Optimi
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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.

This page covers Optimi's active supply pathways. For the broader global regulatory landscape, see knowledge · regulatory →

04.01Jurisdiction map8 tracked
Active access framework
Emerging / pilot
Monitoring
04.02Optimi pathwaysStatus — 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