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A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Combined Safety and Efficacy in Humans With Major Depressive Disorder

Trial Profile

A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Combined Safety and Efficacy in Humans With Major Depressive Disorder

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 27 May 2025

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At a glance

  • Drugs CYB 003 (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms APPROACH
  • Sponsors Cybin

Most Recent Events

  • 22 May 2025 According to a Cybin Inc. media release, company announces that Doug Drysdale, Cybi's Chief Executive Officer, will participate in a Water Tower Research Fireside Chat taking place on Thursday, May 29, 2025, at 11:00 a.m. ET. and will cover progress of the CYB003 phase 3 program.
  • 20 May 2025 Results presented in a Cybin Inc. media release
  • 20 May 2025 According to a Cybin Inc. media release, dosing continues in Phase 3 APPROACH study in MDD. 71% of participants receiving two doses of 16 mg were in remission.

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