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A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression

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Trial Profile

A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Nov 2025

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At a glance

  • Drugs Psilocybin (Primary)
  • Indications Treatment-resistant depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms COMP 006
  • Sponsors COMPASS Pathways

Most Recent Events

  • 10 Nov 2025 Status changed from recruiting to active, no longer recruiting.
  • 05 Nov 2025 According to an Atai Beckley media release, the ATAI Life Sciences has merged with Beckley Psytech to form Atai Beckley.
  • 04 Nov 2025 According to a Compass Pathways media release, Company accelerating commercialization readiness plans by 9-12 months, following completion of COMP006 trial enrollment and positive meeting with FDA on NDA submission strategies for COMP360 in TRD, including potential rolling submission. Company now plans to disclose 9-week data (Part A) from COMP006 in Q1 2026. Disclosure of 26-week (Part B) COMP006 data expected in early Q3 2026.

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