FDA will issue formal ibogaine cardiac safety guidance requiring mandatory cardiac screening protocols before any IND expansion, delaying veteran-focused trials by 12-18 months

The FDA (US drug regulator) will require companies to do cardiac screening tests before expanding ibogaine studies, because recent research shows ibogaine can affect heart rhythm. This slows down trials — especially ones for veterans — by over a year.

Recent dual ibogaine cardiac safety papers on QT prolongation and arrhythmia provide FDA's safety division with documented grounds to impose enhanced cardiac monitoring requirements before IND expansion. Procedurally consistent with FDA's liability calculus on novel Schedule I compounds with known cardiotoxicity. The 12-18 month delay estimate is specific and testable against actual IND expansion timelines.