Optimi Health has completed production of a new batch of 5mg naturally derived psilocybin capsules, with the same batch set to supply both a new Canadian Phase 2 clinical trial and licensed Australian clinics treating patients with treatment-resistant depression.
Optimi Health has completed and quality-released a new batch of 5mg naturally derived psilocybin capsules at its cGMP facility in Princeton, British Columbia.
The batch was manufactured end-to-end under Optimi’s Health Canada Drug Establishment Licence and will be used for two different purposes: a Health Canada-authorised Phase 2 clinical trial in major depressive disorder (MDD) and commercial supply to licensed clinics in Australia.
The Canadian trial is expected to begin in the first half of 2027 and will enrol up to 200 participants across multiple sites. Participants will receive a single supervised dose of Optimi’s naturally derived psilocybin alongside therapy, with dosing expected to be completed by the end of 2027.
For Optimi, the Australian connection is particularly notable because the product being supplied commercially is the same 5mg formulation being taken into the company’s clinical development programme.
Optimi says the new batch will supply Australian clinics where its psilocybin capsules are prescribed for treatment-resistant depression under the Therapeutic Goods Administration’s Authorised Prescriber Scheme. The company began commercially supplying its 5mg capsules in Australia in September 2025 and completed its third commercial shipment in June 2026, when a further 1,000 capsules were exported to the country.
Australia’s regulatory framework allows specialist psychiatrists who have received both Human Research Ethics Committee approval and TGA Authorised Prescriber approval to access unapproved psilocybin medicines for patients with treatment-resistant depression. Psilocybin remains an unapproved therapeutic good in Australia and is not included in the Australian Register of Therapeutic Goods.
The framework is also considerably more restrictive than ordinary prescription medicine access. Authorised psychiatrists must operate under an approved clinical treatment protocol, while patients must take psilocybin under supervision in an appropriate clinical setting rather than receiving the medicine to take home.
That makes the Australian supply side an unusual part of Optimi’s development strategy. The company is already supplying a finished psilocybin drug product to patients through the country’s regulated access pathway while simultaneously generating clinical data on the same formulation in Canada.
The Phase 2 study is designed to investigate the safety and efficacy of a single supervised dose of natural psilocybin in people with MDD. Its primary efficacy measure will be the change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline, with the resulting data intended to contribute to potential registration efforts in Canada and other jurisdictions.
Optimi’s approach also gives it control over the manufacturing side of the programme. The company says the trial product and Australian commercial product are manufactured and released through its own facility, with the same formulation being used across the two settings. It also says it retains ownership of the clinical trial data and the Chemistry, Manufacturing and Controls documentation supporting its drug products.
The company has been building towards this position for several years. In 2024, Optimi and ATMA received Health Canada approval to proceed with a Phase 2 trial using Optimi’s GMP natural psilocybin capsules in 200 participants, building on the product’s emerging use in Australia.
The latest production milestone therefore sits at the intersection of two very different stages of psychedelic medicine development. In Australia, psilocybin can already be accessed by a narrowly defined patient population through the Authorised Prescriber system, while in Canada Optimi is still working to generate the clinical evidence that could eventually support formal registration.
For the wider industry, it is another example of how psychedelic drug development is beginning to involve more than clinical trials alone. Manufacturing capacity, international supply arrangements, controlled patient access and registration studies are increasingly being developed alongside one another.
The Canadian Phase 2 trial will ultimately need to establish whether the treatment is safe and effective in MDD. For now, the significance of the new production batch is more straightforward: Optimi has a single GMP-manufactured product moving through both a regulated clinical research programme and an established, tightly controlled patient-access pathway in Australia.
