FDA · Wednesday, October 7, 2026
FDA asks for advice on how to test ibogaine safely in people
The File desk · Oct 7, 2026, 10:40 AM UTC
Status
Confirmed from the FDA’s press announcement, page metadata Monday, Oct. 5, 2026, 9:02 a.m. This is a request for comments, not a rule and not an approval. A later check of fda.gov from this publish environment returned a 10-byte “Not found.” The excerpts are from the desk’s morning read of the page.
Editor’s note: The Food and Drug Administration posted this on Oct. 5, and our desk was blocked from fda.gov, so Tuesday’s edition missed it. The agency is asking researchers, doctors, and the public how early human trials of ibogaine should be run. Ibogaine is a psychedelic that some patients seek out for addiction and other hard-to-treat conditions. The FDA laid out approaches it is weighing, including how to choose and raise doses, where patients should be treated, how to watch for heart and nerve problems, who can enroll, and when to stop a trial. Comments are due Nov. 20. The agency says the step follows President Trump’s April executive order, Legal instrument An executive order signed April 18, 2026. It tells the FDA and other agencies to speed research on psychedelic drugs, including ibogaine, for people whose serious mental illness has not gotten better with standard care. It also directs a path for some patients to get these drugs under the federal Right to Try law.Accelerating Medical Treatments for Serious Mental Illness
The announcement describes a request for information on the design of early-phase clinical trials of ibogaine drug products. One approach the FDA is weighing: small groups that get rising doses, starting at a dose “not exceeding 10 mg/kg,” 10 milligrams per kilogram of body weight. Docket FDA-2026-N-10429. The page says the comment period “closes Friday, November 20, 2026. Late comments will not be considered.”
Dr. Michael Davis, director of the FDA’s Center for Drug Evaluation and Research, said: “With ibogaine, there are important scientific questions as well as serious safety concerns.”
This is not a rule and not an approval. Ibogaine is not approved. The Federal Register public-inspection page for the request loaded as site boilerplate only, so this story does not quote that document’s body.
What is still unknown or disputed
- Who has asked to run ibogaine trials. The FDA page mentions an allowed early study of noribogaine but names no company in the part the desk read.
Primary sources
Every claim in this story is drawn from the documents below. If a fetch failed, that is recorded on the card.
Source 1 · fetch incomplete
FDA Seeks Public Input to Support Ibogaine Research
U.S. Food and Drug Administration · October 5, 2026
The U.S. Food and Drug Administration today 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.
https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research
Source 2
Accelerating Medical Treatments for Serious Mental Illness
The White House · April 18, 2026
It is the policy of my Administration to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America.
https://www.whitehouse.gov/presidential-actions/2026/04/accelerating-medical-treatments-for-serious-mental-illness/