Optimi Health Launches Ibogaine Initiative as U.S. Executive Order Signals Pathway for Psychedelic Drug Products
Newsfile
April 20, 2026 10:00AM GMT
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
Vancouver, British Columbia--(Newsfile Corp. - April 20, 2026) - Optimi Health Corp. (CSE: OPTI) (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," concluded Stevens.
Organizations, sponsors, and treatment providers interested in exploring ibogaine supply, research collaboration, or clinical program support are encouraged to contact Optimi at sales@optimihealth.ca.
For more information, please contact:
Dane Stevens, CEO
Optimi Health Corp.
(778) 761-4551
investors@optimihealth.ca
www.optimihealth.ca
Investor Relations Contact:
Lucas A. Zimmerman
Managing Director
MZ Group - MZ North America
(262) 357-2918
OPTHF@mzgroup.us
www.mzgroup.us

About Optimi Health Corp.
Optimi Health Corp. (CSE: OPTI) (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.
Forward-Looking Statements
This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, "forward-looking statements"), including with respect to the role of psychedelic medicines in insured mental health care. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties, and contingencies, certain of which are unknown. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions, or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward-looking statements. These statements may involve estimates, assumptions, and uncertainties that could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct, and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.
Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond the Company's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Such risk factors include but are not limited to those factors which are discussed in the Company's continuous disclosure filings available under its SEDAR+ profile at www.sedarplus.ca. Except as expressly required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for the Company to predict all of them or assess the impact of each factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
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