Clinical boundary Schedule I in the U.S. Serious cardiac risk Not FDA-approved No dosing or referrals Schedule I · cardiac risk Not FDA-approved · no referrals

Evidence

Alcohol use disorder

LAST REVIEWED 2026-05-18 · 346 SOURCES · 0 CORRECTIONS

FDA allowed an early phase U.S. Noribogaine hydrochloride study to proceed after an IND submission in April 2026.

Confidence: ModerateSource type: Study
Evidence level
investigational
Sample sizes
Phase I details should be read from the posted protocol or registry when available.
Design quality
Phase I permission is safety-focused and does not establish efficacy.
Outcomes
Relapse, craving, safety, tolerability, pharmacokinetics, and retention need controlled data.
Limitations
Noribogaine, Ibogaine, plant Iboga, alcohol-withdrawal risk, and clinic claims are separate subjects.
Safety signals
Alcohol withdrawal, liver health, medications, QT/QTc, electrolytes, and monitoring requirements.
What is not proven
Noribogaine is not FDA-approved for alcohol use disorder.
Best next source
FDA April 24, 2026 announcement and the eventual trial registry entry.