FDA seeks public input on ibogaine research

The U.S. Food and Drug Administration (FDA) is calling for public input on the design of early-phase clinical trials for ibogaine drug products, according to a recent announcement. This request for information (RFI) aims to gather comments, data, and insights on various protocol elements crucial for ibogaine drug development, including dose selection, safety monitoring, and ethical considerations.

What the FDA is seeking

The FDA's RFI focuses on four main areas: general study design, dose selection and escalation, safety considerations, and ethical oversight. The agency is particularly interested in feedback on patient populations, starting doses not exceeding 10 mg/kg, and monitoring for cardiac and neurological adverse events. These elements are critical for ensuring patient safety and advancing scientific understanding of ibogaine's potential therapeutic uses.

Regulatory context

This initiative is part of a broader effort to accelerate research into psychedelic medicine, following President Trump's April 2026 executive order on medical treatments for serious mental illnesses. Michael Davis, M.D., Ph.D., Director of the FDA Center for Drug Evaluation and Research, emphasized the need for rigorous scientific investigation into promising new approaches for patients with unmet medical needs.

In July 2026, the FDA released guidance for the industry on psychedelic drugs, outlining considerations for clinical investigations. The agency has also approved an early-phase study of noribogaine hydrochloride, a derivative of ibogaine, for alcohol use disorder.

Why it matters

The FDA's request for public input underscores the growing interest in ibogaine as a potential treatment for conditions like opioid use disorder (OUD) and post-traumatic stress disorder (PTSD). These conditions have significant unmet treatment needs, and ibogaine's potential benefits and risks are still being explored. The feedback collected will help shape future clinical trials and regulatory pathways for ibogaine drug products.

How to participate

Stakeholders have until November 20, 2026, to submit comments electronically via regulations.gov, referencing Docket No. FDA-2026-N-10429. Written submissions can also be sent to the FDA's Dockets Management Staff in Rockville, MD. Late comments will not be considered.

This RFI is part of a coordinated government effort to responsibly develop psychedelic drug products, with support from the Advanced Research Projects Agency for Health (ARPA-H) and the National Institute on Drug Abuse (NIDA).