Is Idebenone legal in Australia?

Authorised in the European Union for one rare mitochondrial optic neuropathy, granted under exceptional circumstances because the normal evidence standard was not met. The randomised trial that supported it missed its primary endpoint, and the trials in Alzheimer's disease and Friedreich ataxia were negative.

Idebenone is three separate products wearing one name, and they should not be read as supporting each other. The medicine.

Mechanism: A short-chain benzoquinone that can accept electrons from cytosolic NAD(P)H quinone dehydrogenase 1 and deliver them to complex III, bypassing a defective complex I. That is a coherent rationale for a disease caused by complex I mutations, which is what Leber hereditary optic neuropathy is, and it is why the drug found its indication there rather than in general antioxidant use.

Regulatory history: 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.

Registers or lists therapeutic goods on the ARTG and schedules substances in the Poisons Standard. Many peptides are Schedule 4 (prescription only), so possession without a prescription and personal importation are restricted even when no product is registered.

The classification above is the The Longevity Archive reading of Therapeutic Goods Administration listings for Idebenone at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.