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Psilocybin

Phase 3

Major Depressive Disorder | Small molecule | Psychiatry |COMPASS Pathways Plc - American Depository Shares|Last Updated: Aug 19, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment122
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06247839The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive DisorderPHASE3 RECRUITING 20 — — Sep 10, 2024Jun 30, 2026May 6, 20251 United States
NCT05733546A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive DisorderPHASE2 ACTIVE NOT_RECRUITING 102 — — Jan 30, 2023Sep 1, 2025Aug 19, 20255 United States
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Study Endpoints
Primary Endpoints
Change in Massachusetts General Hospital Rumination Questionnaire (MGH-RQ)
Baseline, and 3 weeks, 6 weeks, 9 weeks, and 12 weeks after psilocybin administration.

A transdiagnostic state measure of rumination over the previous two weeks consisting of 9 items on a 5 point Likert scale from 0 (Never/Rarely) to 4 (All The Time).

Change in Resting-State Functional Connectivity
Baseline, day of psilocybin administration, and 3 weeks, and 12 weeks after psilocybin administration.

Changes in resting-state activity during functional magnetic resonance imaging(fMRI) scans.

Change in Self-Attribution Task performance
Baseline, day of psilocybin administration, and 3 weeks, and 12 weeks after psilocybin administration.

Participants are shown words one at a time and asked to answer if each of the words apply to 'Self' or 'Other'.

Change in Task-Based Activity during Self-Attribution Task
Baseline, day of psilocybin administration, and 3 weeks, and 12 weeks after psilocybin administration.

Changes in activity in the default mode network during functional magnetic resonance imaging(fMRI) scans while participants perform a self-attribution task.

Safety and tolerability of COMP360 Psilocybin
Up to Week 6

Proportion of patients with adverse events (AEs)

Secondary Endpoints
Change in Montgomery-Asberg Depression Rating Scale(MADRS)
Baseline, the day before psilocybin administration and at 1 day, 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks and 12 weeks after psilocybin administration.
Change in Quick Inventory of Depressive Symptomatology Self Report - 16 item (QIDS-SR-16)
Baseline, the day before psilocybin administration and at 1 day, 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks and 12 weeks after psilocybin administration.
Change in Positive and Negative Affect Schedule (PANAS)
Baseline, the day of psilocybin administration and at 3 weeks and 12 weeks after psilocybin administration.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PsilocybinEXPERIMENTAL25mg Psilocybin
25 mg COMP360 PsilocybinEXPERIMENTAL25 mg COMP360 Psilocybin
10 mg COMP360 PsilocybinEXPERIMENTAL10 mg COMP360 Psilocybin
1 mg COMP360 PsilocybinACTIVE_COMPARATOR1 mg COMP360 Psilocybin
Interventions
NameTypeDescription
PsilocybinDRUGCOMP360 (Brand name of psilocybin to be used)
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Must be able to sign the informed consent form (ICF). Participants will demonstrate capacity to provide informed consent by demonstrated understanding of the protocol and what their involvement in the study requires from them. 2. Be 18-55 years of age at screening. 3. At leas...

Countries:United States
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Competitive Landscape -Major Depressive Disorder 91 trials
CompanyTickerTrialsLead PhaseDrugs
COMPASS Pathways Plc Sponsored ADRCMPS5PHASE3Psilocybin
Neurocrine Biosciences, Inc.NBIX5PHASE3NBI-1065845
Johnson & JohnsonJNJ4PHASE3Esketamine, Midazolam, Seltorexant, Selective Serotonin Reuptake Inhibitor /Serotonin-Norepinephrine Reuptake Inhibitor, JNJ-89495120
AbbVie, Inc.ABBV2PHASE3Cariprazine, Icalcaprant
Xenon Pharmaceuticals Inc.XENE3PHASE3Azetukalner
Axsome Therapeutics, Inc.AXSM2PHASE3Solriamfetol, Dextromethorphan-Bupropion
Neumora Therapeutics, Inc.NMRA3PHASE3NMRA-335140
Definium Therapeutics, Inc.DFTX2PHASE3MM120, DT120
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE3Vortioxetine
Eli Lilly and CompanyLLY1PHASE3Brenipatide
Cybin, Inc.HELP3PHASE3CYB003
Vanda Pharmaceuticals Inc.VNDA1PHASE3Milsaperidone
AtaiBeckley Inc.ATAI3PHASE2VLS-01-203 BU, BPL-003, ELE-101
ACADIA Pharmaceuticals Inc.ACAD1PHASE2ACP-211
Supernus Pharmaceuticals, Inc.SUPN1PHASE2SPN-821
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-300
Harvard Bioscience, Inc.HBIO2PHASE3Antidepressant medication
Seaport Therapeutics, Inc.SPTX2PHASE2SPT-300
Masimo CorporationMASI1PHASE1Diprivan , Astra-Zeneca
Abbott LaboratoriesABT1NAUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05733546primaryCompletionDate: changed
LOWMay 24, 2026NCT06247839studyFirstPostDate: changed
LOWMay 24, 2026NCT05733546studyFirstPostDate: changed