Legal status · United States
Is Carbetocin (intranasal) legal in the United States?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
No. Carbetocin (intranasal) is not approved for any medical use in the United States; its classification is "Investigational, not approved". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. On the evidence, 4 human studies are cited on its profile.
Carbetocin (intranasal) in the United States at a glance
| Classification | 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. |
| FDA approval 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. |
| Human studies cited | 4 of 4 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Carbetocin (intranasal) profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.
What this means
- 01
Carbetocin (intranasal) is being studied in registered clinical trials but has not received FDA marketing approval in the United States.
- 02
Lawful human access is limited to trial participation or a formal early-access scheme where one exists; there is no pharmacy product to prescribe.
- 03
Vials sold online "for research use only" are not trial material, and that label does not make human use lawful.
What Carbetocin (intranasal) is
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.
How FDA treats this kind of product
Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.
The classification above is the The Longevity Archive reading of U.S. Food and Drug 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.
Carbetocin (intranasal) in other countries
United Kingdom
Not approvedInvestigational, not licensed
Is Carbetocin (intranasal) legal in the United Kingdom?Australia
Not approvedInvestigational, not registered
Is Carbetocin (intranasal) legal in Australia?Canada
Not approvedInvestigational, not approved
Is Carbetocin (intranasal) legal in Canada?Frequently asked questions
Is Carbetocin (intranasal) legal in the United States?
No. Carbetocin (intranasal) is not approved for any medical use in the United States; its classification is "Investigational, not approved". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. On the evidence, 4 human studies are cited on its profile. 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.
Can I buy Carbetocin (intranasal) in the United States?
No approved product exists to buy. In the United States Carbetocin (intranasal) is classified as "Investigational, not approved", so there is no licensed pharmacy product. Vendors selling it "for research use only" are not selling it for human use, and that label does not change its legal status. This site does not list or recommend vendors. 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.
Is Carbetocin (intranasal) FDA approved?
No. 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.. Current US classification: "Investigational, not approved". On the evidence, 4 human studies are cited on its profile.
Related compounds in the United States
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for Carbetocin (intranasal) live on its compound profile.
Carbetocin (intranasal) profileThis page is general information about the regulatory status of Carbetocin (intranasal) in the United States, current as of Sep 2026. It is not legal advice, and classifications change; check U.S. Food and Drug Administration directly or consult 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 and does not recommend where to buy anything.