Psilocybin research and FDA status in 2026
No psilocybin medicine is FDA-approved yet, but the first application is close. Compass Pathways expects to finish filing for COMP360 by the end of 2026 and is aiming for a 2027 launch, if the FDA approves it and the DEA reschedules it. Here's the state of the science and the approval process, including the results that didn't pan out.
On this page
- FDA-approved?
- Not yet. No psilocybin drug is approved in the U.S.
- Closest to approval
- Compass Pathways' COMP360 (synthetic psilocybin) for treatment-resistant depression; application due to be complete in the fourth quarter of 2026
- Also in Phase 3
- Usona Institute (psilocybin, major depression); Helus Pharma's HLP003, formerly Cybin's CYB003 (a psilocin analog)
- Federal schedule
- Schedule I; an approved product would need DEA rescheduling
- Last checked
- October 20, 2026
The FDA pipeline
Compass Pathways: COMP360
COMP360 is a synthetic form of psilocybin given in one or two supervised dosing sessions in trials. Compass has run two Phase 3 trials in treatment-resistant depression:
- COMP005 (258 participants): a single 25 mg dose beat placebo by 3.6 points on the MADRS depression scale at week 6. Results were announced in June 2025.
- COMP006 (581 participants): two 25 mg doses three weeks apart beat a 1 mg control by 3.8 points at week 6, announced in February 2026. Serious adverse events over 26 weeks were similar between groups (5.7% vs 6.3%).
These are company-reported topline results; neither trial had been published in a peer-reviewed journal as of October 2026. On April 24, 2026, the FDA granted Compass a rolling review and a Commissioner's National Priority Voucher, which can shorten review to one or two months after filing. Usona and Transcend Therapeutics (methylone, for PTSD) got vouchers the same day. Compass says it will finish its application this quarter and is targeting a U.S. launch in the first half of 2027, "subject to FDA approval and DEA rescheduling." It expects the drug to be given in roughly 8,500 interventional psychiatry clinics, with a safety program (REMS). Full timeline.
Usona Institute
Usona's uAspire Phase 3 trial of psilocybin for major depressive disorder finished enrolling 238 people in November 2025. Usona holds Breakthrough Therapy designation and a priority voucher, but had not announced topline results or a filing date as of October 2026.
Helus Pharma (formerly Cybin)
Helus finished enrolling its first Phase 3 trial of HLP003, a deuterated psilocin analog formerly called CYB003, in July 2026, with topline results expected in the fourth quarter of 2026. It refers to a potential FDA application in 2028.
What Washington changed in 2026
- Executive Order 14401 (April 18, 2026) directs priority vouchers for breakthrough psychedelic drugs, asks the FDA and DEA to set up a Right to Try pathway, directs at least $50 million through ARPA-H for state partnerships, and tells the Attorney General to review Phase 3-complete Schedule I drugs for rescheduling once approved. It doesn't name psilocybin.
- The FDA's framework. In September 2026, FDA drug-review leaders published a framework in The New England Journal of Medicine accepting new trial designs and flagging a likely safety program for approved psychedelics. The FDA held its first public hearing on psychedelic therapy on September 14. Read more.
- The VA launched PIVOT, a five-site psilocybin trial for veterans with treatment-resistant depression, in August 2026. Read more.
What recent trials found
The research picture is encouraging but mixed, and the honest summary includes the studies that missed.
