The US Is Funding Its First Ibogaine Trials. The FDA Wants 36 Hours of Cardiac Monitoring First.
HHS is funding the first-ever government-backed ibogaine trials, through the Advanced Research Projects Agency for Health (ARPA-H) and the National Institute on Drug Abuse, targeting opioid use disorder and PTSD. It's a direct result of President Trump's April executive order, which committed $50 million to federal ibogaine research as part of a broader push to accelerate psychedelic drug development across agencies.
Before any of that money reaches a patient, the FDA opened a public comment docket (No. FDA-2026-N-10429, open through Nov 20) laying out just how seriously it's treating ibogaine's known cardiac risk. The proposed trial design requires continuous heart-rhythm monitoring for up to 36 hours after a single dose, in an inpatient unit equipped for life-threatening arrhythmia — a physician-led advanced-cardiac-life-support team, bedside defibrillator, emergency pacing, and ventilator support all on standby. Monitoring continues until the QT interval returns near baseline; if it stays above 500 milliseconds for more than two days, the study has to pause. Anyone with structural heart disease, a baseline QT above 430ms, or a personal or family history of arrhythmia or sudden cardiac death is excluded outright, and starting doses are capped at 10 mg/kg.
None of this is hypothetical caution. We've already covered the cardiac signal that stalled DemeRx's own ibogaine HCl program after a Phase 1 participant showed QTc prolongation — this FDA proposal reads like the regulatory response to exactly that kind of result, applied before the next trial even starts rather than after.