FDA seeks public input on ibogaine clinical trials

FDA requests public input on ibogaine trials

The U.S. Food and Drug Administration (FDA) is calling for public input on the design of early-phase clinical trials for ibogaine, a psychoactive substance under investigation for its potential therapeutic benefits. This request for information (RFI) aims to gather data on trial design, dosing, safety monitoring, and eligibility criteria, according to a recent announcement.

What the FDA is seeking

The FDA's RFI seeks detailed comments on several aspects of ibogaine trial development. Key areas include dose selection and escalation, clinical care settings, safety monitoring, eligibility criteria, and ethical oversight. Michael Davis, M.D., Ph.D., Director of the FDA Center for Drug Evaluation and Research, emphasized the importance of rigorous scientific investigation for patients with conditions unresponsive to existing treatments. The agency is particularly interested in safety measures for cardiac and neurological events and ethical considerations like informed consent.

Regulatory context

The FDA's initiative is part of a broader federal effort to advance research into psychedelic medicines. In July 2026, the FDA finalized guidance for clinical investigations of psychedelic drugs. Additionally, an early-phase study of noribogaine hydrochloride, an ibogaine derivative, has been approved under an Investigational New Drug application for alcohol use disorder treatment. The Department of Health and Human Services (HHS), through the Advanced Research Projects Agency for Health (ARPA-H), is also funding early-phase research to gather safety and efficacy data.

Why it matters

The FDA's request for public input is crucial as it could shape the future development of ibogaine as a therapeutic option. Federally supported research is currently prioritizing adults with opioid use disorder and post-traumatic stress disorder (PTSD), reflecting the serious nature of these conditions. The information gathered could help assess the potential uses, benefits, and risks of ibogaine drug products.

Next steps

The public has until November 20, 2026, to submit comments, data, or information following the publication in the Federal Register. This feedback will be instrumental in guiding the FDA's approach to ibogaine research.

The FDA's initiative underscores its commitment to advancing evidence-based research into psychedelic medicines, with a focus on patient safety and scientific rigor.