Optimi Health Reports Early Clinical Rollout of Natural Psilocybin Capsules for Treatment-Resistant Depression in Australia

Executive Summary

• Optimi Health reported the first administration of its 5 mg naturally derived psilocybin capsules to patients with treatment‑resistant depression (TRD) under Australia’s Authorised Prescriber Scheme.
• The rollout follows the company’s initial commercial launch of psilocybin in Australia six months earlier and adds to existing MDMA shipments for PTSD treatment.
• Treatments were dispensed through a licensed Australian pharmacy partner using approved import permits, with outcome data being captured via a national registry.

Key Details

• Patients diagnosed with TRD received 5 mg psilocybin capsules in authorized clinics across Australia under the Authorised Prescriber Scheme.
• This marks the early-stage clinical adoption of Optimi’s finished drug product within Australia’s nationally regulated access framework.
• The administration follows Optimi’s first psilocybin shipment of 2026 and builds on prior MDMA shipments for PTSD treatment in the same scheme.
• Both psilocybin (for TRD) and MDMA (for PTSD) are manufactured at Optimi’s Health Canada‑licensed GMP facilities in British Columbia and meet Therapeutic Goods Administration (TGA) Quality Guidelines (including TGO 112 and TGO 113).
• Product was dispensed through Optimi’s licensed Australian pharmacy partner pursuant to approved import permits before clinical administration.
• Treatment data and patient‑reported outcomes are being captured through Australia’s national registry in partnership with the Australian National University.
• Quote: “We are seeing the Authorised Prescriber pathway function as intended — enabling regulated access for eligible patients under appropriate clinical oversight,” said Ilan Hayman of Mind Medicine Australia.

Notable Quotes

• Ilan Hayman, 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.”