Is Idebenone legal in the United States?

Approved in the European Union for one rare inherited eye disease that causes sudden vision loss. The approval came under special rules because the normal evidence bar was not met. The study behind it missed its main goal, and the studies in Alzheimer's disease and Friedreich ataxia found no benefit.

Idebenone is three separate products wearing one name. They should not be read as backing each other up.

How it works: Idebenone is a small, lab-made cousin of CoQ10. It can take electrons from an enzyme called NQO1 and hand them straight to a later step in the cell's energy chain, skipping a broken first step called complex I.

Approval history: 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.

Approves prescription drugs, each for a named use. It also acts against unapproved products, including peptides sold online. Compounding pharmacies, which mix drugs to order, may make some compounds with a prescription. That only applies when the FDA puts the compound in a category of bulk ingredients it allows.

The legal category above is how The Longevity Archive reads U.S. Food and Drug Administration listings for Idebenone 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 FDA directly

Whether Idebenone is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status in the United States. 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.