Norshroom

Psilocybin research tracker

No psilocybin drug is FDA-approved yet, but the first application is nearly complete. This tracker follows the programs that could change that, and the published trials that got them here.

By Norshroom EditorsUpdated

The drug pipeline

These are the psilocybin and psilocybin-like drugs in late-stage development in the United States. A Phase 3 trial is the last stage before a company asks the FDA for approval.

Drug and sponsorConditionStageLatest result or status
COMP360 (synthetic psilocybin), Compass PathwaysTreatment-resistant depressionPhase 3 complete (COMP005, COMP006); FDA application in progressBoth Phase 3 trials met their main goal. Final part of the application expected in the fourth quarter of 2026; Compass targets a launch in the first half of 2027.1,2,4
Psilocybin, Usona Institute (nonprofit)Major depressive disorderPhase 3 (uAspire, 238 enrolled)Main data collection finished January 2026. No results published yet.6 Trade press reported a priority review voucher in April 2026.7
HLP003, formerly CYB003, Helus Pharma (formerly Cybin)Major depression, added to an antidepressantPhase 3 (APPROACH, EMBRACE)APPROACH finished enrolling 223 people in July 2026, with results expected late 2026; the company targets an application in 2028.8,9 HLP003 is a modified form of psilocin, not psilocybin itself.
Psilocybin, U.S. Department of Veterans AffairsTreatment-resistant depression in veterans, with or without PTSDPhase 3 (PIVOT), recruitingStarted August 2026 at sites in Alabama, Oregon, Pennsylvania and Washington. Compares two dose levels, with no placebo. Main data collection expected to finish in December 2030.10

COMP360: closest to approval

Compass Pathways has completed two Phase 3 trials. In COMP005, 258 people with treatment-resistant depression received one dose of COMP360 or a placebo. Six weeks later, the psilocybin group scored 3.6 points lower on the MADRS, a standard 60-point depression scale.1 COMP006, with 581 people dosed, compared two administrations of COMP360 against a very low dose and found a 3.8-point difference at six weeks.2 That gap held through week 26, and serious side effects were similar across arms (5.7% and 6.3%).3

Those differences are statistically clear but smaller than in earlier, smaller studies. In April 2026 the FDA agreed to review Compass's application in pieces as they arrive and gave the drug a priority voucher meant to shorten the final review to one or two months.5 Approval would not by itself make the drug available: the DEA would also need to move it out of Schedule I.4

Results published in 2025 and 2026

Recent trials have been more mixed than the headlines suggest. Taken together, they point to real effects for some conditions and some people, with open questions about how long they last and how well trials can hide who got the drug.

StudyCondition and sizeWhat it found
Rucker et al., Nature Medicine, Aug 2026Treatment-resistant depression; 60 people, placebo-controlledA 10.4-point MADRS advantage at week 3 that held at week 6. Designed to test feasibility, so a larger trial is needed.11
EPISODE, JAMA Psychiatry, 2026Treatment-resistant depression; 144 people, active placeboMissed its main goal: 17.0% responded on psilocybin vs 10.6% on placebo, not a statistically significant difference. One person developed persisting visual changes (HPPD).12
Yngwe et al., JAMA Network Open, 2026Major depression; 35 peopleBeat placebo at days 8, 15 and 42; the difference had faded by one year.13
Hendricks et al., JAMA Network Open, 2026Cocaine use disorder; 40 peopleMore drug-free days over six months and a lower risk of relapse; no serious side effects.14
Johnson et al., JAMA Network Open, 2026Smoking; 82 people, compared with the nicotine patch40.5% stayed off cigarettes for six months after one psilocybin session, vs 10.0% with the patch. Not blinded; a pilot.15
Rieser et al., eClinicalMedicine, 2025Alcohol use disorder after detox; 37 peopleNo difference from placebo in drinking at four weeks or six months.16
Korthuis et al., JAMA Network Open, 2026Clients of Oregon's licensed service centers; 346 people, no control groupDepression, anxiety and PTSD symptoms were lower three months later; 1.2% had a reaction needing medical attention.17

A 2026 review of 112 trials of psychedelics and ketamine (11 of them psilocybin) found that fewer than a third checked whether participants could tell which treatment they got, and psilocybin studies often reported that most could.18 That makes the placebo comparison harder to interpret, and it's one reason the FDA's final guidance, issued in July 2026, asks for longer double-blind designs for chronic conditions.30

The studies that built the field

StudyDesignMain finding
Griffiths et al., 200636 healthy volunteers, double-blindTwo months later, participants rated the session as having substantial personal meaning and spiritual significance, with lasting positive changes that people close to them also noticed.19
Johnson et al., 201415 smokers, open-label pilot12 of 15 were not smoking six months later.26
Griffiths et al. and Ross et al., 201651 and 29 people with cancer, double-blind crossoverLarge, lasting drops in depression and anxiety; most still improved at six months.20,21
Davis et al., 202127 people with major depression, waitlist controlRapid, large improvement compared with people waiting for treatment.27
Carhart-Harris et al., 202159 people with depression; psilocybin vs the antidepressant escitalopramNo significant difference on the main measure at six weeks.22
Bogenschutz et al., 202295 people with alcohol use disorderHeavy drinking days fell to 9.7% with psilocybin vs 23.6% with an active placebo.24
Goodwin et al., 2022233 people with treatment-resistant depression, three dose levelsThe highest dose beat a very low dose at three weeks; the middle dose did not.23
Raison et al., 2023104 people with major depression (Usona)A 12.3-point MADRS advantage over placebo at six weeks.25
Peck et al., 202310 women with anorexia nervosa, open-labelA safety study: well tolerated, with no meaningful heart or suicidality changes.28

What regulators are doing

In 2026 the FDA finalized guidance on how psychedelic trials should be run30 and held a public hearing on how approved psychedelic treatments might be delivered, covering provider training, patient safety and access.29 The hearing didn't address legalization or any specific drug application. For the policy side, see what Executive Order 14401 does.

