FDA Opens the Door to Ibogaine: RFI on Early-Phase Trial Design Under Trump's Psychedelics Executive Order
October 5, 2026. The FDA announced a request for information (RFI) "describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products" — a formal step toward building the evidence base for a Schedule I hallucinogen that has never been approved as a medicine. The RFI seeks "comments, data, and information on specific protocol elements relevant to ibogaine drug development, including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules and safety oversight." Comments run 45 days from Federal Register publication — closing Friday, November 20, 2026 — under Docket No. FDA-2026-N-10429.
The framing is striking coming from a Schedule I substance with known cardiac risks. CDER Director Michael Davis, M.D., Ph.D.: "Patients facing serious conditions that have not responded to existing treatments deserve rigorous scientific investigation of promising new approaches... With ibogaine, there are important scientific questions as well as serious safety concerns. We are seeking high-quality data and input that can help inform clinical research while putting patient safety first."
The RFI asks for input in four areas: general study design (appropriate patient populations); dose selection and escalation — including "a starting dose justified by available data and not exceeding 10 mg/kg"; safety — "monitoring for cardiac and neurologic adverse events" (ibogaine's QT-prolongation/cardiac risk is the central hazard); and ethics and oversight (informed consent, independent safety oversight).
This is the latest FDA action implementing President Trump's April 2026 executive order, "Accelerating Medical Treatments for Serious Mental Illness," which "directed agencies to accelerate research into psychedelic medicine." The agency situates the RFI in a broader federal program: July 2026 final guidance (Psychedelic Drugs: Considerations for Clinical Investigations); an allowed early-phase IND for noribogaine (an ibogaine derivative) in alcohol use disorder; ARPA-H funding early-phase safety/efficacy trials; NIDA funding ibogaine research for opioid use disorder — with HHS "prioritizing two initial populations for federally supported research: adults with OUD and adults with post-traumatic stress disorder (PTSD)."
What to watch: whether the docket input (closing Nov 20) produces a concrete FDA trial-design pathway — and whether any ibogaine sponsor moves into an IND with the agency's stated parameters.