FDA seeks public input on ibogaine research

The U.S. Food and Drug Administration on Oct. 5, 2026, issued a request for information (RFI) seeking public input to guide clinical research on ibogaine, a psychoactive compound being studied as a treatment for substance use and psychiatric disorders.

What the RFI covers

The agency is asking researchers, clinicians, patients and other stakeholders to weigh in on how ibogaine trials should be built and run. Topics include:

• Study design, including how trials should be structured to generate reliable evidence.
• Dosing, with a proposed cap of 10 mg/kg on starting doses and small ascending-dose groups.
• Safety monitoring, particularly cardiac and neurologic monitoring, given ibogaine's known risks.
• Eligibility criteria for who can safely enroll.
• Stopping rules for halting dosing or a trial when safety signals appear.
• Informed consent and oversight of participants and study sites.

Policy context

The FDA ties the RFI to an April 2026 executive order directing federal agencies to accelerate research into psychedelic treatments. The request builds on related federal actions, including:

• FDA guidance issued in July 2026 on psychedelic clinical investigations.
• An investigational new drug (IND) application for noribogaine, ibogaine's primary metabolite, in alcohol use disorder.
• Research funding from ARPA-H and the National Institute on Drug Abuse (NIDA).

The agency identified opioid use disorder (OUD) and post-traumatic stress disorder (PTSD) as priority populations for ibogaine research.

How to comment

Public comments can be submitted to Docket No. FDA-2026-N-10429 at regulations.gov. The comment period closes Nov. 20, 2026.