Canada — Health Canada & Optimi Health

Canada — Health Canada: Canada — Health Canada's regulation of ibogaine under the Food and Drugs Act and its listing on the Prescription Drug List provides a favorable regulatory environment for Optimi Health's operations.

Optimi Health: Optimi Health has secured ibogaine supply and is commencing development of finished drug products, positioning itself as a key supplier in the emerging psychedelic therapy market.

Canada — Health Canada: Canada — Health Canada issued the Drug Establishment Licence (DEL) to Optimi Health, authorizing the company's manufacturing, packaging, labeling, testing, storage, and distribution of controlled drug products.

Optimi Health: Optimi Health completed its first export of psilocybin to the United Kingdom for a Phase 2 clinical trial, expanding its international market reach and solidifying its position as a vertically integrated GMP supplier of psychedelic drug products. It also completed a GMP production run of 5mg psilocybin capsules, with some earmarked for clinical research in the United States and Europe.

Optimi Health: Optimi Health completed the first 2026 production and export of MDMA and psilocybin capsules to Australia, expanding its market access for psychedelic treatments for PTSD and TRD.