FDA News Release
FDA Seeks Public Input to Support Ibogaine Research
- For Immediate Release:
The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches. The RFI seeks comments, data, and information on specific protocol elements relevant to ibogaine drug development, including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules and safety oversight. This RFI marks the latest FDA action to advance President Trump’s April 2026 executive order on Accelerating Medical Treatments for Serious Mental Illness, which directed agencies to accelerate research into psychedelic medicine.
“Patients facing serious conditions that have not responded to existing treatments deserve rigorous scientific investigation of promising new approaches,” said Michael Davis, M.D., Ph.D., Director of the FDA Center for Drug Evaluation and Research. “With ibogaine, there are important scientific questions as well as serious safety concerns. We are seeking high-quality data and input that can help inform clinical research while putting patient safety first.”
The FDA is seeking comments, data and information in four primary areas:
- General study design, including appropriate patient populations;
- Dose selection and escalation, including the proposed use of small, sequential dose-ascending groups and a starting dose justified by available data and not exceeding 10 mg/kg;
- Safety considerations, including monitoring for cardiac and neurologic adverse events and other safeguards for clinical trials; and
- Ethical and oversight considerations, including informed consent and appropriate independent safety oversight.
The FDA recognizes the seriousness of the conditions and unmet needs that patients seeking ibogaine treatments face. The information received through this RFI may help the agency better understand the potential uses, benefits and risks of ibogaine drug products and inform approaches to drug development.
The FDA has been working across the federal government to support the responsible development of ibogaine drug products through careful evidence-based processes. In July 2026, the FDA issued its finalized guidance for industry, Psychedelic Drugs: Considerations for Clinical Investigations, which provides general considerations for sponsors developing psychedelic drugs. The FDA has also allowed an early-phase clinical study of noribogaine hydrochloride, a derivative of ibogaine, to proceed under an Investigational New Drug application as a potential treatment for alcohol use disorder.
As part of the whole-of-government approach to advance psychedelic drug development, HHS, through the Advanced Research Projects Agency for Health (ARPA-H), is funding a program to collect safety and efficacy data through early-phase clinical trials, and the National Institute on Drug Abuse (NIDA) is funding research on ibogaine for the potential treatment of opioid use disorder (OUD). Based on available data and the seriousness of the conditions, HHS is prioritizing two initial populations for federally supported research: adults with OUD and adults with post-traumatic stress disorder (PTSD).
The public will have 45 days following publication in the Federal Register to submit comments, data or information to the docket. Stakeholders are encouraged to submit comments electronically at regulations.gov by searching for Docket No. FDA-2026-N-10429. Written/paper submissions may also be sent to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
The comment period closes Friday, November 20, 2026. Late comments will not be considered.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.