Is Elamipretide legal in Australia?

Approved in 2025 for one rare genetic disease, Barth syndrome, on a result its own main study missed. In a large final-stage study in an inherited muscle disease, it clearly did not help.

Elamipretide goes to the inner wall of mitochondria, the power plants in your cells. It sticks to a fat there called cardiolipin.

How it works: It sticks to cardiolipin, a fat in the inner wall of mitochondria. That helps hold the folds of the wall in shape, so the cell's power plant makes energy (ATP) better.

Approval history: FDA-approved September 19, 2025 as Forzinity for Barth syndrome, a rare inherited disease. It was an early, conditional (accelerated) approval. Other uses are investigational

Registers or lists medicines and health products on the ARTG, its official register. It also sorts substances into schedules in the Poisons Standard. Many peptides are Schedule 4 (prescription only). So having them without a prescription, or importing them for yourself, is restricted. That is true even when no product is registered.

The legal category above is how The Longevity Archive reads Therapeutic Goods Administration listings for Elamipretide 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 TGA directly

Whether Elamipretide is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status in Australia. Before you compete or get tested, look up Elamipretide 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.