Is Carbetocin (intranasal) legal in the United States?

A failed drug program, and this page says so. Both large final-stage studies in Prader-Willi syndrome missed their main goal. In the check study, hunger scores differed by just 0.3 points between the nasal spray and a dummy spray, with the dummy slightly ahead. The company then stopped its own follow-on study because carrying on was not likely to help.

This page exists because carbetocin nasal spray is often held up as proof that oxytocin-type drugs change behaviour. The studies it is cited from failed.

How it works: Carbetocin does turn on the oxytocin receptor. It is more selective and lasts longer than oxytocin, which is the whole point of the molecule.

Approval history: Not approved. A search of the FDA's public drug-label database for carbetocin finds nothing, which fits with there being no approved US product. The final-stage follow-up study failed and the extension study was stopped. So the nasal spray version has no active path to approval.

Approves prescription drugs, each for a named use. It also acts against unapproved products, including peptides sold online. Compounding pharmacies, which mix drugs to order, may make some compounds with a prescription. That only applies when the FDA puts the compound in a category of bulk ingredients it allows.

The legal category above is how The Longevity Archive reads U.S. Food and Drug Administration listings for Carbetocin (intranasal) on the reviewed date. It is not a legal opinion. Rules change. Bringing a compound into the country, prescribing it and owning it can each be treated differently. Check with the agency before you act on anything here.

Check FDA directly

Whether Carbetocin (intranasal) is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status in the United States. Before you compete or get tested, look up Carbetocin (intranasal) by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.

• WADA Prohibited List
• Global DRO (check a named product)
• USADA (US athletes)
• Operation Supplement Safety (US service members)

The rules you compete or serve under decide this, not this page.