FDA Opens Public Input

The agency is seeking comments, data and evidence to help shape how early-phase ibogaine clinical trials could be designed.

What Researchers May Examine

The request asks about study populations, dose selection and escalation, care settings, safety monitoring, stopping rules and oversight.

Four Areas in the Request

FDA groups topics into study design, dosing, safety considerations, and ethics and oversight, including informed consent and independent safety oversight.

Safety Is a Research Focus

Trial safeguards include monitoring cardiac and neurologic adverse events, setting eligibility criteria, and defining when a study should stop.

Priority Groups for Federal Research

HHS is prioritizing adults with opioid use disorder and adults with PTSD for initial federally supported research.

Other Federal Research Efforts

HHS supports early-phase safety and efficacy data collection, while NIDA funds research on ibogaine’s potential use for opioid use disorder.

Comment Deadline: November 20

The FDA says comments are due November 20, 2026; late submissions will not be considered, and electronic comments go through regulations.gov.