The Ibogaine Club Research Group, an independent research resource focused on ibogaine safety data and treatment center protocols, has submitted a formal public comment to the U.S. Food and Drug Administration in response to Docket No. FDA-2026-N-10429. The comment addresses the agency’s Request for Information on design and safety considerations for clinical trials involving ibogaine drug products.
Submitted on October 12, 2026, and posted publicly as comment FDA-2026-N-10429-0023, the filing responds to all four areas identified by the FDA: general study design and patient populations, dose selection and escalation, safety considerations, and ethical and oversight considerations. The docket remains open for additional public comments through November 20, 2026.
The group’s recommendations center on cardiac risk management. Drawing from indexed peer-reviewed literature, registered clinical trials, and a review of intake and safety protocols used by independently operating treatment centers, the comment argues that cardiac risk stratification—including a 12-lead ECG, electrolyte panel, and medication review—should be a non-waivable precondition for enrollment rather than a post-hoc safety covariate. It further recommends treating amiodarone and other long-half-life QT-prolonging agents as categorical exclusions, given the impracticality of adequate washout within typical trial screening windows.
Additional recommendations include:
- Mandatory standardized dose reporting in mg/kg ibogaine HCl-equivalent with verified alkaloid-content assay;
- CYP2D6 genotyping prior to dose-escalation decisions, reflecting the enzyme’s role in noribogaine clearance;
- Continuous cardiac telemetry through an extended post-dosing observation period;
- Explicit disclosure in informed consent materials that no reliable ibogaine-associated mortality incidence rate can currently be calculated, because the total number of people who have ever taken the compound worldwide is unknown;
- Separate monitoring criteria and stopping rules for psychiatric serious adverse events, distinct from cardiac events.
“Across the published fatality case literature and the protocols used by legitimate treatment centers, the same pattern appears repeatedly: the absence of pre-treatment cardiac screening and continuous monitoring is the common factor in serious harm,” said Mara Ellison, Chief Medical Researcher at the Ibogaine Club Research Group. “These are practical, evidence-based elements that independent providers have already converged on in the absence of formal regulatory guidance. We believe they should inform the design of controlled trials.”
The full comment, including a summary table of published case reports and nine specific recommendations, is available on regulations.gov:
https://www.regulations.gov/comment/FDA-2026-N-10429-0023
A detailed summary of the submission and the reasoning behind the recommendations is published on the Ibogaine Club website:
https://ibogaine.club/blog/fda-public-comment-ibogaine-trial-safety
The docket remains open for public comment until November 20, 2026:
https://www.regulations.gov/docket/FDA-2026-N-10429
About Ibogaine Club
Ibogaine Club (ibogaine.club) is an independent directory and research resource that indexes verified ibogaine treatment centers worldwide, summarizes peer-reviewed literature on the compound, tracks legal status by country, and provides publicly accessible safety tools, including a cardiac risk calculator. The Ibogaine Club Research Group does not provide medical treatment, sell ibogaine, or hold financial interests in any treatment center. Its work focuses on aggregating and analyzing publicly available clinical, safety, and protocol data.
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