The Priority Review

Regulation Brief

FDA requests public comments on ibogaine trial design

FDA is opening a docket to receive comments on design elements for early-phase trials of ibogaine drug products, with a deadline of November 20, 2026. The request follows guidance issued July 14, 2026 and seeks input on dose selection, safety monitoring, eligibility criteria and other protocol elements.

Primary source

Federal Register notice, October 6, 2026

Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information

Read the source: Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information federalregister.gov

Machine-summarized from the source above; not independently reported. How we use automation