Is Carbetocin (intranasal) legal in Australia?

A failed programme, reported as one. Both phase 3 trials in Prader-Willi syndrome missed their primary endpoint, the confirmatory trial returned a treatment difference of 0.3 points on hyperphagia with P = 0.79 and a point estimate favouring placebo, and the open-label extension was terminated by the sponsor for futility.

This entry exists because intranasal carbetocin is frequently cited as evidence that oxytocin-pathway drugs work on behaviour. The trials it is cited from failed.

Mechanism: The oxytocin receptor agonism is established pharmacology. Carbetocin binds the oxytocin receptor with greater selectivity and a longer duration than oxytocin, which is the whole point of the molecule.

Regulatory history: Not approved. An openFDA drug-label query for the generic name carbetocin returns no matches, consistent with no approved United States product. After the confirmatory phase 3 failure and the termination of the extension study, there is no active path to approval for the intranasal formulation.

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 Carbetocin (intranasal) 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.