| Condition | Study | What it found |
|---|---|---|
| Smoking | Johns Hopkins, JAMA Network Open, March 2026 (82 people) | 40.5% verified abstinent at 6 months with psilocybin plus therapy vs 10% with a nicotine patch plus therapy |
| Cocaine use | UAB, JAMA Network Open, May 2026 (40 people) | More cocaine-free days and lower relapse risk over 180 days than the control |
| Treatment-resistant depression | King's College London, Nature Medicine, August 2026 (60 people) | Large improvement vs placebo at 3 and 6 weeks; most placebo patients guessed their group, which may inflate the gap |
| Treatment-resistant depression | EPISODE trial, JAMA Psychiatry, May 2026 (144 people) | Missed its main goal: 17% vs 10.6% response, not statistically significant |
| Major depression | Karolinska, JAMA Network Open, May 2026 (35 people) | Clear benefit at 1 and 6 weeks that faded by 1 year |
| Alcohol use | Zurich, eClinicalMedicine, March 2025 (37 people) | A single dose after withdrawal did not reduce relapse vs placebo |
| Anorexia | Imperial College, British Journal of Psychiatry, July 2026 (21 women) | 48% had non-clinical eating-disorder scores at 3 months; weight didn't change meaningfully; no control group |
| Real-world use | OHSU, JAMA Network Open, August 2026 (about 346 people) | More than half of Oregon service-center clients reported improvement; 4 serious adverse reactions; uncontrolled |
Two cautions run through the field. Psilocybin's effects are hard to hide, so many participants know whether they got the drug, which can exaggerate benefits. And a 2025 analysis in JAMA Network Open found that control groups in psilocybin trials improved much less than those in antidepressant trials, suggesting effect sizes "might" be overestimated. For microdosing specifically, see our microdosing research review.
What approval would and wouldn't mean
- It would make one specific product, synthetic psilocybin, available by prescription in certified clinics, with on-site monitoring.
- It wouldn't legalize mushrooms, home use or retail sales. Psilocybin mushrooms would stay Schedule I unless separately rescheduled.
- States with trigger laws, including Arizona, Colorado, Georgia, Mississippi, South Dakota, Virginia and West Virginia, have already lined up to allow prescriptions quickly once the DEA acts.
Want to take part in research now? See psilocybin therapy near me for how to find recruiting trials.
Frequently asked questions
Is psilocybin FDA approved?
No. As of October 2026, no psilocybin product is FDA-approved. Compass Pathways expects to complete its application for COMP360 in late 2026 and is targeting a 2027 launch, which depends on FDA approval and DEA rescheduling.
When will psilocybin therapy be available by prescription?
The earliest realistic date is 2027. Compass has guided to a launch in the first half of 2027 if approved. Treatment would happen in certified clinics with monitoring for several hours, not at home.
Does psilocybin work for depression?
Large trials show a statistically significant but moderate benefit over control for treatment-resistant depression, and some smaller trials show larger effects. Others, including Germany's EPISODE trial, missed their main goals, and blinding problems may inflate results. It isn't a proven cure.
Will FDA approval make magic mushrooms legal?
No. Approval would cover a specific synthetic product prescribed in clinics. Psilocybin mushrooms would remain a Schedule I drug federally, and state laws on mushrooms wouldn't change automatically.
Sources
- Compass Pathways COMP005 results, SEC filing, June 23, 2025.
- Compass achieves primary endpoint in second Phase 3 trial, Compass Pathways, February 17, 2026.
- Compass announces six-month data from second Phase 3 trial, Business Wire, July 7, 2026.
- Compass Pathways second-quarter 2026 results, SEC filing, August 5, 2026.
- Compass, Usona score FDA national priority vouchers, Fierce Biotech, April 24, 2026.
- Compass CEO on COMP360 launch plans, BioPharma Dive, September 21, 2026.
- Compass Pathways at the STAT Summit, STAT, October 14, 2026.
- uAspire Phase 3 (NCT06308653), ClinicalTrials.gov, updated July 23, 2026.
- Helus Pharma completes enrollment in Phase 3 APPROACH study, BioSpace, July 21, 2026.
- Executive Order 14401, Federal Register, April 22, 2026.
- Psilocybin vs nicotine patch for smoking cessation, JAMA Network Open, March 2026.
- Psilocybin for cocaine use disorder, JAMA Network Open, May 2026.
- Psilocybin for treatment-resistant depression in the NHS, Nature Medicine, August 2026.
- EPISODE trial, JAMA Psychiatry, May 2026.
- Psilocybin for major depression, one-year follow-up, JAMA Network Open, May 2026.
- Psilocybin for alcohol use disorder relapse prevention, eClinicalMedicine, March 2025.
- Psilocybin therapy for anorexia nervosa, British Journal of Psychiatry, July 2026.
- Study of Oregon's legal mushroom experiment shows promise, OPB, August 19, 2026.
- Control-group response in psilocybin trials, JAMA Network Open, July 2025.