Asset profile

Psilocybin (COMP360)

Small molecule

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Reliablesignal

Evidence outlook · lead readout

NCT05624268 · Treatment Resistant Depression

The completed lead evidence has the design features that historically survive confirmatory trials: randomized, controlled, and adequately powered against a prespecified clinically accepted endpoint.

NCT05624268: This was a randomized, quadruple-blind, placebo-controlled trial with 258 participants, using change in a standard clinician-rated depression scale as the primary measure. The sponsor reports a statistically significant difference favoring COMP360 over placebo at week 6.

Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.

Also in development:Post-Traumatic Stress Disorder · Phase 3

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Competitive landscape

66 competitors in this universe: 7 direct rivals (same mechanism and indication), 0 same-class, 59 same-indication; 9 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Psilocybin (COMP360): this drugPhase 3Small molecule5-HT2A receptor
CYB003Phase 3Small molecule5-HT2A receptor
Lysergide Tartrate (LSD) (DT120)Phase 3Small molecule5-HT2A receptor
BPL-003 (mebufotenin Benzoate)Phase 2Small molecule5-HT2A receptor
BretisilocinPhase 2Small molecule5-HT2A receptor
Mebufotenin (5-MeO-DMT) (GH001)Phase 2Small molecule5-HT2A receptor
VLS-01Phase 2Small molecule5-HT2A receptor
ELE-101Phase 1/2Small molecule5-HT2A receptor
Brexpiprazole (Rexulti)ApprovedSmall moleculeDopamine D2/D3 and serotonin 5-HT1A receptor
Cariprazine (Vraylar)ApprovedSmall moleculeDopamine D3/D2 receptor (partial agonist)
Cyclobenzaprine (Tonmya)ApprovedSmall molecule5-HT2A, α1-adrenergic, H1-histaminergic, and M1-muscarinic acetylcholine receptors (functional antagonism)
Dextromethorphan / Bupropion (Auvelity)ApprovedSmall moleculesigma-1/NMDA
Esketamine (Spravato)ApprovedSmall moleculeNMDA receptor
Lumateperone (Caplyta)ApprovedSmall moleculeSerotonin 5-HT2A / dopamine D1-D2 receptor
Olanzapine / Fluoxetine (Symbyax)ApprovedSmall moleculeDopamine D2 and serotonin 5-HT2A receptors (antagonist); serotonin transporter (reuptake inhibitor)
Solriamfetol (Sunosi)ApprovedSmall moleculeDopamine/norepinephrine transporter

