The U.S. Food and Drug Administration (FDA) has announced a request for information (RFI) regarding the design of early-phase clinical trials for ibogaine drug products. The agency is seeking public comments, data, and information to inform the development of protocols for this research.
The RFI focuses on several specific protocol elements, including dose selection and escalation, the appropriate care setting, safety monitoring, eligibility criteria, and stopping rules. The FDA is particularly interested in approaches that prioritize patient safety while addressing the serious safety concerns associated with ibogaine.
According to the announcement, the agency is seeking input in four primary areas: general study design, including appropriate patient populations; dose selection and escalation, which may involve small, sequential dose-ascending groups and a starting dose not exceeding 10 mg/kg; safety considerations, such as monitoring for cardiac and neurologic adverse events; and ethical and oversight considerations, including informed consent and independent safety oversight.
This action is part of a broader federal initiative to advance psychedelic medicine. It follows President Trump’s April 2026 executive order on Accelerating Medical Treatments for Serious Mental Illness. The FDA has also issued finalized guidance for industry regarding psychedelic drugs and has allowed an early-phase clinical study of noribogaine hydrochloride to proceed under an Investigational New Drug application for alcohol use disorder.
The Department of Health and Human Services (HHS) is supporting this research through the Advanced Research Projects Agency for Health (ARPA-H) and the National Institute on Drug Abuse (NIDA). HHS is prioritizing two initial populations for federally supported research: adults with opioid use disorder (OUD) and adults with post-traumatic stress disorder (PTSD).
The public has 45 days following publication in the Federal Register to submit comments. Stakeholders are encouraged to submit comments electronically at regulations.gov by searching for Docket No. FDA-2026-N-10429. Written submissions may be sent to the Dockets Management Staff at the FDA headquarters in Rockville, Maryland. The comment period closes on Friday, November 20, 2026.
