FDA will issue formal guidance on QT monitoring requirements for ibogaine by mid-2027, and this guidance will be cited as a primary reason for delay in at least one IND progress report filed before December 2027.

The FDA will publish formal rules about heart monitoring for ibogaine, and at least one company running an ibogaine trial will later tell the FDA that this new guidance is the reason their trial got delayed. This is similar to the first prediction but focuses on whether the new rules actually slow down drug approvals.

This is a duplicate of prediction #1 with a slightly different emphasis on IND delays. The cardiac literature signal is real. The question is whether FDA acts via formal guidance versus informal reviewer feedback or clinical hold letters, which are more common and faster. Formal guidance within 13 months remains unlikely.