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NCT05711940Phase 3ACTIVE NOT RECRUITING

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD

Study Summary

Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)

Conditions
Treatment Resistant Depression
Interventions / Drugs
Psilocybin
View on ClinicalTrials.gov ↗
Sponsor
CMPS
COMPASS Pathways
Mental Health
D41/100
Study Details
Enrollment572 participants
Primary Completion—
Lead SponsorCOMPASS Pathways
Data Retrieved2026-04-11 04:09:48.956140+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 572 participants
Sponsor Catalyst Profile

COMPASS Pathways (CMPS) is the sponsoring company for this trial. BiotechSign currently grades this company D (41/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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Not financial advice. BiotechSign data is sourced from ClinicalTrials.gov, SEC EDGAR, and other public databases for research and informational purposes only. It does not constitute investment recommendations. Always do your own due diligence before making investment decisions.