Transforming treatment for addiction & neuropsychiatric disorders.
DMX-1001 — the science of restoring brain health.
DMX-1001 is oral noribogaine, the active metabolite of ibogaine — a non-hallucinogenic neuroplastogen engineered to treat the brain biology of addiction. Our lead indication is alcohol use disorder (AUD), with platform potential across substance use and other CNS conditions.
Addiction is a chronic, relapsing brain disease.
Alcohol use disorder is not a behavioral failure — it is dysregulation of the brain's reward, stress, and executive-control circuitry. Chronic alcohol exposure rewires synaptic connections, blunts dopaminergic signaling, and amplifies stress-driven craving. Conventional treatments manage symptoms; the underlying neurobiology remains unchanged, which is why relapse is the norm rather than the exception.
Today only three medicines — disulfiram, naltrexone, and acamprosate — are FDA-approved for AUD. Fewer than 2% of adults with the disorder receive any of them, and even among those who do, NIAAA itself acknowledges that "many individuals show only limited or no response." The treatment gap is one of the largest in modern medicine.
In any given year, less than 10 percent of individuals diagnosed with alcohol use disorder receive treatment, and many of them do not receive the type of care that best fits their needs.
Noribogaine — ibogaine's active metabolite, without the liabilities.
Ibogaine, an indole alkaloid from the West African shrub Tabernanthe iboga, has shown remarkable anti-addictive properties for decades — but its psychoactive intensity, long duration, and cardiac risks have kept it out of the clinic. Inside the body, ibogaine is rapidly converted to noribogaine, and a growing body of evidence suggests noribogaine carries much of the therapeutic activity while shedding the hallucinogenic profile.
DMX-1001 is a proprietary oral formulation of noribogaine — a new chemical entity engineered for controlled, repeatable dosing in a standard clinical setting. No retreat. No 24-hour psychedelic experience. A medicine that can be taken, titrated, and integrated into care.
Therapeutic activity, isolated
Noribogaine is the principal metabolite responsible for the prolonged anti-addictive effects observed with ibogaine — without the acute hallucinogenic experience of the parent compound.
Oral, controlled, repeatable
DMX-1001 is formulated for oral administration with controlled pharmacokinetics — a fit for outpatient AUD treatment and a conventional regulatory path.
Targeted neuroplasticity in the brain's addiction circuitry.
A neuroplastogen is a compound that promotes structural and functional remodeling of neurons — the regrowth of dendrites, strengthening of synaptic connections, and rebalancing of circuits that addiction has disrupted. Unlike acute psychedelics that drive a single, intense experience, noribogaine's neuroplastic effects appear durable and integrative.
- Dopaminergic rebalancing. Noribogaine modulates dopamine signaling in reward circuits — easing the drive that propels relapse without producing reward of its own.
- Glutamatergic plasticity. Preclinical work supports activity at NMDA and related glutamate systems — pathways central to learning, memory, and the consolidation of new, healthier patterns.
- Stress-circuit modulation. Effects on opioid and serotonergic systems support reduced craving and stress reactivity during recovery.
- Disease-modifying intent. The aim is not symptom suppression but structural restoration — treating addiction at the level of brain biology.
Phase 1a complete. Phase 1b active. Phase 2 planned.
DMX-1001 has cleared the first major safety bar. The Phase 1a multiple-ascending-dose (MAD) trial in healthy volunteers established a favorable safety and tolerability profile, with pharmacokinetics supporting the planned dosing approach. Phase 1b is enrolling now, refining PK/PD ahead of a Phase 2 proof-of-concept study in AUD.
Multiple Ascending Dose (MAD)
Safety, tolerability, and pharmacokinetics confirmed in healthy volunteers. No new safety signals; cardiac monitoring within expected parameters under board-level cardiology oversight.
PK / PD in healthy volunteers
Active program characterizing pharmacokinetics and pharmacodynamics — the bridge to a Phase 2 study in alcohol use disorder.
