COMP360 psilocybin treatment in TRD
This page summarises results from COMPASS Pathways' phase 2b trial of investigational COMP360 psilocybin treatment for treatment-resistant depression. The study assessed three doses and reported a significant reduction in depressive symptoms after 25mg with psychological support.
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COMP360 psilocybin treatment in TRD presents results from a randomised controlled phase 2b study of investigational psilocybin treatment for treatment-resistant depression. According to the source page, the trial was the largest psilocybin treatment clinical trial ever conducted, with 233 patients across 22 sites in 10 countries across Europe and North America. The study assessed safety and efficacy across three doses: 1mg, 10mg, and 25mg. The published results reported that a single 25mg dose of COMP360 psilocybin, combined with psychological support, was associated with a statistically significant reduction in depressive symptoms after three weeks, with a rapid and durable response for up to 12 weeks. The content is informational and research-focused rather than a training course. It appears most relevant to clinicians, researchers, and others following clinical trial evidence in psychedelic medicine and treatment-resistant depression.
Who is this for?
Clinicians, researchers, and others interested in clinical trial evidence for psilocybin treatment in treatment-resistant depression.
About the Provider
COMPASS Pathways plc (Nasdaq: CMPS) is a UK-headquartered clinical-stage biopharmaceutical company and the most advanced developer of a classic psychedelic medicine. Its lead asset, COMP360 — a synthetic, proprietary formulation of psilocybin — is being developed for treatment-resistant depression (TRD) delivered alongside a psychological-support model. COMP360 is the first psilocybin programme to complete two positive pivotal Phase 3 trials: COMP005 met its primary endpoint in June 2025 and the confirmatory COMP006 (two fixed doses given three weeks apart) did so in February 2026, with 26-week data reported in July 2026 confirming a rapid and durable antidepressant profile. In April 2026 the FDA granted a rolling NDA submission request and selected COMP360 for the Commissioner's National Priority Voucher programme, which carries a shortened review window. COMPASS has since begun that rolling submission and guides to a potential US launch in the first half of 2027, subject to approval, positioning it as the frontrunner for the first FDA-approved classic psychedelic therapy.
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- PricePrice on request
- Lifecycle statusNo New Dates
- SkillsPsilocybin TherapyUnderstanding phase 2b clinical trial resultsInterpreting dose-response findingsAssessing reported safety and efficacy outcomesInterpreting dose-ranging study dataReviewing safety and efficacy findingsReading evidence on treatment-resistant depressionInterpret phase 2b clinical trial resultsReview dose-ranging study designUnderstand treatment-resistant depression researchAssess safety and efficacy findingsEvaluate outcomes with psychological supportInterpretation of clinical trial resultsUnderstanding dose-ranging study design
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