Is Carbetocin (intranasal) legal in the United Kingdom?

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.

Licenses medicines for the UK market. A compound without a marketing authorisation is an unlicensed medicine, which can only lawfully be supplied for human use through a prescriber under the specials scheme, not sold as a research product.

The classification above is the The Longevity Archive reading of Medicines and Healthcare products Regulatory Agency 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.