Optimi Health finishes psilocybin batch for Canadian MDD trial and Australian TRD supply

Optimi Health Corp. announced on September 23, 2026 that it completed and released a production batch of psilocybin capsules at its facility in Princeton, British Columbia. The batch consists of 5mg naturally derived psilocybin capsules, manufactured under the company's Health Canada Drug Establishment Licence at its cGMP facility.¹

The same batch is intended to supply a newly announced Phase 2 clinical trial of psilocybin-assisted therapy for major depressive disorder, along with commercial customers in Australia.¹ The Health Canada-authorized study is described as a multisite, open-label trial enrolling up to 200 participants, each receiving one supervised dose.¹ The company said dosing is expected to finish by the end of 2027, with trial data meant to support an evidence base for eventual registration in Canada and other jurisdictions.¹

On the commercial side, the batch will also go to Optimi's Australian clinic network, where the 5mg psilocybin capsules are prescribed for treatment-resistant depression under the Therapeutic Goods Administration's Authorised Prescriber Scheme, with reimbursement available through several public and private payers.¹ The company said more than 750 clinicians have completed Mind Medicine Australia's psychedelic-assisted therapy certificate program, and that it is not aware of any reported serious adverse events since commercial supply began in 2025.¹

CEO Dane Stevens said the trial and commercial products share the same formulation and batch, and that the company's existing Chemistry, Manufacturing and Controls file already supports both uses. Optimi noted that psilocybin's safety and efficacy for MDD remain under investigation, and that none of its psilocybin products have received Health Canada market authorization.¹