The U.S. Food and Drug Administration (FDA) has today shared how a potential domestic, early-phase clinical trial of ibogaine could shape up, via a 20-page document due to be published in the Federal Register tomorrow. Through ARPA-H and NIDA, the Department of Health and Human Services expects to fund the first federally supported trials of the drug in opioid use disorder and PTSD. But FDA is charting a cautious path, flagging cardiac concerns in humans and neurotoxicity seen in animal studies. Key features of FDA’s proposed trial design include: Participants enrolled in “sequential dose ascending groups”, 10 mg/kg cap Participants dosed one at a time, with potential dose increases from cohort to cohort considered “after appropriate review” Dosing takes place in an inpatient unit equipped for cardiac emergencies, with continuous cardiac monitoring Only fast and intermediate CYP2D6 metabolisers enrolled Participants stop certain medications, like opioid agonists and SSRIs Strict stopping rules and cognitive follow-up for 12 months The agency is now seeking public comments on its thinking around ibogaine drug development via a 45-day Request for Information.

Breaking: FDA Seeks Public Input on Ibogaine Drug Development This morning, FDA announced a request for information (RFI) covering early-stage clinical trials of ibogaine-based candidates. Specifically, the agency is soliciting public input in the form of comments, data, and information focused on four key areas: general study design, dose selection and escalation, safety considerations, and ethical and oversight considerations. Information may be submitted for 45 days from tomorrow, October 6th, when the RFI is set to be published in the Federal Register.