Ibogaine cardiac safety will remain the primary regulatory gating factor for all FDA and Congressional ibogaine progress through at least mid-2027.

The cardiac (heart) safety problem with ibogaine — specifically QT prolongation — will be the main reason the FDA doesn't approve ibogaine or clear new trials for at least 18 more months. No new research has emerged to prove the heart risk is safe or manageable, so the safety concern stays locked in place as the blocking point. Ibogaine advocates are pushing, but the FDA won't move until the heart problem is resolved.

QT prolongation data is now sufficient to anchor FDA safety reviews and Congressional risk calculus. No counterbalancing safety data resolving the cardiac signal is expected within 12 months. Veteran advocacy pressure exists but is insufficient to override a documented safety signal at the FDA level. The gating factor claim is falsifiable: it resolves NO if FDA approves an IND with standard monitoring, or if a safety study publishes exculpatory data.