Optimi Health Corp., a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products, has announced the successful completion of its first export of naturally derived psilocybin to the United Kingdom. This shipment is intended to support a planned Phase 2 clinical trial and includes both psilocybin biomass and finished 5mg capsules.
Regulatory Approvals and Product Details
The export was conducted under an export authorization from Health Canada and an import authorization from the UK Home Office. The psilocybin capsules use the same formulation currently prescribed to patients in Australia for treatment-resistant depression (TRD). Optimi plans to announce the trial partner and specific indication at a later date.
Manufacturing and Supply Chain
The product was manufactured at Optimi's Good Manufacturing Practice (GMP) facility in Princeton, British Columbia, Canada. The company cultivated the biomass and produced the finished capsules in-house, extracting the active pharmaceutical ingredient (API) using proprietary methods under its Health Canada Drug Establishment Licence (DEL). This vertical integration allows Optimi to supply both biomass and finished drug products from a single licensed facility.
Dane Stevens, CEO and Co-Founder of Optimi, stated: "This is our first shipment into the United Kingdom, and it is the same psilocybin we already supply to patients in Australia. We can serve a commercial market and a clinical trial from the same GMP facility, on our own licence. That is a rare position, and one we have spent years building."
Strategic Implications
The export follows Optimi's recent completion of a GMP production run of its 5mg psilocybin drug product, a portion of which was allocated for clinical research in Europe. The company supplies finished psilocybin and MDMA drug products to regulated markets internationally, supporting both patient access and clinical research.
Optimi Health Corp. (NASDAQ: OPTH, CSE: OPTI, FSE: 8BN0) is a commercial-stage pharmaceutical company focused on manufacturing and distributing GMP-grade psychedelic drug products for mental health therapies. As a Health Canada-licensed manufacturer, Optimi produces validated MDMA and botanical psilocybin drug products at its GMP-compliant facilities in British Columbia, Canada. The company supplies both active pharmaceutical ingredients and finished dosage forms to regulated clinical and therapeutic programs internationally, with products currently prescribed to patients in Australia under the Authorized Prescriber Scheme and accessible in Canada through the Special Access Program.
