DemeRx Announces FDA Acceptance of IND Application for DMX-1001 (Oral Noribogaine) to Treat Alcohol Use Disorder

DMX-1001 (oral noribogaine) for alcohol use disorder (AUD) moves forward after the FDA accepted DemeRx's IND application. DemeRx says the drug is a neuroplastogen that combines neuroplasticity and polypharmacology. Noribogaine, a long-acting metabolite of ibogaine, is intended to persist longer in the body than ibogaine and drive long-term neuroplastic changes that may help repair neural circuits affected by chronic substance abuse. The company reports completing a multiple ascending dose study in healthy volunteers, with results supporting safety, tolerability, and pharmacokinetics for advancement. After a planned alcohol interaction trial, DemeRx anticipates starting Phase 2 trials in people with AUD in 2027.