FDA will issue a formal clinical hold or safety guidance on at least one ibogaine IND citing QT prolongation before end of 2026.

The FDA will formally halt or restrict at least one ibogaine drug trial (called a clinical hold) or issue safety guidance because of a cardiac problem called QT prolongation — a heartbeat irregularity that can cause sudden death. Ibogaine is known to affect the heart's electrical system, and researchers have already documented this risk in peer-reviewed studies. The FDA uses this evidence to trigger safety holds.

A growing body of peer-reviewed cardiac complication data — specifically QT prolongation — constitutes the evidentiary record FDA reviewers require to justify a clinical hold. QT prolongation is a documented regulatory tripwire across therapeutic classes. Active ibogaine INDs face this risk asymmetrically given the compound's known cardiac ion-channel effects. The question is timing and which program is first, not whether it will happen.