Legal status by country
Is Idebenone legal?
Written by Aaron CuhaReviewed Sep 2026
How Idebenone is classified in the United States, United Kingdom, Australia and Canada, side by side. Each country has its own page with a direct answer, the regulator's approval status and what the classification means in practice.
All four countries, side by side
| Attribute | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Not approved | Not approved | Not approved | Not approved |
| Classification | Not approved; sold in cosmetics and supplements | Prescription medicine in the European Union (Raxone) | Not registered | Not approved |
| Note | No FDA approval for any indication. Idebenone appears in topical antioxidant skincare and in oral nootropic products sold without approval for a medical use. | Raxone holds an EU marketing authorisation granted in September 2015, under exceptional circumstances, for Leber hereditary optic neuropathy. Current Great Britain licensing status was not verified for this entry. | No TGA registration located; idebenone also appears in cosmetic preparations. | No Health Canada authorisation located; sold in cosmetic antioxidant products. |
US FDA status: Not FDA approved for any indication. Authorised in the European Union as Raxone for Leber hereditary optic neuropathy since September 2015, under exceptional circumstances. Separately sold in topical skincare and in oral nootropic supplements, neither of which is an approved use.. Reviewed Sep 2026.
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General information current as of Sep 2026, not legal advice. Classifications change; confirm with the regulator or a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships.