The first psilocybin medicine could arrive in 2027. What it would and wouldn't change in Washington

For the first time, an FDA decision on a psilocybin drug looks close. Compass Pathways said in August that it expects to finish submitting its application for COMP360, a synthetic psilocybin treatment for treatment-resistant depression, in the fourth quarter of 2026, and it's targeting a commercial launch in the first half of 2027.

How it got here

• Two Phase 3 trials. COMP005, with 258 participants, met its primary goal in June 2025. COMP006, with 581, met its primary goal in February 2026. In both, depression scores fell more with COMP360 than in the comparison group at the main measurement point, and Compass reported in August that participants who had a meaningful response by week 6 kept that benefit, on average, through at least week 26.
• A faster review. In April 2026, the FDA awarded COMP360 a Commissioner's National Priority Voucher. Compass says that could cut the review to one to two months once the application is complete, while cautioning that it may not.
• Political backing. Executive Order 14401, signed April 18, 2026, directed the FDA to give priority vouchers to psychedelic drugs with Breakthrough Therapy designation, told the FDA and DEA to set up a Right to Try pathway that explicitly includes ibogaine, committed at least $50 million through ARPA-H to states with psychedelic programs, and directed a review so that products completing Phase 3 can be rescheduled quickly once approved.

The DEA step

Psilocybin is still a Schedule I drug, defined as having no accepted medical use. An approved product would have to be rescheduled before it could be prescribed, which is why Compass's launch target is conditional on DEA action. Separately, the DEA sent a petition to reschedule psilocybin itself to the Department of Health and Human Services for review in August 2025; we found no public recommendation on it as of October 2026.

What it would change in Washington

Washington's controlled substances law generally follows federal changes automatically: when the federal government reschedules a substance, the state Pharmacy Quality Assurance Commission must do the same after 30 days unless someone objects (RCW 69.50.201). So an approved, rescheduled COMP360 could become a legal prescription treatment here without a vote of the Legislature.

What it would look like: a specific synthetic psilocybin product, given in a clinic to patients with treatment-resistant depression, with monitoring during the session, similar to how esketamine (Spravato) is used now. Cost and insurance coverage are open questions.

What it wouldn't change

Approval of one product wouldn't make psilocybin mushrooms legal, in Washington or anywhere. Possessing, growing or selling mushrooms would still be governed by state law and Schedule I. Seattle's 2021 low-priority resolution would still be the city's only policy on personal use. Our Seattle law guide explains where that stands.

Others in line

Compass isn't alone. Definium Therapeutics, formerly MindMed, reported positive Phase 3 results for its LSD-based drug in depression in August and in generalized anxiety in August and September, and plans to file in the first half of 2027. The VA and HHS signed a psychedelic research agreement in July 2026, and VA Puget Sound in Seattle is one of the sites in a new Phase 3 VA trial of psilocybin for veterans with treatment-resistant depression, which began recruiting in August.

Last checked against the sources above on Oct 20, 2026. Spotted something out of date? Tell us.