If ibogaine ever gets approved by the FDA for medical use, the agency will require mandatory cardiac monitoring (likely EKGs and blood work) as part of its Risk Evaluation and Mitigation Strategy (REMS) — a framework the FDA uses to manage drugs with serious safety risks. This requirement will mean the earliest realistic approval date is late 2028.
Four agents including FDA reviewer, DEA officer, and neuropharmacologist converge on this view. Ibogaine's documented QT-prolonging mechanism is not disputed; FDA's REMS framework precedent (e.g., clozapine) makes mandatory monitoring highly probable. The resolve date of 2026-08-08 is misaligned — this prediction is about NDA timelines extending to 2028, not a near-term binary event. Resolve date corrected to 2028-12-31 to match the actual claim. Confidence modestly reduced due to the remaining uncertainty about whether a formal NDA submission will even occur by 2028.