FDA seeks input on safeguards for early ibogaine trials
The agency is asking about trial design, dosing, safety monitoring and oversight, with comments due November 20.
Event / data period: 2026-10-05
Published: · Updated:
The FDA issued a request for information on how early-phase clinical trials of ibogaine products should be designed. It is seeking evidence and feedback on patient eligibility, dose escalation, care settings, stopping rules, safety monitoring and independent oversight.
The agency highlighted cardiac and neurologic risks and said a proposed starting dose should be supported by available evidence and not exceed 10 milligrams per kilogram. The request is for input on research design, not an approval of ibogaine treatment; the comment period is scheduled to close November 20, 2026.
Data
FDA information request and comment timeline
The FDA information request and deadline stated in the release.
- · Occurred
FDA information request issued
Request for views and data on early ibogaine trial design.
- · Scheduled
Comment period closes
FDA says late comments will not be considered.
Methodology
The date and action are transcribed from FDA. The future deadline is source-stated and does not indicate a drug approval or trial result.
Updated:
Subjects and places
Subject proposals
- HealthSuggested
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