None of this changes the legal status of psilocybin mushrooms, which remain Schedule I. State-level changes are tracked on our legal status map.

Sources

  1. Compass Pathways, Form 8-K: COMP005 topline results, June 23, 2025. sec.gov
  2. Compass Pathways, "Successfully Achieves Primary Endpoint in Second Phase 3 Trial," February 17, 2026. ir.compasspathways.com
  3. Compass Pathways, six-month COMP006 data, July 7, 2026. s204.q4cdn.com
  4. Compass Pathways, Q2 2026 financial results and business update, August 5, 2026. sec.gov
  5. Compass Pathways, FDA rolling review and Commissioner's National Priority Voucher, April 24, 2026. s204.q4cdn.com
  6. ClinicalTrials.gov, NCT06308653 (Usona uAspire Phase 3). clinicaltrials.gov
  7. Managed Healthcare Executive, "FDA grants priority vouchers to 3 psychedelic medications," April 2026. managedhealthcareexecutive.com
  8. Helus Pharma, "Completes Enrollment in Phase 3 APPROACH Study of HLP003," July 21, 2026. biospace.com
  9. ClinicalTrials.gov, NCT06793397 (Helus EMBRACE Phase 3). clinicaltrials.gov
  10. ClinicalTrials.gov, NCT07226232 (VA PIVOT Phase 3). clinicaltrials.gov
  11. Rucker JJ et al. Nature Medicine 2026;32(9):3430-3437. doi:10.1038/s41591-026-04541-0. pubmed.ncbi.nlm.nih.gov
  12. Mertens LJ et al. (EPISODE trial). JAMA Psychiatry 2026. doi:10.1001/jamapsychiatry.2026.0132. pubmed.ncbi.nlm.nih.gov
  13. Yngwe et al. JAMA Network Open 2026. doi:10.1001/jamanetworkopen.2026.12589. pubmed.ncbi.nlm.nih.gov
  14. Hendricks PS et al. JAMA Network Open 2026. doi:10.1001/jamanetworkopen.2026.11029. pubmed.ncbi.nlm.nih.gov
  15. Johnson MW et al. JAMA Network Open 2026. doi:10.1001/jamanetworkopen.2026.0972. pubmed.ncbi.nlm.nih.gov
  16. Rieser NM et al. eClinicalMedicine 2025. doi:10.1016/j.eclinm.2025.103149. pubmed.ncbi.nlm.nih.gov
  17. Korthuis PT et al. JAMA Network Open 2026. doi:10.1001/jamanetworkopen.2026.30608. pubmed.ncbi.nlm.nih.gov
  18. Orsini et al. Blinding in psychedelic trials, systematic review. JAMA Psychiatry 2026. doi:10.1001/jamapsychiatry.2026.0255. pubmed.ncbi.nlm.nih.gov
  19. Griffiths RR et al. Psychopharmacology 2006;187(3):268-283. doi:10.1007/s00213-006-0457-5. pubmed.ncbi.nlm.nih.gov
  20. Griffiths RR et al. Journal of Psychopharmacology 2016;30(12):1181-1197. doi:10.1177/0269881116675513. pubmed.ncbi.nlm.nih.gov
  21. Ross S et al. Journal of Psychopharmacology 2016;30(12):1165-1180. doi:10.1177/0269881116675512. pubmed.ncbi.nlm.nih.gov
  22. Carhart-Harris R et al. New England Journal of Medicine 2021;384(15):1402-1411. doi:10.1056/NEJMoa2032994. pubmed.ncbi.nlm.nih.gov
  23. Goodwin GM et al. New England Journal of Medicine 2022;387(18):1637-1648. doi:10.1056/NEJMoa2206443. pubmed.ncbi.nlm.nih.gov
  24. Bogenschutz MP et al. JAMA Psychiatry 2022;79(10):953-962. doi:10.1001/jamapsychiatry.2022.2096. pubmed.ncbi.nlm.nih.gov
  25. Raison CL et al. JAMA 2023;330(9):843-853. doi:10.1001/jama.2023.14530. pubmed.ncbi.nlm.nih.gov
  26. Johnson MW et al. Journal of Psychopharmacology 2014;28(11):983-992. doi:10.1177/0269881114548296. pubmed.ncbi.nlm.nih.gov
  27. Davis AK et al. JAMA Psychiatry 2021;78(5):481-489. doi:10.1001/jamapsychiatry.2020.3285. pubmed.ncbi.nlm.nih.gov
  28. Peck SK et al. Nature Medicine 2023;29(8):1947-1953. doi:10.1038/s41591-023-02455-9. pubmed.ncbi.nlm.nih.gov
  29. U.S. Food and Drug Administration, public hearing on potential future therapeutic use of psychedelic drugs, September 14, 2026. fda.gov
  30. King & Spalding, "FDA's New Psychedelic Drug Guidance Paves a Path to Approval While Setting a High Evidentiary Bar," July 2026. kslaw.com