Compass Pathways Files Psilocybin Drug With FDA

The company has submitted a New Drug Application for COMP360 psilocybin as a treatment for treatment-resistant depression.

Updated on Nov. 9, 2026 in Mental Health

Compass Pathways Files Psilocybin Drug With FDA

Live Poll

Should psilocybin-based treatments be approved for treatment-resistant depression in the U.S.?

Compass Pathways completed its New Drug Application submission to the U.S. FDA for COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD). The application is supported by two Phase 3 trials and one Phase 2b study, all of which met their primary endpoints.

Why it matters

TRD affects an estimated 4 million people in the U.S., and fewer than 5% of them are currently on a TRD-indicated treatment. If approved, COMP360 would add a new option for a population with limited current choices.

The NDA rests on two Phase 3 trials and one Phase 2b study with more than 1,000 participants combined, all meeting primary endpoints. Fewer than 5% of an estimated 4 million U.S. patients with TRD currently receive a TRD-indicated treatment, and whether FDA review and scheduling decisions will clear the path to launch remains unresolved.

The players

Compass Pathways

A London-headquartered company developing psilocybin-based therapies, with a U.S. office in New Jersey, which submitted the application for COMP360.

U.S. Food and Drug Administration

The federal agency responsible for reviewing and approving new drug applications, which will determine whether COMP360 is approved for sale in the United States.

The details

Compass Pathways has a fully scaled commercial organization in place for launch, and it expects FDA review to continue following submission. The company also expects DEA and state rescheduling decisions to be required before commercialization in the United States.

November 9, 2026: Compass announces completion of the NDA submission to the FDA.
First half of 2027: Expected commercial launch of COMP360, subject to FDA approval.

Health Landscape

COMP360 carries Breakthrough Therapy designation from the FDA, placing its application within the agency's expedited pathway for serious conditions. The submission follows a broader push to bring psychedelic-derived treatments into the mainstream of psychiatric care for patients with few existing options.

If approved, COMP360 would offer a new treatment option for people with treatment-resistant depression who are not currently on a TRD-indicated therapy. Patients and families would still need DEA and state rescheduling decisions to be finalized before the drug could be commercially available in the United States.

The takeaway

Treatment-resistant depression affects millions of Americans, and a regulatory decision on COMP360 will determine whether a psilocybin-based option becomes available. Readers tracking mental health care should watch for FDA action and scheduling decisions over the coming year.

What happens next

The FDA review process is expected to continue following submission, with a commercial launch targeted for the first half of 2027 subject to approval.