New Phase 2 Clinical Trial Initiating in 2027: Evaluating Psilocybin-Assisted Therapy for Major Depressive Disorder

Optimi Health Corp has announced plans to initiate a multisite phase 2 clinical trial evaluating psilocybin-assisted therapy for individuals with major depressive disorder (MDD). The trial is planned to be initiated in the first half of 2027, with dosing expected to be complete by the end of 2027.

The phase 2 clinical trial is authorized to proceed by Health Canada and will enroll up to 200 participants across multiple sites in Canada, evaluating the safety and efficacy of a single supervised dose of natural psilocybin in the treatment of MDD. The primary efficacy endpoint is the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline.

"A 200-subject phase 2 trial in major depressive disorder is the largest clinical commitment Optimi has made to date. We will supply our own naturally derived psilocybin, manufactured at our GMP facility, and we will have exclusive ownership of the trial results," said Dane Stevens, the chief executive officer and cofounder of Optimi. "As we broaden our strategy to include clinical drug development, this phase 2 trial is an initial step toward potential registration. Few companies in this sector are commercial today while also advancing their own clinical development. In Canada, we already hold a Drug Establishment Licence and supply psilocybin through Health Canada's Special Access Program. This trial builds directly on that foundation, and we can comfortably fund it with current cash on hand."

This clinical trial will be one of the largest clinical studies of naturally derived psilocybin to date. Investigators will provide periodic interim safety and efficacy readouts, with full topline results available after dosing and follow-up evaluations are completed for all 200 participants.

The Current Focus on Psychedelics

Earlier this year, the US Food and Drug Administration (FDA) announced a series of regulatory actions aimed at accelerating development of psychedelic-based treatments for serious mental illness.² Following this announcement, the agency in April 2026 issued priority review vouchers for psilocybin in treatment-resistant depression and MDD and for methylone in posttraumatic stress disorder (PTSD), and cleared an investigational new drug application for noribogaine hydrochloride, an ibogaine derivative, permitting the first US-based phase 1 trial of the compound in alcohol use disorder. The agency also accepted, through a rolling submission, a new drug application for Compass Pathways' COMP360 psilocybin formulation in treatment-resistant depression, and said it would finalize guidance for sponsors developing serotonin-2A agonist therapies to address methodological challenges such as blinding integrity, psychotherapy standardization, patient monitoring, and endpoint selection.³

The actions followed a presidential executive order directing the US Department of Health and Human Services to accelerate treatment options amid the nation's mental health crisis. Optimi's trial falls under Health Canada's jurisdiction rather than the FDA's, but the announcement reflects a broader shift toward treating psilocybin and related compounds as candidates for rigorous, registration-directed clinical development rather than solely as investigational or special-access therapies.

Optimi has framed the phase 2 trial as an initial step toward potential drug registration, building on its existing Health Canada Drug Establishment Licence and its role supplying psilocybin through Health Canada's Special Access Program. The company said it plans to fund the trial with current cash on hand, with additional details on trial sites expected as the study moves toward initiation in the first half of 2027.

References

1. Optimi Health to initiate phase 2 clinical trial evaluating psilocybin-assisted therapy for major depressive disorder. News release. September 10, 2026. Accessed September 10, 2026. https://finance.yahoo.com/healthcare/articles/optimi-health-initiate-phase-2-124500744.html

2. FDA accelerates action on treatments for serious mental illness following executive order. News release. April 24, 2026. Accessed September 10, 2026. https://www.fda.gov/news-events/press-announcements/fda-accelerates-action-treatments-serious-mental-illness-following-executive-order

3. FDA fast-tracks psychedelic therapies for depression, PTSD, and alcohol use disorder. Psychiatric Times. April 24, 2026. https://www.psychiatrictimes.com/view/fda-fast-tracks-psychedelic-therapies-for-depression-ptsd-and-alcohol-use-disorder.