FDA will issue formal written guidance requiring mandatory cardiac screening (ECG, QTc baseline) for any ibogaine IND submitted or amended in 2026.

Ibogaine (a plant-derived drug being tested for addiction) can damage the heart in serious ways—the data is public and clear. The FDA (US drug regulator) will almost certainly demand that any company testing ibogaine in humans first does heart screening tests (an ECG baseline and QTc measurement) before those humans start the drug. This protects patients and shields the FDA from liability.

Published QT prolongation and cardiovascular fatality data create a clear evidentiary record FDA cannot ignore without liability exposure. Formal written guidance—distinct from informal reviewer feedback—is the measurable bar here. A full REMS designation is unlikely this fast; the prediction is narrowed to mandatory cardiac screening language in formal IND guidance, which is achievable by Q4 2026.