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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: 20 Aug 2026

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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

  • 07 Jul 2026 According to a Compass Pathways media release, company anticipates the launch of COMP360 in the first half of 2027 subject to FDA approval and following Drug Enforcement Administration (DEA) rescheduling.
  • 07 Jul 2026 According to a Compass Pathways media release, A rolling New Drug Application (NDA) submission and initial review with the U.S. Food and Drug Administration (FDA) is underway and final submission remains on track to be completed in Q4, 2026.
  • 07 Jul 2026 Results (26-week results (PartB)) presented in a COMPASS Pathways Media Release.

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