DemeRx

Phase 2 trial in AUD patients planned for 2026

Why it matters: First efficacy trial of noribogaine in AUD patients. If DMX-1001 demonstrates reduced drinking and/or sustained abstinence via GDNF-mediated neuroplasticity, it would be a first-in-class neuroplastogen for addiction — mechanistically distinct from all current AUD treatments (naltrexone, acamprosate, disulfiram).

Watch next: Phase 2 protocol disclosure; first patient enrolled; interim efficacy data

Actual: Jun 1, 2025

DemeRx joined Medical Psychedelics Working Group (MPWG)

Why it matters: Industry coalition membership signals engagement with regulatory and policy frameworks for psychedelic-adjacent medicines.

Actual: Oct 7, 2025

Awarded $1.7M NIH SBIR grant from NIAAA (Award #R43AA032127) to advance DMX-1001 through IND-enabling studies toward Phase 2

Why it matters: NIAAA grant validates DMX-1001's neuroplastogen mechanism for AUD. Non-dilutive NIH funding provides capital for IND-enabling and Phase 2 preparation. DMX-1001 enhances GDNF (Glial cell line-Derived Neurotrophic Factor) to repair dopaminergic neural circuits damaged by chronic heavy drinking — a repair mechanism rather than substitution therapy.

Actual: Jan 6, 2026

Successful completion of Phase 1 Multiple Ascending Dose (MAD) trial (NCT06480981): double-blind, placebo-controlled, 55 healthy volunteers, doses 20-80mg daily. Safe and well-tolerated; QT effect not clinically relevant

Why it matters: Clean Phase 1 safety profile across a wide dose range (20-80mg) is critical for an ibogaine-derived compound — cardiac QT prolongation is the primary safety concern with ibogaine itself. Noribogaine (the active metabolite of ibogaine) showing only non-clinically-relevant QT effects at therapeutic doses is a major de-risking milestone. This differentiates DMX-1001 from ibogaine and positions it for Phase 2.