Composition, methods, formulations, combinations — protected.
DemeRx's intellectual property estate covers the molecule, its uses, formulation approaches, and combination strategies. Independent validation comes from the U.S. National Institutes of Health, which awarded a $1.7M non-dilutive grant supporting the program.
Composition · methods · formulations · combinations
Multiple granted patents protect DMX-1001 across the dimensions that matter to a commercial program — the molecule itself, its therapeutic uses, the oral formulation, and combination approaches.
NIH grant — $1.7M non-dilutive
A National Institutes of Health award supporting the DMX-1001 program — independent scientific validation of the approach.
The ibogaine class's reputation, addressed head-on.
Investors and clinicians familiar with the ibogaine class have one question first: cardiac safety. The historical concern stems from unsupervised ibogaine use, where QT prolongation has been documented. DMX-1001 is designed and developed around this question. The Phase 1a MAD trial confirmed a favorable safety and tolerability profile, and cardiology oversight is led at board level by Pascal Goldschmidt, MD, former Dean of the University of Miami Miller School of Medicine and a recognized authority in cardiovascular medicine.
Cardiac monitoring is a built-in feature of the clinical program — not an afterthought.
AUD first. Then the rest of the brain.
Addiction shares biology across substances. The same circuits implicated in alcohol use disorder are central to opioid and stimulant use disorders, and neuroplastic mechanisms have implications across mood and other CNS conditions. DMX-1001 is positioned as a platform — AUD is the entry indication; opioid use disorder, cocaine use disorder, and adjacent CNS programs sit in the pipeline.
- Alcohol use disorder (AUD) — lead indication; Phase 2 next.
- Opioid use disorder (OUD) — pipeline expansion supported by ibogaine-class anti-addictive evidence.
- Cocaine use disorder — preclinical exploration of the same neuroplastic mechanism.
- Mood and adjacent CNS — neuroplasticity as a class of mechanism with implications beyond addiction.
Selected peer-reviewed publications anchoring noribogaine pharmacology, the foundation of DMX-1001, and the mechanism behind neuroplastogen-driven recovery. Full bibliography available on request.
- Mash, D.C. (2023). Ibogaine — A legacy within the current renaissance of psychedelic therapy. Pharmacological Research, 190, 106620. (IUPHAR invited review.)
- Mash, D.C., Ameer, B., Prou, D., Howes, J.F., Maillet, E.L. (2016). Oral noribogaine shows high brain uptake and anti-withdrawal effects not associated with place preference in rodents. Journal of Psychopharmacology, 30(7), 688–697. (Foundational DMX-1001 oral noribogaine paper.)
- Maillet, E.L., Milon, N., Heghinian, M.D., Fishback, J., Schurer, S.C., Garamszegi, N., Mash, D.C. (2015). Noribogaine is a G-protein biased κ-opioid receptor agonist. Neuropharmacology, 99, 675–688.
- Mash, D.C., Duque, L., Page, B., Ferdinand, K.A. (2018). Ibogaine detoxification transitions opioid and cocaine abusers between dependence and abstinence: clinical observations and treatment outcomes. Frontiers in Pharmacology.
- Mash, D.C. (2018). Breaking the cycle of opioid use disorder with ibogaine. American Journal of Drug and Alcohol Abuse, 44(1), 1–3.
- Mash, D.C., Kovera, C.A., Pablo, J., Tyndale, F.R., Ervin, F.D., Williams, I.C., Singleton, E.G., Mayor, M. (2000). Ibogaine: complex pharmacokinetics, concerns for safety, and preliminary efficacy measures. Annals of the New York Academy of Sciences, 914, 394–401.
A Phase 2-ready program to change how addiction is treated.
DemeRx is advancing DMX-1001 toward Phase 2 proof-of-concept in AUD, with platform potential across substance use and CNS. Investors and partners can learn more about the program, the team, and the raise.