Optimi Health Secures Ibogaine Supply, Begins Finished Drug Product Development at GMP Facility

With a U.S. Executive Order placing ibogaine on the accelerated FDA review track and federal funding beginning to flow toward psychedelic research programs, Optimi Health Corp. is moving to position its Health Canada-licensed British Columbia facility as a primary GMP-grade source for ibogaine finished drug products. Development work is scheduled to commence this summer.

Optimi has secured naturally derived ibogaine from two sources, in both hydrochloride (HCl) and freebase form. The in-house development program will establish SOPs covering finished drug encapsulation, dosage strengths, bottling, labeling, and packaging, alongside validation of manufacturing and analytical testing methods. Two dosage sizes are planned: 50 mg and 100 mg in encapsulated format.

The regulatory asymmetry between Canada and the United States is central to Optimi's manufacturing rationale. In Canada, ibogaine is not scheduled under the Controlled Drugs and Substances Act; it is regulated under the Food and Drugs Act and listed on Health Canada's Prescription Drug List. In the United States, ibogaine remains a Schedule I controlled substance. That distinction, combined with Optimi's existing GMP infrastructure and current Health Canada licensing, allows compliant manufacture and cross-border supply to support clinical trials and regulated access programs without the scheduling constraints that would apply to a U.S.-based manufacturer.

The April 18, 2026 Executive Order directed federal funding to match state investments in psychedelic research, intensifying institutional demand for a reliable, characterized ibogaine supply. A $50 million Texas state program was cited by CEO Dane Stevens as representative of the public funding now behind ibogaine research. Optimi already manufactures psilocybin and MDMA at the same British Columbia facility, giving the ibogaine program an established GMP baseline and an existing analytical infrastructure to draw on.

The clinical rationale for ibogaine development has strengthened with a 2024 Stanford-led study published in Nature Medicine, which reported reductions in PTSD, depression, anxiety, and functional disability in U.S. Special Operations veterans following a single ibogaine treatment protocol. Ibogaine is under investigation across opioid use disorder, PTSD, and traumatic brain injury indications.

Optimi has indicated it will provide a program update upon completion of the finished drug development work, with inquiries for special access and clinical trial supply directed to its commercial team.

The pace of method validation and SOP finalization this summer will determine how quickly Optimi can qualify ibogaine product for clinical trial supply chains ahead of anticipated FDA review milestones.

Source: Optimi Health Corp. via GlobeNewswire/IBN, June 8, 2026.