Psiconáutica Editorial Team · 13 November 2026
At a glance
- Compass Pathways announced on 9 November 2026 that it has completed its New Drug Application (NDA) to the US Food and Drug Administration for COMP360, a synthetic psilocybin formulation, for treatment-resistant depression.
- Submitting the application is not an approval. The release also does not say the FDA has formally accepted it for review.
- Even if approved, COMP360 contains federal Schedule I substances and would need to be rescheduled by the DEA and states before it could be sold in the US.
Compass Pathways, which is headquartered in London and has a US office in New Jersey, has taken the step it had been signaling for months: completing the dossier that asks the US Food and Drug Administration (FDA) to authorize COMP360, its synthetic psilocybin, for people with treatment-resistant depression. The outcome of the review remains open.
What the release says
According to Compass, the application rests on two phase 3 trials and one phase 2b trial. Each met its primary endpoint, and together they enrolled more than 1,000 participants with what the company describes as highly chronic treatment-resistant depression. The company calls the phase 3 results “highly statistically significant.”
COMP360 holds FDA Breakthrough Therapy designation for this indication and ILAP designation in the United Kingdom. Compass says its commercial capabilities are in place and expects a launch in the first half of 2027, “subject to FDA approval.” It also mentions a late-stage trial in post-traumatic stress disorder.
What remains open
The forward-looking section of the release lists several relevant uncertainties:
- the rolling review and National Priority Voucher granted to COMP360 may not lead to a faster review or to approval;
- full phase 3 results and safety data may not be consistent with the preliminary results;
- the DEA and states may not reschedule the product in time, or at all;
- acceptance by healthcare payors is not guaranteed.
What was already known
The release itself contains no efficacy or safety figures. For reference, in July Compass reported that in its second phase 3 trial (COMP006, with 581 participants), 39% of people who received 25 mg achieved at least a 25% reduction on the MADRS scale at week 6, with benefit maintained on average through week 26. These are sponsor-reported data, with a less demanding response threshold than the usual 50%, and psilocybin was given with psychological support. We covered them in COMP360: COMP006 data through week 26 reported by Compass.
Limitations
This is a corporate press release, not a scientific publication, and we have not reviewed the dossier submitted to the FDA. The prevalence figures it gives (about 4 million people with treatment-resistant depression in the US, fewer than 5% of them on a treatment indicated for it) are company estimates based on a poster, IQVIA data and internal data. The application concerns the US only and does not change the legal status of psilocybin in Spain or elsewhere in the European Union.
What it means
According to the company, the FDA review process is continuing, although the release does not report that the agency has formally accepted the application. If the FDA authorized COMP360, the intended use would be clinical and supervised, for a specific indication, and only after the DEA and states had rescheduled the product. Until then, headlines about imminent approval call for caution. There is more context in our guide to magic mushrooms and psilocybin.
Sources
- Compass Pathways, 9 November 2026: “Compass Pathways Completes COMP360 Psilocybin New Drug Application to U.S. FDA for Treatment-Resistant Depression”.
Image
Illustrative image of Buildings 1 and 21 on the FDA White Oak campus (Silver Spring, Maryland) in 2009. Credit: U.S. Food and Drug Administration, published on its Flickr account and available on Wikimedia Commons. A US federal government work, in the public domain in the United States (Public Domain Mark).
Educational content written from a harm-reduction perspective and with respect for individual freedom. It does not replace information from a healthcare professional and does not aim to encourage or condemn any drug use.
