Optimi supplies psilocybin for depression in Australia

Executive Summary

• Optimi Health Corp. reports the early clinical rollout of its naturally derived five-milligram psilocybin capsules for the treatment of treatment-resistant depression (TRD) in Australia.
• Treatments have been administered under Australia's authorized prescriber scheme, marking the first psilocybin shipment of 2026 and representing early-stage clinical adoption within the regulated access pathway.
• The company is supplying both psilocybin for TRD and MDMA for posttraumatic stress disorder (PTSD) into Australia's nationally regulated medical framework, with production occurring at its accredited Canadian facilities.

Key Details

• Product: Naturally derived five-milligram psilocybin capsules.
• Indication: Treatment-resistant depression (TRD).
• Regulatory Framework: Australia's nationally regulated access framework via the authorized prescriber scheme.
• Supply Chain: Product dispensed through Optimi's licensed Australian pharmacy partner pursuant to approved import permits prior to clinical administration.
• Production: Both psilocybin and MDMA products are produced at Optimi's accredited facility in Canada, complying with Therapeutic Goods Administration (TGA) quality guidelines, including TGO 112 and TGO 113.
• Historical Context: This milestone occurs approximately six months following Optimi's initial commercial launch of psilocybin supply into Australia. Prior to this, the company completed multiple MDMA shipments for supply under the same scheme.
• Data Collection: Treatment data and patient-reported outcomes are being captured through Australia's national registry in partnership with the Australian National University.
• Access: Psilocybin-assisted therapy is prescribed through authorized programs supported by Mind Medicine Australia.

Notable Quotes

• "We are seeing the authorized prescriber pathway function as intended -- enabling regulated access for eligible patients under appropriate clinical oversight," said Ilan Hayman of Mind Medicine Australia. "The early administration of psilocybin-assisted therapy under this framework reflects careful implementation by clinicians and the continued maturation of Australia's regulated access model."