Legal status · Canada
Is Rapastinel legal in Canada?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
No. Rapastinel is not approved for any medical use in Canada; 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, 7 human studies are cited on its profile.
Rapastinel in Canada at a glance
| Classification | Investigational, not approved |
|---|---|
| Health Canada approval status | Not approved by Health Canada; investigational |
| Human studies cited | 7 of 7 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Rapastinel profile, checked against Health Canada, Health Products and Food Branch (Health Canada) listings at the reviewed date.
What this means
- 01
Rapastinel is being studied in registered clinical trials but has not received Health Canada marketing approval in Canada.
- 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 Rapastinel is
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.
How Health Canada treats this kind of product
Authorises drugs for sale through a Notice of Compliance and Drug Identification Number. A compound that is not authorised for sale cannot lawfully be sold for human use, and personal importation of prescription drugs is limited.
The classification above is the The Longevity Archive reading of Health Canada, Health Products and Food Branch 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.
Rapastinel in other countries
Frequently asked questions
Is Rapastinel legal in Canada?
No. Rapastinel is not approved for any medical use in Canada; 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, 7 human studies are cited on its profile.
Can I buy Rapastinel in Canada?
No approved product exists to buy. In Canada Rapastinel 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.
Is Rapastinel Health Canada approved?
No. In Canada Rapastinel is classified as "Investigational, not approved", which is not a Health Canada marketing approval. For comparison, the US FDA status is: 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.. On the evidence, 7 human studies are cited on its profile.
Related compounds in Canada
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for Rapastinel live on its compound profile.
Rapastinel profileThis page is general information about the regulatory status of Rapastinel in Canada, current as of Sep 2026. It is not legal advice, and classifications change; check Health Canada, Health Products and Food Branch 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.