COMP360 and the FDA: what a U.S. psilocybin approval would mean for Canada

COMP360 is a psilocybin formulation developed by Compass Pathways, studied in treatment-resistant depression. People ask whether the FDA has approved it, and what that would mean in Canada. This page answers from primary sources only: the company’s own filings and press releases, the FDA, the ClinicalTrials.gov registry and Health Canada. Every status below carries a date. Where we could not confirm something, we say “not established” instead of guessing.

Has the FDA approved COMP360?

As of 4 October 2026, we found no FDA approval of COMP360 in any source we opened, and no announcement that the application has been completed. The most recent company statements we could open are dated 5 August 2026. In its quarterly press release, Compass said a rolling submission and initial review were underway, with completion expected in the fourth quarter (Compass, 5 Aug 2026). The quarterly report filed the same day says the FDA granted the company’s request for a rolling review of its New Drug Application (NDA), and that this review “is ongoing” (Form 10-Q, 5 Aug 2026).

We checked the company’s SEC filing list for anything newer. The latest entry in the list we opened, which showed filings through 10 August 2026, is an insider-share notice on that date, not a regulatory announcement (SEC EDGAR listing). That is a limit of what we opened, not proof that nothing happened since: check the company’s investor page and EDGAR directly.

The word “rolling” matters: the company’s filings describe a submission that is still in progress, not a finished one. The FDA describes the NDA as the formal route by which a sponsor asks the agency to approve a new drug for sale, and the review asks whether the drug is safe and effective for its proposed use and whether benefits outweigh risks (FDA, NDA overview). Until the final section is in and the FDA decides, COMP360 is an investigational drug.

A dated timeline from primary sources

Those launch and completion dates are the company’s expectations. They are not FDA decisions, and the company’s own press release says its forward-looking statements are uncertain (Compass, 24 Apr 2026). We have not assumed any approval or submission date.

What do the COMP005 and COMP006 registry entries show?

The two phase 3 trials are public in the U.S. National Library of Medicine’s ClinicalTrials.gov registry. These are the sponsor’s registry entries as we read them on 4 October 2026.

Sources: COMP005 record; COMP006 record. We read the registry through its public data interface. The listing of a Canadian site shows where the trial was set up, not that Health Canada has authorized COMP360 for sale.

What the companies report about results: the 10-Q says COMP005 met its primary endpoint at six weeks with a difference of 3.6 points on the MADRS depression rating scale (p<0.001), and COMP006 met its primary endpoint with a difference of 3.8 points (p<0.001) (Form 10-Q). These are the sponsor’s reports. We did not verify a peer-reviewed publication of the phase 3 results for this page, so independent appraisal is not established here. For what the trial evidence in depression looks like more broadly, and its limits, see our guide to psilocybin depression trials.

What does the FDA’s national priority voucher change?

It is about speed, not about the standard. The FDA’s FAQ for the Commissioner’s National Priority Voucher pilot describes a target review period of approximately one to two months once the pre-submission and filing assessment phases are complete, and says approval decisions stay with the FDA’s usual review centres (FDA CNPV FAQ). Compass’s own release says the voucher does not change the safety and efficacy standards for approval (Compass, 24 Apr 2026).

We make no prediction about when, or whether, a decision will come. A shorter target review does not tell you the outcome, and the voucher is not an approval.

FDA approval, Health Canada authorization and CDSA scheduling: what is the difference?

These are three different decisions made by three different bodies under three different legal frameworks. News headlines often blur them.

On the Canadian side, Health Canada says manufacturers get authorization to sell a new innovator drug by filing a New Drug Submission under the Food and Drug Regulations, and receive a Notice of Compliance once they meet its requirements for safety, efficacy and quality (Health Canada, Notice of Compliance; page last modified 28 February 2018).

Separately, the Controlled Drugs and Substances Act (CDSA) lists psilocin (item 11) and psilocybin (item 12) in its Schedule III, in the consolidation current to 21 September 2026 (Justice Laws, CDSA). The Act lets the Governor in Council amend Schedules I to IV by order when it considers that necessary in the public interest (section 60), and lets the Minister of Health exempt a person, class or substance from the Act for a medical or scientific purpose or otherwise in the public interest (section 56(1)). For how the substance came to be in that schedule, see how magic mushrooms became illegal in Canada.

A parallel exists in the U.S., and Compass describes it: it says COMP360 contains Schedule I controlled substances and “must be rescheduled” by the DEA before it can be commercialized in the U.S. (Form 10-Q). That is a U.S. step on top of FDA approval. It is the company’s description; we did not open the DEA’s own pages.

What would a U.S. approval change in Canada?

Nothing we read says that an FDA approval would, by itself, switch anything on in Canada. What we can establish is narrower, and each point below is tied to a page we opened.

• It would not be a Canadian authorization. Health Canada describes authorization as the result of a manufacturer’s own submission to Health Canada (Health Canada, Notice of Compliance). We found no mention of Canada or Health Canada in Compass’s 5 August 2026 quarterly report or press release, so the company’s Canadian plans are not established.
• It would not change the CDSA schedule on its own. The schedule entries are set in Canadian law, and the power to change them sits with the Governor in Council by order (Justice Laws, CDSA). We found no provision that links an FDA decision to a Canadian schedule change.
• It would not change the legal status of mushrooms. Health Canada’s magic mushrooms page, last modified 20 October 2026, says production, sale and possession of magic mushrooms are illegal in Canada (Health Canada). A pharmaceutical product is a different thing from a mushroom, and nothing in the sources we read links an approval of one to the legal status of the other.
• It could become one input to Health Canada’s thinking, but how is not established. Health Canada published draft guidance on 15 July 2026 on a Ministerial Reliance Order under which it could treat some examination requirements as met based on a foreign regulator’s decision. The overview says it still decides whether to authorize a drug and sets conditions such as identical formulation (Health Canada draft guidance). The page we read does not say which regulators count, and says nothing about controlled substances. Whether it could apply to a psilocybin product is not established.

What about the Special Access Program?

Canada already has a route that does not depend on any approval. Health Canada’s Special Access Program lets a health practitioner request a drug that is unavailable for sale in Canada, for serious or life-threatening conditions where conventional treatments have failed, are unsuitable or are unavailable (Health Canada, Special Access Program; page modified 8 April 2026). Health Canada’s magic mushrooms page names three legal routes for psilocybin: clinical trials, the Special Access Program and individual exemptions under section 56(1), and says there are “no approved therapeutic products containing psilocybin in Canada or elsewhere” (Health Canada). That wording was unchanged when Health Canada updated the page on 20 October 2026.

How an FDA approval might interact with these routes, and with provincial coverage or professional rules, is not established in the sources we opened.

What we could not verify

• Whether any COMP360 submission has been made to Health Canada. We found none mentioned in the company filings we read (not established).
• Anything dated after 10 August 2026 from the company. The latest regulatory statements we could open are from 5 August 2026.
• The FDA’s own record of the status of the NDA. We found no FDA statement about COMP360 by name beyond the company’s voucher announcement; the FDA’s own release did not name the company.
• Whether Health Canada’s reliance order applies to psilocybin products (not established).
• Independent peer-reviewed publication of the phase 3 results. We relied on the sponsor’s filings.
• The DEA’s own position on rescheduling. We read it only as the company describes it.

Regulatory status can change within days. Check the date on this page, then go to the sources below. Next, read our plain-language explainer on psilocybin or the wider guide to what magic mushrooms are.

Shroomverse sells mushroom products. This article is general information about drug regulation and clinical research. It is not medical, legal, investment or purchasing advice, and it does not recommend any product.