Is Efimosfermin alfa legal in Australia?

GSK's monthly copy of FGF21, a liver hormone. GSK bought it for $1.2 billion up front. The FDA gave it a Breakthrough Therapy label for fatty liver disease, and mid-stage results were published in 2026.

Efimosfermin is a lab-made copy of FGF21 that lasts long enough for one shot a month. It is the only monthly drug of this kind in development.

How it works: It turns on the FGF21 receptor for a long time. That lowers liver fat, inflammation and scarring.

Approval history: Investigational; the FDA gave it Breakthrough Therapy status, which can speed up its review

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 Efimosfermin alfa 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 Efimosfermin alfa 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 Efimosfermin alfa 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.