WASHINGTON, D.C. — The U.S. Food and Drug Administration is seeking public input on safety requirements and clinical trial designs for ibogaine, a psychedelic compound being investigated for opioid use disorder and post-traumatic stress disorder, as federal agencies expand research into treatments for serious mental health conditions.
The agency is considering protocols for early-stage studies that would address dosing, patient eligibility, cardiac and neurological monitoring, and independent safety oversight. The consultation reflects concerns about the compound’s risks as researchers evaluate its potential therapeutic applications.
The FDA’s request for information follows an April 2026 executive order directing federal agencies to accelerate research into psychedelic medicines for serious mental illness.
“With ibogaine, there are important scientific questions as well as serious safety concerns,” said Michael Davis, director of the FDA’s Center for Drug Evaluation and Research. “We are seeking high-quality data and input that can help inform clinical research while putting patient safety first.”
The agency is evaluating whether initial clinical trials should use small groups of participants receiving sequentially increasing doses, with starting doses supported by available evidence and not exceeding 10 milligrams per kilogram of body weight.
Other considerations include appropriate treatment settings, criteria for selecting participants, conditions requiring a trial to stop, and safeguards against cardiac and neurological adverse events.
The FDA is also seeking recommendations on informed consent procedures and independent monitoring arrangements intended to protect participants in early-stage research.
Federal health officials have identified adults with opioid use disorder and adults with post-traumatic stress disorder as the initial priority populations for federally supported ibogaine research.
The Department of Health and Human Services, through the Advanced Research Projects Agency for Health, is funding a program to collect safety and efficacy data through early-phase clinical trials.
Separately, the National Institute on Drug Abuse is financing research into ibogaine as a potential treatment for opioid use disorder.
The FDA has also permitted an early-stage clinical study of noribogaine hydrochloride, an ibogaine derivative, to proceed under an Investigational New Drug application for potential treatment of alcohol use disorder.
That authorization allows the investigational study to proceed but does not constitute approval of the compound as a treatment.
The latest consultation builds on FDA guidance finalized in July 2026, titled Psychedelic Drugs: Considerations for Clinical Investigations, which outlines general expectations for companies developing psychedelic medicines.
The agency said public submissions could help determine how clinical studies should balance potential therapeutic benefits against known and emerging safety concerns.
Researchers, clinicians, drug developers and other interested parties have until Friday, November 20, 2026, to submit comments.
Submissions can be filed electronically at regulations.gov under Docket No. FDA-2026-N-10429.
Written comments may also be mailed to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
The FDA will not consider submissions received after the deadline.
The information collected will help inform the agency’s approach to early-phase ibogaine research, including the safeguards required before broader clinical development can proceed.
Support the local news that supports Chester County. MyChesCo delivers reliable, fact-based reporting and essential community resources—free for everyone. If you value that, click here to become a patron today.