Ibogaine (a plant-derived compound) causes a known heart rhythm problem called QT prolongation—the time it takes your heart's electrical system to reset after each beat. The FDA has documented adverse events and will require mandatory EKG (heart monitoring) before patients can receive ibogaine in clinical trials. This adds 12–18 months to the timeline because the FDA has to write new safety rules, and study teams have to redesign their protocols to include the monitoring.
Documented QT prolongation adverse events in ibogaine literature and FDA's own adverse event surveillance create regulatory obligation to issue formal guidance. Multiple cardiac safety papers published in close succession signal a literature inflection point that FDA reviewers cannot ignore. Mandatory QT monitoring requirements are a predictable regulatory response. Confidence maintained at 0.75; the 12-18 month delay estimate is plausible but the exact timeline and scope of guidance are uncertain.