Optimi Health has produced and quality‑released a single cGMP batch of 5mg psilocybin capsules to support a Health Canada‑authorised Phase II trial for major depressive disorder and to supply licensed clinics in Australia. The multi‑site, open‑label study will enroll up to 200 participants, each receiving one supervised dose, with dosing due to finish by the end of 2027. Optimi already supplies the same formulation commercially in Australia under the TGA Authorised Prescriber Scheme and says some treatment costs may be reimbursed by public and private payers.
Optimi Health Releases 5mg Psilocybin Batch for Health Canada Phase II MDD Trial and Australian Clinics
The psilocybin capsules will be used in a multi-site
Optimi Health has completed production and quality release of a single cGMP batch of 5mg psilocybin capsules that will supply a Health Canada‑authorised Phase II clinical trial for major depressive disorder (MDD) and licensed clinics in Australia.
The naturally derived capsules were manufactured at Optimi’s current good manufacturing practice (cGMP) facility in Princeton, British Columbia, under its Health Canada Drug Establishment Licence. This one batch will support a multi‑site, open‑label study enrolling up to 200 participants; each participant is expected to receive a single supervised dose. Patient dosing is scheduled to conclude by the end of 2027.
Study Goals and Regulatory Context
The Phase II study aims to collect safety and preliminary efficacy data for psilocybin‑assisted therapy in MDD, contributing evidence that could support future regulatory submissions in Canada and other jurisdictions. In Australia, Optimi’s 5mg capsules have been supplied commercially since 2025 under the Therapeutic Goods Administration’s Authorised Prescriber Scheme.
Optimi also states that treatment costs in Australia may be reimbursed by a range of public and private payers, including the US Department of Veterans’ Affairs, Medibank, the National Disability Insurance Scheme (NDIS) and WorkCover.
Dane Stevens, Optimi CEO and Co‑Founder, 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."
Optimi notes that the safety and efficacy of psilocybin‑assisted therapy for MDD remain under investigation, and to date none of its psilocybin drug products has received market authorisation from Health Canada.
Original reporting by Clinical Trials Arena, a GlobalData brand.
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