FDA Seeks Public Input on Early-Phase Clinical Trial Design and Safety for Ibogaine Drug Products

The U.S. Food and Drug Administration is requesting public comments, data, and information on approaches for designing early-phase clinical trials of ibogaine drug products. The request focuses on general study design, patient populations, dose selection and escalation, care settings, cardiac and neurologic safety monitoring, eligibility criteria, stopping rules, informed consent, and independent safety oversight. The FDA is considering sequential dose-ascending groups with a starting dose supported by available evidence and not exceeding 10 mg/kg. The agency says the process is intended to advance research while addressing serious safety concerns and unmet needs. The request follows a 2026 executive order on psychedelic medicine and complements federal research priorities involving adults with opioid use disorder and post-traumatic stress disorder. Comments are due by November 20, 2026, under Docket No. FDA-2026-N-10429.