FDA Seeks Input on Early-Phase Ibogaine Trial Design and Safety

The U.S. Food and Drug Administration has issued a request for information on approaches to designing early-phase clinical trials of ibogaine drug products. The agency seeks comments and data on dose selection and escalation, care settings, safety monitoring, eligibility criteria, stopping rules and safety oversight. The announcement is a regulatory consultation, not a report of trial findings.

The FDA highlighted both unmet treatment needs and serious safety concerns surrounding ibogaine. The Department of Health and Human Services is prioritizing adults with opioid use disorder and adults with post-traumatic stress disorder for federally supported research. ARPA-H is funding a program to collect safety and efficacy data through early-phase trials, while the National Institute on Drug Abuse is funding research into ibogaine for opioid use disorder.

The agency also reported that it has allowed an early-phase study of noribogaine hydrochloride, an ibogaine derivative, to proceed under an Investigational New Drug application for potential treatment of alcohol use disorder. Permission to conduct research does not establish clinical benefit or constitute marketing approval; the announcement provides no sample sizes or efficacy estimates.

Comments are due November 20, 2026, under Docket No. FDA-2026-N-10429 at regulations.gov. The FDA says submissions may help inform drug development and understanding of ibogaine’s potential benefits and risks.