Overview
- The University of Miami handed its original 1994 ibogaine Investigational New Drug application to the federal government, President Trump announced Tuesday.
- The transfer follows the president’s April executive order that directed new funding and priority for psychedelic research and singled out ibogaine by name.
- The FDA has already opened early U.S.-based trials of an ibogaine-derived drug after the April order, but controlled clinical evidence on safety and effectiveness remains limited.
- Ibogaine is still classified as a Schedule I substance in the United States, and federal agencies have not yet made public how they will use the donated application to influence study design or approval paths.
- State measures in Mississippi, Oklahoma and Tennessee and long-standing off‑label use abroad show strong public demand for treatments, and the transfer could speed trials that affect veterans and people seeking alternatives to existing opioid therapies.