"Patients facing serious conditions that have not responded to existing treatments deserve rigorous scientific investigation of promising new approaches."
News|Articles|October 5, 2026
FDA Seeks Public Input on Early-Phase Clinical Trial Design for Ibogaine
Author(s)Andy Studna, Senior Editor
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Key Takeaways
- FDA seeks input on early-phase ibogaine protocols, spanning patient population selection, escalation schema with a proposed ≤10 mg/kg starting dose, and prespecified stopping rules and oversight.
- Cardiac and neurologic safety risks are central, driving emphasis on intensive monitoring, appropriate care settings, and independent safety oversight with robust informed-consent processes.
A new request for information asks for comments on dose selection, safety monitoring, eligibility criteria, and oversight approaches to support the responsible development of ibogaine drug products.
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The FDA has issued a request for information (RFI) seeking public input on approaches to early-phase clinical trial design for ibogaine drug products. The RFI covers specific protocol elements including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules, and safety oversight. Comments are due by November 20, 2026.1
The RFI marks the latest regulatory action flowing from
"Patients facing serious conditions that have not responded to existing treatments deserve rigorous scientific investigation of promising new approaches," said Michael Davis, MD, PhD, director of the FDA's Center for Drug Evaluation and Research (CDER), in an agency press release. "With ibogaine, there are important scientific questions as well as serious safety concerns. We are seeking high-quality data and input that can help inform clinical research while putting patient safety first."
The FDA is soliciting input across four primary areas: general study design including appropriate patient populations; dose selection and escalation, including a proposed starting dose not exceeding 10 mg/kg; safety considerations including monitoring for cardiac and neurologic adverse events; and ethical and oversight considerations including informed consent and independent safety oversight.
The RFI is part of a broader whole-of-government effort. ARPA-H is funding a program to collect safety and efficacy data through early-phase ibogaine trials, and the National Institute on Drug Abuse (NIDA) is funding research on ibogaine as a potential treatment for opioid use disorder. Stakeholders can submit comments electronically at regulations.gov by searching for Docket No. FDA-2026-N-10429.
The regulatory push that set this in motion
The current RFI builds on a series of actions the FDA announced in late April, shortly after President Trump signed an executive order on April 18 directing HHS to accelerate access to treatments for patients with serious mental illness, including treatment-resistant and complex conditions. The order directed agencies to prioritize therapies with Breakthrough Therapy designation showing meaningful improvement over existing options, and explicitly named psychedelic therapies including ibogaine as part of the administration's approach to the nation's mental health crisis.2
Acting on that directive, the FDA announced national priority vouchers for three companies: one studying psilocybin for treatment-resistant depression, one studying psilocybin for major depressive disorder, and one studying methylone for PTSD.
The agency also allowed an early-phase clinical study of noribogaine hydrochloride, a derivative of ibogaine, to move forward following an Investigational New Drug (IND) submission from DemeRx NB. The FDA described it at the time as the first instance in which it had allowed a clinical study in the US of an ibogaine derivative. The sponsor is investigating noribogaine as a potential treatment for alcohol use disorder, a condition with high relapse rates and limited treatment options.
"These medications have the potential to address the nation's mental health crisis, including conditions like treatment-resistant depression, alcoholism and other serious mental health and substance abuse conditions," said then-FDA Commissioner Marty Makary, MD, MPH, at the time. "As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence. We owe it to our nation's veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency."
In July, the
References
- FDA Seeks Public Input to Support Ibogaine Research. FDA. October 5, 2026.
https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research - FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order. FDA. April 24, 2026.
https://www.fda.gov/news-events/press-announcements/fda-accelerates-action-treatments-serious-mental-illness-following-executive-order
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