Legal status by country
Is Carbetocin (intranasal) legal?
Written by Aaron CuhaReviewed Sep 2026
How Carbetocin (intranasal) is classified in the United States, United Kingdom, Australia and Canada, side by side. Each country has its own page with a direct answer, the regulator's approval status and what the classification means in practice.
All four countries, side by side
| Attribute | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Not approved | Not approved | Not approved | Not approved |
| Classification | Investigational, not approved | Investigational, not licensed | Investigational, not registered | Investigational, not approved |
| Note | No approved intranasal product and no FDA label. Development for Prader-Willi syndrome reached phase 3 twice and failed; the open-label extension was terminated for futility. | Not licensed in this formulation. Injectable carbetocin for postpartum haemorrhage is a separate product. | Not registered in this formulation. Injectable carbetocin for postpartum haemorrhage is a separate product. | Not authorised in this formulation. Injectable carbetocin for postpartum haemorrhage is a separate product. |
US FDA status: 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.. Reviewed Sep 2026.
Related compounds
General information current as of Sep 2026, not legal advice. Classifications change; confirm with the regulator or a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships.