Federal Register #2026-20427

FDA seeks input on safety and design of ibogaine clinical trials

The FDA is seeking public input on the safety and design of early-phase clinical trials involving ibogaine drug products, not seeking products or services for purchase. - Government buyer: U.S. Department of Health and Human Services (HHS), through the Food and Drug Administration (FDA); no specific office is identified. - Purpose: HHS funding supports ibogaine clinical development, with initial federally supported studies expected to involve adults with opioid use disorder (OUD) and post-traumatic stress disorder (PTSD). - Trial-design topics: FDA seeks input on eligibility and medication restrictions, dose selection and escalation, trial settings, safety monitoring, stopping rules, and independent safety oversight. Preliminary considerations include a single dose, sequential escalation beginning at no more than 10 mg/kg, inpatient cardiac monitoring and emergency safeguards, and extended neurologic and cognitive follow-up. - Notable risks: The request highlights cardiac and neurological safety considerations. Input may inform FDA’s review of Investigational New Drug Applications involving ibogaine. - No procurement: No ibogaine manufacturer, part number, quantity, contract value, or product or service purchase is specified. - Other products and organizations appearing in the attachment: Pralidoxime chloride autoinjector (NDA 018986) is identified as held by Meridian Medical Technologies, Inc.; FAYUVI is identified as manufactured by Ultragenyx Pharmaceutical Inc.; and a dimethyl fumarate delayed-release capsule notice names Upsher-Smith Laboratories, LLC, as U.S. Agent for Sawai USA, Inc. These are separate FDA notice items, not products requested for purchase.

Description

The FDA is seeking comments, data, and information on approaches to designing early-phase clinical trials of ibogaine drug products. The first federally supported trials are expected to study adults with opioid use disorder and adults with post-traumatic stress disorder. Requested input concerns protocol elements such as dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules, and safety oversight. The FDA will consider responses when determining whether and how these elements should inform its review of Investigational New Drug Applications involving ibogaine; comments are due November 20, 2026.

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