FDA will issue formal written guidance requiring cardiac monitoring protocols (including QT-interval surveillance) as a prerequisite for any ibogaine or ibogaine-analog IND submission, before 2027-01-15.

Ibogaine, a plant medicine some people use for addiction, can affect the heart's electrical rhythm. The FDA (the US drug regulator) has seen enough published research showing this risk that it will issue formal written guidance requiring anyone testing ibogaine to monitor patients' hearts closely. This is standard FDA practice when a drug shows a consistent safety signal.

Published QT-prolongation and arrhythmia data for ibogaine have reached a density that FDA's safety division treats as a compound-class signal. FDA's standard regulatory response to such signals is formal guidance or a safety communication, not case-by-case IND holds. The agency has precedent for issuing cardiac-safety guidance on novel CNS compounds within 12-18 months of signal consolidation. No dissenting agents were identified. Confidence held at 0.79 (trimmed from 0.81): formal guidance issuance timelines can slip, and the agency could address this via individual IND clinical holds rather than a formal guidance document, which would make this technically unresolvable as written. Resolve criterion: publicly posted FDA guidance document explicitly referencing ibogaine cardiac monitoring requirements.