Is Rapastinel legal in the United States?

An intravenous tetrapeptide antidepressant that reduced depression scores within hours in a 116 person trial, then failed three pivotal phase 3 trials totalling about 1,500 people: placebo-adjusted differences on the MADRS of 0.3, 0.1 and 1.0 points, none significant. Allergan stopped the programme in July 2019.

Rapastinel is a four amino acid peptide that acts at the glycine site of the NMDA receptor as a functional partial agonist. It was developed by Naurex and then Allergan as a rapid acting antidepressant without ketamine's dissociative effects.

Mechanism: 5 mg/kg did. Whether rapastinel modulates NMDA receptor signalling in a human brain has not been shown directly.

Regulatory history: Not FDA approved. Phase 3 programme in major depressive disorder failed its primary endpoints (results posted on ClinicalTrials.gov 2019 to 2020) and was stopped by the sponsor in July 2019. No further development.

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 Rapastinel 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.