HOW IS OPTIMI POSITIONED TO WIN THE ROLLOUT OF MDMA & PSILOCYBIN?
5% of the world is depressed and Optimi is ready to deliver cost effective, GMP MDMA & Psilocybin Capsules under their Drug Establishment Licence to regulated markets around the world upon rescheduling.
Why Invest in Optimi Now?
Optimi Health is a licensed GMP manufacturer with prescribable MDMA and psilocybin already in market. With strong regulatory backing and scalable production, we are positioned for growth in the expanding psychedelic sector.
Key Milestones Explained
Optimi Health has achieved significant milestones, from securing Health Canada’s Drug Establishment Licence to successfully exporting GMP-certified MDMA and psilocybin for prescription use. These milestones demonstrate our commitment to advancing psychedelic therapies and positioning Optimi as a leader in the industry.
Optimi’s MDMA & Psilocybin Now Prescribable
Australia’s TGA has approved Optimi’s MDMA and psilocybin for PTSD and treatment-resistant depression, making them available by prescription.
Real World Evidence Collection & Patient Outcomes
In partnership with Mind Medicine Australia, Optimi will access patient data on MDMA and psilocybin for PTSD and TRD, supporting global NDA submissions with real-world evidence.
Drug Establishment Licence & GMP Manufacturing
Optimi Health, a Health Canada GMP-compliant manufacturer, provides MDMA and psilocybin for prescription where allowed, backed by its Drug Establishment and Controlled Substances Licences.
Phase II Clinical Trial Partnership for MDD
Optimi’s 5mg Psilocybin Capsule enters a Phase 2 trial for Major Depressive Disorder, paving the way for Phase 3 and potential breakthrough status.
Pathway to US Exchange Listing in 2026
As a Health Canada-licensed GMP manufacturer, Optimi’s MDMA and psilocybin capsules are available by prescription in Australia. While most companies remain in clinical trials awaiting FDA approval, Optimi is de-risked and in-market.
