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, Natural Microdose 1 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. (NASDAQ: OPTH · CSE: OPTI) 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 · NaturalCapsule
Natural Microdose
- API
- 4-PO-DMT · 1 mg
- Access
- Australia TGA APS
- Use
- Microdosing protocols
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 |
Natural Microdose 4-PO-DMT · 1 mg | Shipping Launching 2026 | Supplying Special Access Program | Planned Awaiting federal rescheduling | 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.
Robert Martin
Chief Strategy Officer
Seattle-based growth investor for over 20 years, investing at the earliest stages of companies based in the Northwestern US and Canada focused on the betterment of the human condition. Extensive board and advisory board experience, including developing strategic partnerships, making key hires, raising capital, and guiding companies through mergers and acquisitions. As a serial entrepreneur and operator, he and his partner sold two businesses to private equity. He started his career in investment banking upon graduation from George Washington University with an MBA in Finance and Investments.
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.
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 Completes Psilocybin Export to Australia for Patients With Treatment-Resistant Depression
Optimi’s 5mg psilocybin capsules are prescribed in Australia for treatment-resistant depression. The export marks Optimi’s third commercial shipment since launching the 5mg psilocybin capsules in September 2025.
Optimi Health Launches Standardized Microdose Psilocybin Products for Clinical Research
Two naturally derived finished drug products, at 1mg and 2mg, give research organizations the consistent, validated doses required for controlled studies
Optimi Health Completes First Export of Psilocybin to the United Kingdom for Phase 2 Clinical Trial
The shipment of naturally derived psilocybin, comprising both biomass and 5mg capsules, supports a planned Phase 2 clinical trial in the United Kingdom and...
ir.optimi.net
Filings, stock information, governance, earnings, and press-release subscriptions — the full investor-relations site is separate from this marketing site for clarity and SEDAR+/SEC EDGAR linkage.
Get press releases and SEC/SEDAR+ filings by email as they are issued.
Double opt-in via ir.optimi.net · unsubscribe anytime