Optimi Health has completed the production and quality release of a batch of 5mg psilocybin capsules for a Health Canada-authorised Phase II major depressive disorder (MDD) trial and commercial supply to Australia.
The naturally derived capsules were manufactured at the company’s current good manufacturing practice (cGMP) facility in Princeton, British Columbia, under its Health Canada Drug Establishment Licence.
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The batch will be used in a multi-site, open-label study of up to 200 participants, as well as by Australian licensed clinics treating patients with treatment-resistant depression (TRD).
Each trial participant is expected to receive a single supervised dose. Patient dosing is scheduled to conclude by 2027-end.
The study is intended to generate safety and efficacy data for psilocybin-assisted therapy and contribute to the evidence required for possible registration in Canada and other jurisdictions.
In Australia, Optimi’s 5mg capsules are prescribed for TRD under the Therapeutic Goods Administration’s Authorised Prescriber Scheme.
The company said treatment costs can be reimbursed by public and private payers, including the US Department of Veterans’ Affairs, Medibank, the National Disability Insurance Scheme and WorkCover.
Optimi CEO and co-founder Dane Stevens said: “Since 2025, Optimi has supplied this psilocybin product commercially to licensed clinics in Australia, where it is prescribed and reimbursed for treatment-resistant depression.
“We are excited to be collecting our own clinical data on the same product in our Health Canada-approved Phase II clinical trial for major depressive disorder. One drug, two indications with significant unmet need, one batch serving both.
“Because we manufacture, encapsulate and release-test within our own licensed facility, the trial product and the commercial product are the same formulation from the same batch, and the Chemistry, Manufacturing and Controls file that supports registration is already ours.”
The safety and efficacy of psilocybin-assisted therapy for MDD remain under investigation. None of Optimi’s psilocybin drug products has received market authorisation from Health Canada.
