Shares of Optimi Health Corp. (NASDAQ:OPTH) climbed 16.6% on Monday after the Vancouver-based pharmaceutical manufacturer announced it had secured naturally derived ibogaine supply intended for pharmaceutical development.
The company said the ibogaine was obtained from two separate sources and is available in both hydrochloride and freebase formulations. Optimi plans to begin development work on the finished drug product this summer at its Good Manufacturing Practice (GMP) facility in British Columbia, Canada.
Optimi outlined plans to produce two encapsulated dosage sizes - 50 mg and 100 mg. The development program will include the establishment of standard operating procedures for finished drug encapsulation, defined dosage strengths, bottling, labeling, and packaging.
The announcement comes after an April 18 U.S. Executive Order that identified ibogaine compounds among psychedelic therapies to be prioritized for accelerated Food and Drug Administration review and for expanded patient access. The executive action also directed federal funding to match state investments in psychedelic research.
"We are seeing a growing number of research institutions interested in ibogaine, and there is real public funding behind it now, including the $50 million program in Texas," said Dane Stevens, Chief Executive Officer and Co-Founder of Optimi.
The regulatory environment for ibogaine differs between Canada and the United States. In Canada, ibogaine is not classified as a controlled substance under the Controlled Drugs and Substances Act, but it is regulated under the Food and Drugs Act and appears on Health Canada’s Prescription Drug List. In the United States, ibogaine remains listed as a Schedule I substance.
Ibogaine is described as a naturally occurring alkaloid that is extracted from the root bark of the Tabernanthe iboga shrub. The compound is currently under clinical investigation for potential therapeutic uses including treatment of post-traumatic stress disorder (PTSD), opioid use disorder, and traumatic brain injury.
The company’s announcement references clinical interest and research activity. A 2024 Stanford-led study published in Nature Medicine reported reductions in PTSD, depression, anxiety, and functional disability in U.S. Special Operations veterans following a single ibogaine treatment protocol, according to the information disclosed.
Sectors affected: pharmaceutical manufacturing, clinical research, psychedelics-focused biotech, and capital markets for emerging therapeutics.