FDA will issue formal guidance specifically addressing cardiac monitoring requirements for ibogaine and ibogaine analog trials by Q2 2027.

The FDA (the US drug regulator) will write down specific rules about how companies must monitor people's hearts during ibogaine trials. This matters because ibogaine can affect heart rhythm in ways that could be dangerous, and right now there are no clear federal rules about what doctors have to check.

Accumulating QT/arrhythmia literature on ibogaine, combined with multiple active INDs, creates regulatory pressure to establish safety standards proactively. FDA has clear precedent for issuing compound-class guidance when cardiac signals emerge across multiple submissions. The 6-12 month delay estimate for active INDs is plausible but speculative and was removed from the falsifiable claim to keep it clean.