FDA seeks public input on how to design early trials of ibogaine
Oct. 5, 2026 — The Food and Drug Administration asked for public input on approaches it is considering for early-phase clinical trials of ibogaine, a psychedelic compound, including dose selection and escalation, the care setting, safety monitoring, who may enroll, and when a trial should stop. The request is the latest FDA step under President Trump's April 2026 executive order directing agencies to speed research into psychedelic medicine for serious mental illness.
"With ibogaine, there are important scientific questions as well as serious safety concerns," said Dr. Michael Davis, director of the FDA's Center for Drug Evaluation and Research. The agency said it wants data and input that can inform research "while putting patient safety first."
Comments are due Friday, Nov. 20, 2026, at regulations.gov.
The wall: Which safety concerns the FDA has in mind, and how the trial approaches would address them, are set out in the request itself, to be published in the Federal Register.
Tier: Confirmed (based on the FDA's announcement)
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