Is Rusfertide legal in Australia?

An 18 residue cyclic peptide that mimics the iron hormone hepcidin, approved by the FDA on 28 August 2026 for erythrocytosis in adults with polycythaemia vera. In the 293 person VERIFY trial, 76.9 percent on rusfertide against 32.9 percent on placebo avoided qualifying for a phlebotomy between weeks 20 and 32.

Rusfertide is a synthetic, lipidated, disulfide-bridged 18 amino acid peptide that copies the action of hepcidin, the liver hormone that controls how much iron reaches the bloodstream. In polycythaemia vera the bone marrow makes too many red cells; the standard control is repeated phlebotomy, which leaves patients iron deficient.

Mechanism: Hepcidin binds ferroportin, the only known cellular iron exporter, and causes it to be internalised and degraded. That traps iron inside gut cells and macrophages and lowers serum iron, so the marrow has less iron to build haemoglobin.

Regulatory history: FDA approved 28 August 2026 (Mimrylo, NDA 220605, new molecular entity) for the treatment of erythrocytosis in adults with polycythaemia vera. Once-weekly subcutaneous injection, 9.5 to 54 mg vials.

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 Rusfertide 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.