FDA seeks public input on ibogaine trial design as federal psychedelic-medicine push accelerates

The Food and Drug Administration on Monday opened a formal public comment process on how clinical trials of ibogaine, a potent psychedelic compound derived from a West African shrub, should be designed, the agency's most concrete step yet in a year-long push by the Trump administration to accelerate research into psychedelic treatments for addiction and mental illness.

In a request for information published October 5, the FDA asked researchers, drug developers, physicians and the public to weigh in on four areas of early-stage trial design: who should be eligible to participate, how doses should be chosen and escalated, what safety monitoring is required, and what ethical safeguards should govern informed consent and independent oversight. The agency specifically flagged proposals for starting doses that do not exceed 10 milligrams per kilogram of body weight, administered in small, sequential dose-ascending groups.

"Patients facing serious conditions that have not responded to existing treatments deserve rigorous scientific investigation of promising new approaches," said Michael Davis, director of the FDA's Center for Drug Evaluation and Research, in the announcement. "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."

A fast-moving federal push

The request for information is the latest in a string of federal actions since President Trump signed an executive order in April titled Accelerating Medical Treatments for Serious Mental Illness, which directed the FDA, the Drug Enforcement Administration and other agencies to speed research into psychedelic compounds, ibogaine chief among them. The order committed $50 million through the Advanced Research Projects Agency for Health to match state funding for psychedelic studies, and it directed the FDA to consider priority review vouchers for qualifying treatments. It did not reschedule ibogaine, which remains a Schedule I controlled substance with no approved medical use in the United States, and it did not lower the evidence FDA reviewers require before approving any drug.

Since the order, the FDA says it finalized industry guidance in July on designing psychedelic drug studies and has allowed an early-stage trial of noribogaine hydrochloride, a derivative of ibogaine, to proceed as a potential treatment for alcohol use disorder. The Department of Health and Human Services, through ARPA-H and the National Institute on Drug Abuse, is now funding research focused on two patient groups: adults with opioid use disorder and adults with post-traumatic stress disorder.

Texas moved first among the states. Gov. Greg Abbott signed Senate Bill 2308 in June 2025, committing $50 million in state funds, intended to be matched by private investment, toward FDA-sanctioned ibogaine trials for opioid use disorder, PTSD, anxiety, depression and traumatic brain injury, with particular attention to veterans. Texas has more veterans than any other state, and the law includes a revenue-sharing provision that would return a share of any eventual drug royalties to the state treasury.

Serious safety questions remain unresolved

The enthusiasm from the White House and Texas lawmakers sits alongside a body of published research describing ibogaine as cardiotoxic. The compound blocks a potassium channel in heart tissue known as hERG, prolonging the heart's electrical recovery time, a measurement called the QT interval. A review of ibogaine's cardiac effects published in the journal Molecules found that in one observational group, ibogaine lengthened the QT interval by an average of 95 milliseconds, with half of subjects crossing a threshold widely considered dangerous for triggering a potentially fatal arrhythmia called torsades de pointes. The same literature documents dozens of deaths associated with ibogaine use, the large majority in unregulated settings abroad, such as Mexico, where people with addictions have long traveled for treatment unavailable legally in the United States, without cardiac monitoring or trained emergency staff present.

That risk profile is why the FDA's request for information leans heavily on monitoring: it asks specifically for input on cardiac and neurologic adverse-event surveillance and on what independent safety oversight a trial sponsor should be required to put in place. Physician groups that have testified against loosening access to ibogaine outside of supervised research have pointed to the same hazard, arguing that any legitimate use requires electrocardiogram screening, continuous monitoring and a hospital-level setting, not the informal clinics that have sprung up to serve Americans seeking the drug overseas.

Who stands to be affected

The populations the government is prioritizing for research funding, people with opioid use disorder and people with post-traumatic stress disorder, include large numbers of veterans, a constituency that figured prominently in the political case for Texas's investment and in the April executive order. Addiction medicine specialists have generally welcomed more rigorous federal study of a compound already sought out informally by thousands of Americans, but many have cautioned that the existing evidence base rests mostly on case reports and small observational studies rather than the randomized, controlled trials the FDA would ultimately require for approval.

No drug containing ibogaine or its derivatives is currently approved for any use in the United States, and Monday's request for information does not change that. It also does not create any new legal pathway for patients to obtain ibogaine outside of a registered clinical trial.

What happens next

The public has 45 days from the request's publication in the Federal Register to submit comments through the docket, numbered FDA-2026-N-10429, with the window closing November 20. The agency said late submissions will not be considered. Input gathered through the process is expected to shape draft trial protocols that the FDA weighs as it reviews new investigational drug applications for ibogaine-based treatments, including any filed by Texas's state-backed research program, which has said it intends to run its own trials after failing to secure a pharmaceutical partner.

None of the steps taken so far, the executive order, the state funding, the finalized guidance or Monday's request for comment, amounts to approval of ibogaine for any medical use. Any drug that eventually emerges from this research would still need to clear the FDA's standard review process, including large-scale trials demonstrating that its benefits for conditions such as opioid use disorder and PTSD outweigh the cardiac risks regulators and outside physicians have both flagged.