BIONEWS
The FDA is soliciting public comment on cardiac monitoring, dosing limits, and trial stopping rules for the first federal ibogaine research program, a $50M initiative born from an April executive order.
The federal government is moving to run its first clinical trials of ibogaine — a psychedelic compound long classified as illegal — for opioid addiction and PTSD, opening a public comment period on safety rules as the $50 million research program gets underway.
The FDA on Monday opened a public docket (FDA-2026-N-10429) seeking feedback on key trial design elements: dose selection and escalation, safety monitoring for cardiac and neurologic adverse events, patient eligibility criteria, study-stopping rules, and safety oversight, with comments due November 20, 2026.[^1][^2] The agency has proposed a starting dose not exceeding 10 mg/kg.[^2]
The initiative follows an April executive order by President Donald Trump that dedicated $50 million in funding through the Advanced Research Projects Agency for Health (ARPA-H) to federal ibogaine research, authorized FDA priority review vouchers, and expanded right-to-try pathways for the compound.[^3] The Department of Health and Human Services is funding early-stage trials through ARPA-H and the National Institute on Drug Abuse (NIDA).[^1]
"This is the most important regulatory signal ibogaine has received in decades," said Tom Feegel, CEO of Beond, a Mexico-based ibogaine treatment provider.[^1]
Ibogaine, a compound found in the roots of the African shrub iboga, is classified as a Schedule I controlled substance under U.S. law — the same category as heroin and peyote. The FDA has previously warned that the drug carries severe health risks, including life-threatening irregular heart rhythms and potential brain toxicity.[^1]
"Cardiac safety is not a footnote... it is the central challenge researchers have to solve before this treatment can responsibly reach the people who need it," said Betty Aldworth, co-executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS).[^1]
The first federally supported trials are expected to enroll adults with opioid use disorder (OUD) and adults with PTSD.[^2] HHS is prioritizing both populations under the ARPA-H program.[^2]
The docket is open at regulations.gov (Docket No. FDA-2026-N-10429).[^2]
[^1]: Reuters, "US advances first government-funded trials of psychedelic drug ibogaine," October 5, 2026. https://www.reuters.com/legal/litigation/us-advances-first-government-funded-trials-psychedelic-drug-ibogaine-2026-10-05/
[^2]: FDA press release, "FDA Seeks Public Input to Support Ibogaine Research," October 2026. https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research
[^3]: White House fact sheet, "President Donald J. Trump is Accelerating Medical Treatments for Serious Mental Illness," April 2026. https://www.whitehouse.gov/fact-sheets/2026/04/fact-sheet-president-donald-j-trump-is-accelerating-medical-treatments-for-serious-mental-illness/