Optimi Health Corp. has completed production of a batch of naturally derived 5mg psilocybin capsules intended for a clinical trial evaluating psilocybin-assisted therapy for major depressive disorder.
The batch was manufactured at a cGMP facility in Princeton, British Columbia, under a Health Canada Drug Establishment Licence. The open-label, multisite study will enroll up to 200 participants, each receiving a single supervised dose. Patient dosing is expected to conclude by the end of 2027.
Optimi has supplied the psilocybin product commercially to licensed clinics in Australia since 2025. Under the Therapeutic Goods Administration's Authorised Prescriber Scheme, the drug can be prescribed to patients with treatment-resistant depression. Public and private payers covering reimbursement include the Department of Veterans' Affairs, the National Disability Insurance Scheme, WorkCover, and Medibank.
"Since 2025, Optimi has supplied this psilocybin product commercially to licensed clinics in Australia, where it is prescribed and reimbursed for treatment-resistant depression," said CEO and co-founder Dane Stevens.
The company stated it is not aware of any reported serious adverse events since commercial supply began in 2025. More than 750 clinicians have completed Mind Medicine Australia's Certificate in Psychedelic-Assisted Therapies, providing a growing practitioner base for the trial and commercial program.
Optimi Health trades on the NASDAQ under OPTH, the CSE under OPTI, and the FSE under 8BN.
