We Submitted a Public Comment to the FDA on Ibogaine Clinical Trial Design
On October 12, 2026, we submitted a formal public comment to the U.S. Food and Drug Administration as the Ibogaine Club Research Group, responding to Docket No. FDA-2026-N-10429, the Agency's request for information on design and safety considerations for clinical trials involving ibogaine drug products. The comment was reviewed and posted publicly on regulations.gov as comment FDA-2026-N-10429-0023.
We are not a pharmaceutical sponsor, a treatment center, or a clinical research organization. Our standing to comment came from a different vantage point: years spent indexing published ibogaine case reports, reviewing the intake and cardiac-safety protocols independently operating treatment centers worldwide have converged on, and tracking the registered interventional studies on ibogaine listed on ClinicalTrials.gov. That is the same research base behind the cardiac risk calculator and research library we maintain on this site.
What We Told the FDA
The Agency asked for comment across four areas: study design and patient populations, dose selection, safety considerations, and ethical/oversight considerations. Our submission focused heaviest on safety, because that is where our case-report research base is most directly useful. The core points:
- Cardiac risk stratification should be a non-waivable enrollment precondition, not a post-hoc safety covariate. Across the clinic protocols we have reviewed, cardiac history and current QT-prolonging medication use are the most common reasons legitimate providers decline a patient, more common than any psychiatric exclusion.
- Amiodarone and other long-half-life QT-prolonging drugs should be a categorical exclusion, not a relative contraindication, given amiodarone's 40-55 day elimination half-life makes it effectively unwashoutable on any practical trial screening timeline.
- There is no standardized unit of ibogaine dosing across the existing literature. Case reports report dose as mg/kg of HCl salt, mg/kg of total alkaloid extract, or simply "flood dose" with no disclosed milligram equivalent at all. We recommended the Agency mandate a standardized mg/kg ibogaine-HCl-equivalent reporting unit with verified alkaloid-content assay, plus CYP2D6 genotyping prior to dose-escalation given noribogaine clearance depends substantially on CYP2D6 activity.
- The published fatality case literature is unusually consistent about the mechanism of harm. We cited nine published case reports and series (Meisner et al. 2016, Mazoyer et al. 2013, Mestre et al. 2024, and others) and noted that we are not aware of a single published fatality occurring in a setting that performed pre-treatment ECG screening, excluded patients on baseline QTc or electrolyte abnormality, and maintained continuous telemetry with on-site defibrillation capability throughout dosing.
- Informed consent materials should disclose the denominator problem directly: no existing study allows calculation of a reliable ibogaine-associated mortality rate, because the total number of people who have ever taken ibogaine worldwide is fundamentally unknown. We recommended against consent language that implies a quantified risk percentage without disclosing that limitation.
The full comment, including our complete citation list and nine specific recommendations, is publicly readable on regulations.gov under FDA-2026-N-10429-0023. The docket remains open for public comment through November 20, 2026, and anyone, including other researchers, clinicians, or patients, can still submit their own comment directly to the Agency.
Why We Did This
This docket is the clearest signal yet that domestic ibogaine clinical trials are moving from hypothetical to planned. The protocol decisions made now, around cardiac screening thresholds, dose-reporting standards, and informed consent language, will shape how the first FDA-regulated ibogaine trials in the U.S. are actually run. We sit at an unusual intersection: we talk to people who are seeking ibogaine treatment today, in the complete absence of a domestic regulatory pathway, and we have spent years cataloging what the international clinic infrastructure independently converged on for safety without any regulator telling it to. We think that pattern, what protocols clinics landed on with no shared guidance, is a useful data point for the Agency, and we said so on the record.