September 14, 2026 · ibogaine research update October 5, 2026 · FDA / Psychedelic drugs / Ibogaine / Therapeutic development
FDA adds ibogaine trial-design RFI to psychedelic-drug development push
FDA issued an October 5 request for information on early-phase clinical-trial design for ibogaine drug products, seeking input on patient selection, dose escalation, cardiac and neurologic safety monitoring, stopping rules, informed consent and independent oversight. Comments are due November 20. The RFI is a research and drug-development step: it does not approve ibogaine, establish effectiveness, create general legal access or change federal controlled-substance scheduling.
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