FDA Seeks Public Input to Advance Ibogaine Research for Serious Mental Illnesses

The U.S. Food and Drug Administration (FDA) has issued a request for information (RFI) to gather public input on approaches for designing early-phase clinical trials of ibogaine drug products. This initiative is a direct result of President Trump's April 2026 executive order aimed at accelerating medical treatments for serious mental illness, specifically through psychedelic medicine research. The FDA is seeking data and comments on various aspects of ibogaine drug development, including study design, dose selection, safety considerations, and ethical oversight, acknowledging the significant safety concerns associated with the substance.