…and 51 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(48 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (5)
December 2026 (5)
Phase 1Major Depressive DisorderActive not recruiting
Est. primary completion 2026-12 · NCT06731621 · CT.gov ↗
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Phase 1Breast Cancer, Ovarian CancerRecruiting
Est. primary completion 2026-12 · NCT06430541 · CT.gov ↗
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Phase 2Major Depressive DisorderRecruiting
Est. primary completion 2026-12 · NCT06319378 · CT.gov ↗
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Phase 1Post-Traumatic Stress DisorderRecruiting
Est. primary completion 2026-12-01 · NCT07737054 · CT.gov ↗
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Phase 2Adjustment Disorder, Adjustment Disorder With Anxious Mood, Cancer, Cancer Cachexia, Cancer of Endometrium, Cancer of Kidney …Recruiting
Est. primary completion 2026-12-30 · NCT07072728 · CT.gov ↗
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2027 (16)
January 2027 (1)
Phase 2Major Depressive DisorderRecruiting
Est. primary completion 2027-01-01 · NCT06782724 · CT.gov ↗
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February 2027 (1)
Phase 1Stroke, Chronic Stroke, Intracerebral Haemorrhage, Intracerebral Haemorrhage (ICH), Intracerebral Hemorrhage Basal Ganglia …Recruiting
Est. primary completion 2027-02 · NCT07053917 · CT.gov ↗
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March 2027 (1)
Phase 2Major Depressive DisorderRecruiting
Est. primary completion 2027-03 · NCT06518720 · CT.gov ↗
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April 2027 (2)
Phase 2Major Depressive DisorderRecruiting
Est. primary completion 2027-04 · NCT06512220 · CT.gov ↗
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Phase 2Major Depressive DisorderActive not recruiting
Est. primary completion 2027-04-30 · NCT05947383 · CT.gov ↗
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June 2027 (2)
Phase 2Parkinson Disease, DepressionRecruiting
Est. primary completion 2027-06 · NCT06455293 · CT.gov ↗
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Phase 2Major Depressive DisorderRecruiting
Est. primary completion 2027-06-01 · NCT07183748 · CT.gov ↗
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July 2027 (1)
Phase 2Major Depressive DisorderNot yet recruiting
Est. primary completion 2027-07 · NCT07479550 · CT.gov ↗
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August 2027 (1)
Phase 1Healthy AdultsRecruiting
Est. primary completion 2027-08-01 · NCT07732166 · CT.gov ↗
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October 2027 (3)
Phase 1Smokers With Chronic PainRecruiting
Est. primary completion 2027-10-01 · NCT07118332 · CT.gov ↗
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Phase 3Major Depressive DisorderRecruiting
Est. primary completion 2027-10-22 · NCT07703722 · CT.gov ↗
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Phase 2Lung Non-Small Cell Carcinoma, Unipolar DepressionRecruiting
Est. primary completion 2027-10-31 · NCT07216404 · CT.gov ↗
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November 2027 (1)
Phase 1/2Major Depressive DiorderRecruiting
Est. primary completion 2027-11-30 · NCT07281352 · CT.gov ↗
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December 2027 (3)
Phase 1Major Depressive DisorderRecruiting
Est. primary completion 2027-12 · NCT06442423 · CT.gov ↗
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Phase 1Chronic Pelvic PainRecruiting
Est. primary completion 2027-12-31 · NCT06988319 · CT.gov ↗
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Phase 2Generalized Anxiety Disorder (GAD)Recruiting
Est. primary completion 2027-12-31 · NCT06969170 · CT.gov ↗
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2028 (14)
March 2028 (4)
Phase 1Healthy Volunteer, Older Adults (65-85 Years)Recruiting
Est. primary completion 2028-03 · NCT07516405 · CT.gov ↗
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Phase 2Major Depressive DisorderNot yet recruiting
Est. primary completion 2028-03 · NCT07405606 · CT.gov ↗
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Phase 1/2Major Depressive DisorderRecruiting
Est. primary completion 2028-03-01 · NCT07251491 · CT.gov ↗
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Phase 2Major Depressive DisorderRecruiting
Est. primary completion 2028-03-01 · NCT06592833 · CT.gov ↗
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April 2028 (1)
Phase 1Aging, Longevity, Biomarkers of AgingNot yet recruiting
Est. primary completion 2028-04 · NCT07719088 · CT.gov ↗
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May 2028 (2)
Phase 2Major Depressive DisorderRecruiting
Est. primary completion 2028-05 · NCT06072898 · CT.gov ↗
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Phase 1Major Depressive DisorderRecruiting
Est. primary completion 2028-05-31 · NCT07490353 · CT.gov ↗
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June 2028 (1)
Phase 3Major Depressive DisorderRecruiting
Est. primary completion 2028-06-30 · NCT06247839 · CT.gov ↗
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July 2028 (2)
Phase 2Major Depressive DisorderNot yet recruiting
Est. primary completion 2028-07 · NCT07373535 · CT.gov ↗
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Phase 2Major Depressive DisorderRecruiting
Est. primary completion 2028-07 · NCT07211438 · CT.gov ↗
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September 2028 (1)
Phase 1Healthy Participants, Placebo - Control, PsilocybinNot yet recruiting
Est. primary completion 2028-09-01 · NCT07433452 · CT.gov ↗
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November 2028 (1)
Phase 2/3PTSD - Post Traumatic Stress Disorder, PTSD, PTSD Symptoms, PTSD, Post Traumatic Stress DisorderRecruiting
Est. primary completion 2028-11 · NCT07570654 · CT.gov ↗
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December 2028 (2)
Phase 2Major Depressive DisorderNot yet recruiting
Est. primary completion 2028-12 · NCT07566104 · CT.gov ↗
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Phase 3Bipolar II DepressionNot yet recruiting
Est. primary completion 2028-12 · NCT06943573 · CT.gov ↗
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2029 (7)
January 2029 (1)
Phase 2Psilocybin, NeuropathyNot yet recruiting
Est. primary completion 2029-01-31 · NCT07227909 · CT.gov ↗
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April 2029 (2)
Phase 1Pain Management, Postoperative PainNot yet recruiting
Est. primary completion 2029-04 · NCT07406828 · CT.gov ↗
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Phase 2Methamphetamine Use Disorder, Human Immunodeficiency Virus (HIV)Not yet recruiting
Est. primary completion 2029-04 · NCT07756736 · CT.gov ↗
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September 2029 (1)
Phase 2Major Depressive DisorderRecruiting
Est. primary completion 2029-09 · NCT07104916 · CT.gov ↗
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December 2029 (3)
Phase 2Major Depressive DisorderRecruiting
Est. primary completion 2029-12-31 · NCT06132178 · CT.gov ↗
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Phase 2Major Depressive DisorderNot yet recruiting
Est. primary completion 2029-12-31 · NCT07210112 · CT.gov ↗
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Early phase / not applicableMajor Depressive DisorderEnrolling by invitation
Est. primary completion 2029-12-31 · NCT07737990 · CT.gov ↗
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2030 (4)
February 2030 (1)
Phase 1Anhedonia in Healthy Volunteers, Older Adults (50-90 Years)Recruiting
Est. primary completion 2030-02 · NCT07386730 · CT.gov ↗
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June 2030 (1)
Phase 2Major Depressive DisorderNot yet recruiting
Est. primary completion 2030-06-30 · NCT07745569 · CT.gov ↗
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July 2030 (1)
Phase 2Depression, Parkinson's Disease (PD)Recruiting
Est. primary completion 2030-07 · NCT07610369 · CT.gov ↗
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December 2030 (1)
Phase 3Major Depressive DisorderRecruiting
Est. primary completion 2030-12-02 · NCT07226232 · CT.gov ↗
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2031 (2)
January 2031 (1)
Phase 1/2Major Depressive DisorderNot yet recruiting
Est. primary completion 2031-01-01 · NCT07499583 · CT.gov ↗
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June 2031 (1)
Phase 2DepressionNot yet recruiting
Est. primary completion 2031-06 · NCT07582120 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (9)
Phase 2/3 (1)
Phase 2 (57)
Phase 1/2 (5)
Phase 1 (20)
Early phase / not applicable (4)
Used as active comparator (1)
Appears in other studies (2)