Compass Pathways' psilocybin drug is in priority FDA review, and New York sites helped test it
The FDA agreed on April 24, 2026 to review Compass Pathways' synthetic psilocybin, COMP360, on a rolling basis and gave it a priority voucher that targets a one-to-two-month review once the application is complete. New York research sites helped run the trials behind it, but an approval wouldn't make it available here until federal and state drug schedules change too.
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Silver Spring, Md., April 24, 2026. The Food and Drug Administration said on April 24, 2026 that it was issuing national priority vouchers to three companies, one of them studying psilocybin for treatment-resistant depression.1 Compass Pathways said that day it was that company: the FDA had granted its request for a rolling review of its new drug application for COMP360, its synthetic psilocybin, and picked COMP360 for the Commissioner's National Priority Voucher program.2 The FDA says the program targets a review of one to two months, against six months or more under its other priority programs.3
Where the application stands
On August 5, Compass said some modules of the application were in, that it expected to finish the submission in the fourth quarter of 2026, and that it expected a commercial launch in the first half of 2027, "subject to FDA approval and following Drug Enforcement Administration (DEA) rescheduling."4 As of November 2, its SEC filings and press releases hadn't announced a completed submission. It reports third-quarter results on November 3.5, 6
The evidence behind it
The application rests on two phase 3 trials. Compass reports that in COMP005, a single 25 mg dose beat placebo by 3.6 points on the MADRS depression scale at week 6, and in COMP006, two 25 mg doses three weeks apart beat a 1 mg control by 3.8 points; both results had p<0.001. In July it said 39% of the 25 mg group in COMP006 had cut their MADRS score by at least 25% by week 6 and, on average, kept that benefit through at least week 26.7 These are company-reported figures, not yet in a peer-reviewed journal as far as we could find.
New York's part in the trials
| Trial | Status | New York sites |
|---|---|---|
| COMP001, phase 2 (NCT03775200) | Completed, 233 enrolled | New York State Psychiatric Institute |
| COMP005, phase 3 (NCT05624268) | Completed, 258 enrolled | New York State Psychiatric Institute; The Medical Research Network (2 of 40 sites) |
| COMP006, phase 3 (NCT05711940) | Active, not recruiting | New York State Psychiatric Institute; Fieve Clinical Research; Spectrum Neuroscience and Treatment Institute; Adams Clinical in Manhattan and the Bronx; Richmond Behavioral Associates, Staten Island; Dent Neurosciences Research Center, Amherst (7 of 116 sites) |
| COMP202 "Redefine," PTSD, phase 2b/3 (NCT07570654) | Recruiting, 300 planned | Two sites named only "NY": Manhattan (ZIP 10025) and the Bronx (ZIP 10461) |
Site lists come from the registry.8 The PTSD trial compares COMP360 25 mg, 10 mg and 1 mg; its primary outcome is the change in PTSD symptoms on the CAPS-5 scale at week 8.8 Our New York trials list tracks every psilocybin study with a site in the state.
What approval would and wouldn't change in New York
FDA approval alone wouldn't make COMP360 available. Psilocybin is in federal Schedule I,9 and an April 18, 2026 executive order tells the Attorney General, in consultation with HHS, to review Schedule I products that finish phase 3 trials for a serious mental health disorder, so that rescheduling of approved products, "if appropriate," can proceed "as quickly as practicable."10
New York keeps its own schedules. Under Public Health Law section 3307 as it stands, the state health commissioner must, by regulation or emergency regulation, reclassify or exempt a Schedule I compound that the federal government moves out of Schedule I. S9852, introduced April 8, 2026, would make that automatic on the federal effective date for the specific FDA-approved compound or preparation;11 we cover it in a separate post. Compass says about 90% of the U.S. patient population lives in states that intend to reschedule within 30 days of DEA action, without naming them.4 None of this covers psilocybin mushrooms; for the law on those, see is psilocybin legal in New York.
Sources
- FDA accelerates action on treatments for serious mental illness following executive order. FDA, April 24, 2026.
- Compass announces FDA granted NDA rolling review and national priority voucher. Compass Pathways, April 24, 2026.
- CNPV pilot program. FDA, current as of October 19, 2026.
- Second quarter 2026 results, Form 8-K Exhibit 99.1. Compass Pathways, August 5, 2026.
- Compass Pathways Form 8-K list. SEC EDGAR, checked November 2, 2026.
- Compass to announce third quarter 2026 results on November 3. Compass Pathways, October 27, 2026.
- Form 8-K, February 17, 2026 and Form 8-K, July 7, 2026. Compass Pathways.
- NCT07570654, NCT05711940, NCT05624268 and NCT03775200. ClinicalTrials.gov, read November 2, 2026.
- 21 CFR 1308.11(d)(29) and (30). eCFR, version of October 21, 2026.
- Executive Order 14401, section 5. 91 FR 21709, April 22, 2026.
- S9852 bill text. New York State Senate, April 8, 2026.
Keep reading
Can you get legal psilocybin therapy in NYC?Trials, Spravato and ketamine clinics, Oregon and Colorado: what's legal for New Yorkers now, and what isn't.
Which psilocybin clinical trials are recruiting in New York?Every psilocybin study with a New York site: who's recruiting at NYU Langone, Mount Sinai and the Bronx VA, and how screening works.
Are shrooms legal in New York?No: psilocybin is Schedule I in New York, any amount is a crime and nowhere in the state has decriminalized it.
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