FDA seeks public input on ibogaine clinical trial design
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The Food and Drug Administration announced a request for information describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products. 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.
Michael Davis, Director of the FDA Center for Drug Evaluation and Research, said patients facing serious conditions that have not responded to existing treatments deserve rigorous scientific investigation of promising new approaches. Davis said with ibogaine there are important scientific questions as well as serious safety concerns. The agency is seeking high-quality data and input to help inform clinical research while putting patient safety first.
The RFI covers four primary areas. These are general study design including appropriate patient populations, dose selection and escalation including a starting dose not exceeding 10 mg/kg, safety considerations including monitoring for cardiac and neurologic adverse events, and ethical and oversight considerations including informed consent and independent safety oversight. HHS is prioritizing two initial populations for federally supported research: adults with opioid use disorder and adults with post-traumatic stress disorder.
The agency is accepting public comments for 45 days following publication in the Federal Register. Comments may be submitted at regulations.gov by searching for Docket No. FDA-2026-N-10429. The comment period closes Friday, November 20, 2026. Late comments will not be considered.
The RFI supports President Trump's April 2026 executive order on Accelerating Medical Treatments for Serious Mental Illness, which directed agencies to accelerate research into psychedelic medicine. HHS, through the Advanced Research Projects Agency for Health, is funding a program to collect safety and efficacy data through early-phase clinical trials. The National Institute on Drug Abuse is funding research on ibogaine for the potential treatment of opioid use disorder.
The FDA issued finalized guidance for industry titled Psychedelic Drugs: Considerations for Clinical Investigations in July 2026. The agency has also allowed an early-phase clinical study of noribogaine hydrochloride, a derivative of ibogaine, to proceed under an Investigational New Drug application as a potential treatment for alcohol use disorder.
