A commercial-stage psychedelic drug manufacturer.
Optimi Health Corp. manufactures finished-dose psilocybin and MDMA capsules at a Health Canada Drug Establishment-licensed facility in British Columbia, and supplies them to authorized psychiatrists in Australia under the TGA Authorized Prescriber Scheme.
Natural Psilocybin Extract, MDMA 60 mg, MDMA 40 mg. Manufactured under Health Canada Drug Establishment Licence. Supplied to authorized prescribers under TGA Authorized Prescriber Scheme, Australia.
Product images are for illustrative purposes only and do not reflect final commercial packaging, labeling, or presentation.
Overview.
Optimi Health Corp. (CSE: OPTI · OTCQX: OPTHF) produces finished-dose psilocybin and MDMA capsules for regulated therapeutic use. The Company operates a Health Canada GMP-compliant facility and holds a Drug Establishment Licence authorizing commercial manufacture, packaging, testing, and international export of controlled drug products.
Active supply operations began under the Australian Authorized Prescriber Scheme in 2024. Product is dispensed to patients through authorized clinics for post-traumatic stress disorder and treatment-resistant depression.
The Company is structured to scale into additional jurisdictions as regulatory access develops, including the United States upon federal rescheduling.
In market.
- 01 · NaturalCapsule
Natural Psilocybin Extract
- API
- 4-PO-DMT
- Access
- Australia TGA APS
- Use
- Treatment-resistant depression
- 02 · SyntheticCapsule
MDMA 60 mg
- API
- MDMA HCl
- Access
- Australia TGA APS
- Use
- Post-traumatic stress disorder
- 03 · NaturalInitiativeComing soonIbogaineGMP supply under Optimi's Ibogaine Initiative — launched April 2026.
Ibogaine
- API
- Ibogaine alkaloid
- Access
- Coming soon
- Use
- OUD / PTSD / TBI
Product images are for illustrative purposes only and do not reflect final commercial packaging, labeling, or presentation.
| 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 |
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.
A beginner's guide to psychedelic pharmaceuticals.
The molecules, the manufacturing standards, and the access frameworks — written for readers who need to understand this market in depth without a biotech background.
- 01 · Psilocybin
Natural psilocybin, GMP-manufactured.
What the molecule is, how it's made, and why pharmaceutical-grade purity separates regulated-access supply from everything else.
Read → - 02 · MDMA
A 40-year-old molecule, a new therapeutic pathway.
Why MDMA-assisted therapy is distinct from recreational use, what the pivotal trials showed, and what commercial manufacture requires.
Read → - 03 · Ibogaine
A West African alkaloid, newly on the U.S. policy agenda.
The naturally occurring compound behind Optimi's Ibogaine Initiative — studied for opioid use disorder, PTSD, and TBI, and named in the April 2026 U.S. Executive Order on psychedelic drug products.
Read → - 04 · GMP manufacturing
What 'pharmaceutical-grade' actually means.
From research-grade to GMP-certified: why controlled-substance drug manufacture is a different category of work — and why commercial access programs require it.
Read → - 05 · Regulatory landscape
Where regulated access is emerging.
A country-by-country read of the access frameworks that make commercial psychedelic supply possible in 2026.
Read → - 06 · Current market
Where commercial-stage psychedelic companies stand today.
The difference between research-stage and commercial-stage, where revenue comes from, and how Optimi fits among the public comparables.
Read →
Built to pharmaceutical standards.
GMP facility
20,000-square-foot Health Canada-inspected facility with a Drug Establishment Licence authorizing commercial manufacture, packaging, testing, and export of controlled drug products.
Qualified Person release
Every batch signed off by a QP per Canadian pharmaceutical regulations. HPLC-MS identity and potency, USP-grade impurity panels, validated stability.
Chain-of-custody export
International narcotic export permits issued per shipment. Controlled-drug chain-of-custody from plant floor to authorized importer to prescribing clinic.
Where regulated supply is possible.
Leadership team.
Dane Stevens
Chief Executive Officer & Co-Founder
CEO since October 2024; co-founder since 2020. Nearly two decades in sourcing, manufacturing, and global distribution. Focused on producing GMP-certified MDMA and natural psilocybin for regulated treatment programs.
Jacob Safarik
Chief Financial Officer
Chartered Professional Accountant (CPA). 16+ years in accounting, project finance, business development, and quality assurance. Responsible for financial strategy, capital allocation, and cost management.
Bryan Safarik
Chief Operating Officer
Nearly two decades of senior management across regulated industries. Former Director of Marine Operations at Ocean Fisheries Ltd. Co-founded a federally licensed cannabis production company. Oversees production and GMP-certified manufacturing.
Dr. Preston Chase
Chief Science Officer
R&D chemist with 25+ years of experience. BSc from University of Victoria; PhD from University of Calgary. 30+ peer-reviewed publications; multiple awarded and pending patents across catalysis, synthesis, and analytical chemistry.
Press releases.
Optimi Health Files LIFE Offering Document in Connection with NASDAQ Listing
Optimi intends to complete a portion of its previously announced common share offering in Canada pursuant to the Listed Issuer Financing Exemption under National Instrument 45-106, alongside its US offering led by Joseph Gunnar & Co.
Optimi Health Launches Ibogaine Initiative as U.S. Executive Order Signals Pathway for Psychedelic Drug Products
The Company's Health Canada-licensed GMP psychedelic manufacturing platform ready to serve emerging demand for ibogaine, a naturally occurring alkaloid under investigation for opioid use disorder, PTSD, and traumatic brain injury
Optimi Health Reports Early Clinical Rollout of Natural Psilocybin Capsules for Treatment-Resistant Depression in Australia
First Patients of 2026 Treated Outside of Sponsor-Led Clinical Trials Under Australia's Regulated Framework
ir.optimi.net
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