The FDA announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches.

Ibogaine is a psychedelic substance derived from the root bark of the iboga shrub from Central Africa. This RFI marks the latest FDA action to advance an April 2026 executive order on Accelerating Medical Treatments for Serious Mental Illness, which directed agencies to accelerate research into psychedelic medicine.

The RFI seeks comments, data, and information on specific protocol elements relevant to ibogaine drug development, including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules and safety oversight.

The FDA is seeking comments, data, and information in four primary areas:

• General study design
• Dose selection and escalation
• Safety considerations
• Ethical and oversight considerations

The public will have 45 days following publication in the Federal Register to submit comments, data or information to the docket. Stakeholders are encouraged to submit comments electronically at regulations.gov by searching for Docket No. FDA-2026-N-10429. The comment period closes Friday, November 20, 2026.

The information received through this RFI may help the agency better understand the potential uses, benefits and risks of ibogaine drug products and inform approaches to drug development.