditary optic neuropathy, an inherited disease that causes sudden vision loss. It is also sold in skin care and in brain-boosting supplements. Neither of those is an approved use.. Reviewed Sep 2026.
Country by country
Is Idebenone legal in the United States?
No. Idebenone is not an approved medicine in the United States. Its legal category is "Not approved; sold in cosmetics and supplements". Nothing that contains it is allowed for any use in people. Vials labeled "for research use only" get no exception: that label does not make them legal to use in people. On the evidence, 5 completed human trials are cited on its profile.
The full United States answerIs Idebenone legal in the United Kingdom?
No. Idebenone is not an approved medicine in the United Kingdom. Its legal category is "Prescription medicine in the European Union (Raxone)". Nothing that contains it is allowed for any use in people. Vials labeled "for research use only" get no exception: that label does not make them legal to use in people. On the evidence, 5 completed human trials are cited on its profile.
The full United Kingdom answerIs Idebenone legal in Australia?
No. Idebenone is not an approved medicine in Australia. Its legal category is "Not registered". Nothing that contains it is allowed for any use in people. Vials labeled "for research use only" get no exception: that label does not make them legal to use in people. On the evidence, 5 completed human trials are cited on its profile.
The full Australia answerIs Idebenone legal in Canada?
No. Idebenone is not an approved medicine in Canada. Its legal category is "Not approved". Nothing that contains it is allowed for any use in people. Vials labeled "for research use only" get no exception: that label does not make them legal to use in people. On the evidence, 5 completed human trials are cited on its profile.
The full Canada answerIdebenone in sport and the military
Whether Idebenone 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 Idebenone 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.