DMX-1001 is an investigational new chemical entity with granted composition-of-matter and method-of-use patents, a completed Phase 1a MAD trial, and an active Phase 1b program targeting the 29 million Americans living with AUD.
Transforming treatment for addiction & neuropsychiatric disorders.
At DemeRx, we pioneer neuroplastogen medicines that restore brain health and break the cycle of addiction — advancing disease-modifying therapies across substance use disorders, mood disorders, and other CNS conditions.
Multiple Ascending Dose trial of DMX-1001 complete — favorable safety and PK profile confirmed.
FDA IND for DMX-1001 in AUD accepted April 2026 — regulatory path to Phase 2 cleared.
Active trial evaluating PK, PD, and safety of DMX-1001 in healthy volunteers.
Granted patents covering composition of matter, methods of use, combinations, and formulations protect DMX-1001.
Addiction is a chronic, relapsing disease of brain circuitry — not a failure of willpower. DMX-1001 is oral noribogaine, the active metabolite of ibogaine, engineered to deliver the neuroplastic benefit of the ibogaine class without the hallucinogenic, cardiac, or deliverability liabilities that have held it back.
Alcohol use disorder is a chronic, relapsing condition rooted in dysregulated reward and stress circuitry. Chronic exposure rewires synaptic connections, blunts dopaminergic signaling, and amplifies stress-driven craving. DMX-1001 is designed to act on the underlying neurobiology — not just the behavior.
Noribogaine targets structural neuroplasticity in the brain's addiction circuitry, promoting the rewiring associated with durable recovery — without the euphoric or addictive properties of conventional psychedelics or opioids.
DMX-1001 is an oral new chemical entity formulated for controlled, repeatable dosing — a fit for real-world AUD treatment and a conventional clinical and commercial path. Granted composition-of-matter, methods, formulations, and combinations patents protect it.
The ibogaine class carries known cardiac considerations. Phase 1a MAD confirmed a favorable safety and tolerability profile for DMX-1001, with cardiology oversight led at board level by Pascal Goldschmidt, MD, former Dean of the University of Miami Miller School of Medicine.
DMX-1001 is a platform: AUD is the lead indication, with pipeline expansion into opioid and cocaine use disorder, and adjacent CNS conditions including mood. One oral neuroplastogen, a pipeline of opportunities.
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.
~80% of patients relapse within a year. Only three medications are FDA-approved for AUD — disulfiram, naltrexone, and acamprosate — and fewer than 2% of adults with AUD receive any of them. NIAAA itself acknowledges that "many individuals show only limited or no response" to current options.
Three medicines have already cleared the FDA for AUD. The agency understands the disease, validated endpoints exist, and the regulatory framework is in place. DMX-1001 doesn't need to forge new ground — it follows a proven path with a differentiated mechanism.
A clearly defined patient population, validated efficacy endpoints, and established prescribing channels in primary care and addiction medicine — paired with an FDA actively soliciting new entrants. AUD is the most efficient first commercial indication for a neuroplastogen platform; OUD, cocaine, and adjacent CNS follow.
DemeRx is advancing DMX-1001 through a rigorous clinical development program. This section provides current program status, pipeline, press releases, and direct IR contact.
| Asset / Indication | Preclinical | Phase 1a | Phase 1b | Phase 2 | Phase 3 |
|---|---|---|---|---|---|
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DMX-1001
Alcohol Use Disorder
Oral noribogaine · NCE
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DMX-1001
Opioid Use Disorder
Oral noribogaine · NCE
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DMX-1001
Cocaine Use Disorder
Oral noribogaine · NCE
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Our corporate presentation covers program status, preclinical and clinical data, IP position, market opportunity, and team credentials. Available to qualified investors under NDA.
DemeRx is led by the scientist who pioneered noribogaine and holds its foundational patents, backed by a board that pairs drug-development and commercial experience with dedicated cardiology and psychiatry oversight.
For institutional investors and qualified purchasers: DemeRx is a private clinical-stage company. Securities information is provided only to accredited investors under applicable securities laws. Media inquiries: media@demerx.com