A West African alkaloid, newly on the U.S. policy agenda.
The naturally occurring compound behind Optimi's Ibogaine Initiative — studied for opioid use disorder, PTSD, and TBI, and named in the April 2026 U.S. Executive Order on psychedelic drug products.
Ibogaine is a naturally occurring alkaloid derived from the root bark of Tabernanthe iboga, a shrub native to Central and West Africa. It has a long ceremonial history in the Bwiti tradition of Gabon and has been studied outside that context for its pharmacology since the mid-20th century.
The molecule is distinct from classical psychedelics like psilocybin and MDMA — it binds to multiple receptor systems, including NMDA, κ-opioid, and sigma-2 — and is studied at sub-psychedelic as well as psychedelic doses.
Opioid use disorder
Studied for its ability to interrupt opioid withdrawal and reduce craving in the days after a single dosing. Human reports date to the 1960s; formal pharmacology followed in the 1990s.
PTSD & traumatic brain injury
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.
Substance-use disorders broadly
Observational and open-label work on alcohol, cocaine, and methamphetamine use disorder, though rigorously controlled evidence remains limited.
On April 18, 2026, the U.S. President 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, the FDA Commissioner 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.
Optimi launched its Ibogaine Initiative on April 20, 2026, to extend the Company's Health Canada-licensed GMP manufacturing platform to include the manufacture and supply of ibogaine.
As part of its U.S. market readiness strategy, Optimi obtained an FDA Establishment Identifier (FEI) numberin 2025, supporting the Company's ability to engage with U.S. regulatory and commercial pathways as they evolve. With a fully GMP, Health Canada-licensed manufacturing infrastructure already in place, Optimi is positioned to support emerging regulated demand for ibogaine.
We're preparing a full pharmacology + QT-prolongation safety discussion to sit alongside the psilocybin and MDMA primers. In the meantime, the Nature Medicine Stanford-led study is a strong starting point.