The Priority Review

Tag

ibogaine

2 stories

  1. Regulation

    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.

  2. Regulation

    FDA seeks public input to support ibogaine research

    The FDA issued a request for information (RFI) to gather comments on early-phase clinical trial design for ibogaine drug products, including dose selection, safety monitoring and ethical oversight. Stakeholders have 45 days to submit comments, with the deadline on Friday, November 20, 2026.