Optimi Health Launches Ibogaine Initiative, Expanding its Health Canada-Licensed GMP Platform for Psychedelic Manufacturing
Trump's Executive Order Fast-Tracks Psychedelic Drug Research and Patient Access
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 Corp. (CSE: OPTI,OTC:OPTHF) (OTCQX: OPTHF) (FSE: 8BN) (the "Company" or "Optimi"), a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products, today launched its Ibogaine Initiative, a program to extend the Company's Health Canada-licensed GMP platform to include the manufacture and supply of ibogaine. The initiative comes as the United States has, for the first time, taken initial steps toward a federal policy framework intended to accelerate research and patient access to psychedelic drug products.
Ibogaine is a naturally occurring alkaloid derived from the root bark of the Tabernanthe iboga shrub, native to Central and West Africa. It has been studied for its potential to interrupt opioid withdrawal and craving, and for its effects on substance-use disorders, post-traumatic stress disorder (PTSD), and traumatic brain injury (TBI). A 2024 Stanford-led study of U.S. Special Operations veterans, published in Nature Medicine, reported reductions in PTSD, depression, anxiety, and functional disability in a cohort following a single ibogaine treatment protocol.
Optimi is commercial-stage in Australia, where authorized physicians are actively prescribing the Company's MDMA for PTSD and its naturally derived psilocybin for treatment-resistant depression (TRD). In parallel, the Company supplies pharmaceutical-grade MDMA and psilocybin to clinical trials and special access programs globally.
As part of its U.S. market readiness strategy, Optimi obtained an FDA Establishment Identifier (FEI) number in 2025, supporting its ability to engage with U.S. regulatory and commercial pathways as they evolve.
On April 18, 2026, U.S. President Donald Trump signed an Executive Order directing federal agencies to accelerate research, regulatory review, and patient access pathways for psychedelic drug products, including ibogaine. At the signing, FDA Commissioner Marty Makary confirmed Investigational New Drug (IND) clearance for ibogaine, enabling sponsors to advance U.S. clinical trials. The Order directs the Advanced Research Projects Agency for Health (ARPA-H) to match qualifying state-level investments in psychedelic research, beginning with a $50 million federal allocation, which may be paired with Texas's previously authorized $50 million ibogaine research commitment. The Order also extends federal Right to Try eligibility to psychedelic drug products and contemplates priority review mechanisms, such as the Commissioner's National Priority Voucher, to potentially shorten FDA review timelines.
Management Commentary
Dane Stevens, Chief Executive Officer and Co-Founder of Optimi Health, said:
"Optimi already manufactures and supplies GMP-grade psychedelic drug products to patients under regulated frameworks, and today in Australia, doctors are prescribing our MDMA for PTSD and psilocybin for treatment-resistant depression.
Taken together, these actions move ibogaine from what has historically been a fragmented, primarily offshore ecosystem toward a defined U.S. regulatory and funding pathway. The ibogaine market took shape in a meaningful way over the weekend following a U.S. Executive Order, and it will require high-quality, regulated supply. With a fully GMP, Health Canada-licensed manufacturing infrastructure in place, Optimi is well positioned to support this next phase of market development,"
About Optimi Health Corp.
Optimi Health Corp. (CSE: OPTI,OTC:OPTHF) (OTCQX: OPTHF) (FSE: 8BN) is a leading producer of prescribed psychedelic treatments for mental health therapies. As a Health Canada-licensed, GMP compliant pharmaceutical manufacturer producing validated MDMA and botanical psilocybin products from two 10,000-square-foot facilities in British Columbia, Optimi supplies active pharmaceutical ingredients and finished dosage forms to regulated channels, with products currently in market for prescription use in Australia via the Authorized Prescriber Scheme and accessible in Canada through the Special Access Program. For more information, please visit www.optimihealth.ca.
