FDA Requests Public Feedback on Designing Early-Phase Trials for Psychedelic Drug Ibogaine

The U.S. Food and Drug Administration announced it is seeking comments from the public on how to structure early-phase clinical studies of ibogaine, a plant-derived psychoactive compound.

The agency’s request aims to gather input on trial design elements such as dosing, safety monitoring, and endpoints that could clarify ibogaine’s potential therapeutic applications.

By opening the comment period, the FDA hopes to ensure that any future studies are scientifically rigorous and address regulatory concerns, while also considering the growing interest in psychedelic therapies.