The FDA (the US drug regulator) will publicly release a formal safety alert about ibogaine's risk of irregular heartbeats before allowing clinical trials to expand. This happens because the drug causes a measurable change in heart electrical activity called QT prolongation. The delay matters because it pushes any potential approval years further away.
QT prolongation and ventricular arrhythmia data are well-documented in peer-reviewed literature and FDA has a structural mandate to issue precautionary guidance when cardiac risk signals emerge from Schedule I compounds entering clinical development. Historical precedent (e.g., MDMA cardiac scrutiny) supports this pattern. The 12-18 month delay estimate is plausible given FDA's guidance issuance timelines. Confidence slightly trimmed: no IND pathway expansion is currently imminent, making the conditional framing harder to falsify on the exact timeline specified.