The FDA Just Cleared Its First-Ever US Trial of an Ibogaine Derivative
Two days after the FDA opened its public comment docket on ibogaine trial design — which we covered here — Chemical & Engineering News flagged a separate, quieter milestone: the FDA has cleared an IND application for noribogaine hydrochloride, an ibogaine derivative designed to retain its potential as an addiction treatment without the psychoactive effects, sponsored by DemeRx NB for a Phase 1 alcohol use disorder trial. It's the first time the agency has allowed any US clinical study of an ibogaine-related compound — notable given DemeRx's own ibogaine HCl program, covered in our patent deep dive, stalled after a cardiac signal in a Phase 1 participant.
The momentum isn't just federal. C&EN notes Arizona, California, and Indiana have passed legislation supporting ibogaine research, and Texas committed $50 million to study the drug last year after a campaign led by former governor Rick Perry. "This is the most important regulatory signal ibogaine has received in decades," Tom Feegel, CEO of the Mexico-based ibogaine clinic Beond, told Reuters. Ibogaine itself remains Schedule I, with "no currently accepted medical use" in the DEA's own classification — a derivative clearing even a Phase 1 bar doesn't change that, and FDA drug center director Michael Davis was explicit about why the caution stays high: "there are important scientific questions as well as serious safety concerns." Ibogaine's cardiac risk, not its hallucinogenic effects, is still the thing standing between any of this and a patient.