Investor relations.
Optimi Health Corp. is a commercial-stage psychedelic drug manufacturer, GMP-licensed by Health Canada, producing MDMA capsules and natural psilocybin extract for regulated treatment programs. This page provides the official stock, filings, and disclosure channels for investors.
| Product | Australia TGA APS | Canada Health Canada SAP | United States FDA pathway | European Union National schemes |
|---|---|---|---|---|
Natural Psilocybin Extract 4-PO-DMT · Capsule | Shipping Since 2024; routine exports | Supplying Special Access Program | Planned Awaiting federal rescheduling | Evaluating Monitoring national access |
MDMA 60 mg MDMA HCl · Capsule | Shipping Active under APS | Supplying SAP + clinical trials | Planned Awaiting federal rescheduling | Evaluating Monitoring national access |
MDMA 40 mg MDMA HCl · Capsule | Shipping Active under APS | Supplying SAP + clinical trials | Planned Awaiting federal rescheduling | Evaluating Monitoring national access |
Ibogaine Initiative · 2026 | Evaluating Assessing APS framework | Planned GMP scale-up 2026 | Planned Post-EO / IND clearance (Apr 2026) | Evaluating Monitoring national access |
Status reflects current Company operations. Optimi supplies product into regulated access pathways rather than conducting clinical trials as a drug developer. Shipping = routine commercial exports; Supplying = active supply into research programs or special-access pathways; Planned = infrastructure in place, awaiting regulatory access; Evaluating = tracking the jurisdiction.
Optimi Health Completes Commercial Psilocybin Production to Address Treatment-Resistant Depression in Australia
Optimi’s 5mg psilocybin capsules are prescribed commercially for treatment-resistant depression in Australia, with additional product from the run earmarked for planned clinical trials in the United States and Europe
Optimi Health Welcomes Expanded Psychedelic-Assisted Therapy Access Under Updated Authorized Prescriber Framework in Australia
Updated TGA recommendations broaden therapist eligibility, accept a wider range of treatment settings, and reinforce Australia's position as the world's leading commercial market for prescribed psilocybin and MDMA
Optimi Health Advances Highest-Purity Natural Psilocybin Extract to Date
The 6% naturally derived extract is set to be encapsulated for use in patients suffering from treatment-resistant depression under Australia's Authorised Prescriber Scheme, where no serious adverse events have been reported as of December 2025
- Form 6-KForeign private issuer report
- Form 6-KForeign private issuer report
- Form 6-KForeign private issuer report