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Optimi to Initiate Canada Phase 3 MDMA PTSD Trial in 2027

Sep 16, 2026, 8:28 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Phase 3 initiation signals potential long-run value if trial data are favorable; historically, successful CNS/psychedelics trials can unlock stock upside, though timelines are multi-year and outcomes uncertain.

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What happened, with direct paths to the underlying reporting

Optimi Health announced a Health Canada‑authorized Phase 3 MDMA‑assisted therapy trial for PTSD, expected to begin in 2027 with up to 100 participants across Canada, targeting veterans and frontline workers. The study uses two MDMA dosage formats and CAPS-5 as the primary endpoint, potentially advancing toward regulatory registration if results are positive. The development follows earlier psilocybin work and ongoing international regulatory activity.

Optimi to start Health Canada Phase 3 MDMA-PTSD trial in 2027.
Up to 100 participants across Canada, focusing on veterans, frontline workers.
Primary endpoint: CAPS-5; two MDMA dosage formats; two psychotherapy sessions.
Australia clinics have prescribed Optimi MDMA since Oct 2024, signaling validation.

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