Ibogaine's active metabolite, noribogaine, was cleared by the Food and Drug Administration in late April for first-in-human testing in the United States, DemeRx CEO and founder Deborah Mash announced on June 15. The company plans to launch a Phase 2 trial in alcohol use disorder early next year.
This FDA approval follows increased federal support for psychedelic therapies, including an executive order signed by President Donald Trump directing regulators to accelerate development of such treatments. Other companies developing psychedelics—Compass Pathways, Usona Institute, and Transcend Therapeutics—have received Commissioner’s National Priority Vouchers that shorten review periods for late-stage drugs. However, neither ibogaine nor its derivatives have previously been tested in humans in the U.S., despite their historical use by indigenous people in West Central Africa.
Ibogaine has drawn attention from both political figures and media personalities due to its potential applications for substance use disorders and mental health conditions such as PTSD and traumatic brain injury. Podcaster Joe Rogan said he advocated directly with Trump about ibogaine’s benefits after learning about it through contacts involved with the Texas Ibogaine Initiative.
Despite growing interest, experts warn of significant risks associated with ibogaine's toxicity profile—particularly cardiotoxicity leading to potentially fatal heart arrhythmias—and note that as of 2022 there were 33 deaths reported after ibogaine use. Patrick Trucchio, biotech analyst at H.C. Wainwright, said, “It’s very risky. There’s a reason why none of the drug companies that we cover have brought something like it forward, and it’s because of the safety concerns.”
DemeRx is focusing on noribogaine because it reportedly lacks psychoactive effects while retaining therapeutic potential; a recent Phase 1 study conducted in the UK found noribogaine safe and well-tolerated among healthy volunteers but did show some dose-related QTc interval increases—a marker for cardiac risk—that were not considered clinically relevant, according to DemeRx.
While some researchers remain skeptical about whether noribogaine is safer than ibogaine itself—with analyses suggesting persistent cardiac risks—Mash remains optimistic: “Noribogaine is simple. Noribogaine is not a hallucinogen... It’s very safe [and] well tolerated.” Nevertheless, Trucchio cautioned that investigational new drug clearance does not guarantee eventual approval: “They’re not lowering the evidentiary bar,” he said regarding FDA requirements for rigorous clinical trials.
