Compass says its psilocybin application to the FDA is complete. What happens next in Washington

An application to sell a psilocybin medicine in the United States is now in the FDA's hands. Compass Pathways announced on November 9, 2026 that it has completed its New Drug Application for COMP360, a synthetic psilocybin given with psychological support, for treatment-resistant depression.

That's the company's announcement, and it leaves the main question open. Compass's statement doesn't say the FDA has accepted the application for review, and no decision date is public.

What's in the filing

Compass says the application rests on two Phase 3 trials and an earlier Phase 2b study, with more than 1,000 participants between them. Both Phase 3 trials had sites in Washington: the Seattle Neuropsychiatric Treatment Center for one, and Core Clinical Research in Everett for the other, according to their federal registry listings.

The company holds a national priority voucher from the FDA, part of a pilot the agency says is meant to speed review of certain drugs. Compass told investors on November 3 that the voucher could shorten review to one or two months, and cautioned in the same release that it might not. It is still aiming to launch in the first half of 2027 if the drug is approved.

Two more steps after any approval

Psilocybin sits in Schedule I, the federal category for drugs with no accepted medical use. So an approved product can't be prescribed until the DEA moves it to a lower schedule. Compass says in its announcement that the timing of that step is uncertain.

Then the states. Washington's law is built to follow the federal government here: when a substance is rescheduled federally, the state's Pharmacy Quality Assurance Commission makes the same change after 30 days unless someone objects (RCW 69.50.201). No vote of the Legislature would be needed.

What it would look like in Seattle

If all of that happens, the result is one specific drug, for one diagnosis, taken in a clinic with staff present for the session. The closest thing available now is esketamine (Spravato), which is also given under supervision. What it will cost, which clinics will offer it and what insurers will cover are all unknown.

The VA is already testing the same drug locally. VA Puget Sound in Seattle is one of five sites recruiting veterans for a Phase 3 trial of COMP360 for treatment-resistant depression.

What it wouldn't do

It wouldn't make mushrooms legal. Approval covers a manufactured product with a prescription. Growing, possessing or selling psilocybin mushrooms would still fall under Washington's criminal law and Schedule I, and Seattle's 2021 resolution would still be the city's only entheogen-specific policy. Our Seattle law guide explains where that stands.

Compass may not be alone

A second filing may already be in. The trade publication Psychedelic Alpha reported on November 2, citing unnamed sources, that the nonprofit Usona Institute has completed its own application for psilocybin in major depressive disorder. Usona declined to comment to the publication, and nothing public confirms it. Usona's Phase 3 trial had a site in Bellevue, according to its registry listing.

We explained the road to this point in our October story on the FDA timeline, and we'll update this one when the FDA acts.

Last checked against the sources above on Nov 12, 2026. Spotted something out of date? Tell us.