04Global accessJurisdiction map — Q1 2026
Direct to clinic, in the markets where access exists.
Optimi supplies finished-dose psilocybin and MDMA capsules through regulated medical-access pathways. Products reach patients via authorized prescribers under the frameworks listed below.
04.01JurisdictionsStatus — Q1 2026
Australia
TGA Authorized Prescriber Scheme
Active since 2024. Psilocybin for TRD and MDMA for PTSD.
Shipping
Canada
Special Access Program
Optimi supports clinical programs under Canada's SAP framework.
Supported
United States
FDA pathways, post-rescheduling
Infrastructure and quality systems ready for U.S. access as federal rescheduling develops.
Planned
European Union
National access schemes
Evaluating national-level authorized-access pathways.
Evaluating