Optimi Health treats first 2026 patients in Australia

Executive Summary

• Optimi Health reports that the first MDMA-assisted treatments of 2026 are underway across an expanded network of authorized clinics in Australia under the Authorised Prescriber Scheme.
• The company continues to supply finished MDMA drug product directly to these clinics, maintaining manufacturing oversight and supporting patient treatment programs.
• Recent data indicates no serious adverse events (SAEs) were recorded among patients receiving MDMA-assisted therapy under the Australian scheme as of September 16, 2025.

Key Details

• Operational Status: First patients of 2026 have been treated with Optimi Health’s MDMA capsules at authorized clinics across Australia.
• Supply Chain: Optimi supplies finished MDMA drug product directly to authorized clinics under Australia's regulated prescribing framework.
• Safety Data: Aggregated information from a freedom of information request to the Therapeutic Goods Administration (TGA) shows zero serious adverse events (SAEs) for patients under the scheme as of Sept. 16, 2025.
• Market Context: The Australian Department of Veterans' Affairs (DVA) announced a $740-million veterans rehabilitation plan including support for psychedelic-assisted therapy for eligible veterans with PTSD.
• Data Collection: Patient-reported outcomes (PROs) are being collected by the Australian National University (ANU) as part of an expanding real-world evidence (RWE) program for MDMA-assisted therapy for PTSD.
• Regulatory License: Optimi holds a Health Canada drug establishment license authorizing the manufacture of 60-milligram and 40-milligram MDMA capsules for regulated therapeutic use, including PTSD treatment where permitted.
• Market Size: Approximately 5-6% of Australians (1.3-1.5 million people) experience PTSD annually, with higher prevalence among veterans and first responders.
• Contact for Access: Clinicians and programs may seek information through Mind Medicine Australia ([email protected]).

Notable Quotes

• "Entering 2026 with active treatments under way across a growing clinic network is an important step in the continued development of regulated MDMA-assisted therapy," said Dane Stevens, chief executive officer and co-founder of Optimi Health. "Our direct-to-clinic supply model allows us to maintain manufacturing oversight, ensure our product is cost-effective and support authorized prescribers within Australia's established regulatory framework. We believe this structure provides a scalable pathway for responsible commercial expansion."