FDA issues request for information on early-phase ibogaine trial design
The FDA announced a request for information (RFI) to gather input on how to design early-phase clinical trials of ibogaine drug products.
The agency is looking for comments on protocol elements such as dose selection and escalation, patient eligibility, safety monitoring, and stopping rules.
The move follows an executive order from April 2026 that directs agencies to speed up research on psychedelic medicines for serious mental illness.
FDA officials emphasized the need for high-quality data while prioritizing patient safety as the agency considers the scientific and safety questions surrounding ibogaine.
This writeup was produced by pharmadog from original reporting by fda press.
Original headline: “FDA Seeks Public Input to Support Ibogaine Research”
read at fda press ↗
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