FDA Seeks Public Input to Support Ibogaine Research

The FDA issued a request for information on approaches it is considering for designing early-phase clinical trials of ibogaine drug products, covering dose selection and escalation, care setting, safety monitoring, eligibility, stopping rules and safety oversight. Proposed trial elements include small, sequential dose-ascending groups with a starting dose not exceeding 10 mg/kg, and monitoring for cardiac and neurologic adverse events. Comments can be submitted for 45 days via Docket No. FDA-2026-N-10429, closing November 20, 2026, and may inform FDA approaches to ibogaine drug development.