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Metadoxine extended release
Metadoxine is a combination of pyridoxine (vitamin B6) and L-2-aminoethanol that enhances acetaldehyde metabolism and reduces its toxic accumulation in alcohol-related disorders.
Metadoxine is a combination of pyridoxine (vitamin B6) and L-2-aminoadipic acid that enhances acetaldehyde metabolism and reduces its toxic accumulation in alcohol-related disorders. Used for Alcohol use disorder with hepatic impairment, Alcoholic liver disease.
At a glance
| Generic name | Metadoxine extended release |
|---|---|
| Also known as | MDX, Metadoxil, Abrixone, Metadoxine, Metadoxil, Abrixone, Metadoxil |
| Sponsor | Alcobra Ltd. |
| Drug class | Vitamin B6 derivative / Acetaldehyde metabolism enhancer |
| Modality | Small molecule |
| Therapeutic area | Hepatology / Addiction Medicine |
| Phase | FDA-approved |
Mechanism of action
Metadoxine acts as a cofactor in the conversion of acetaldehyde to acetate, accelerating the detoxification pathway and reducing acetaldehyde-induced oxidative stress. It also enhances hepatic glutathione levels and reduces lipid peroxidation, providing cytoprotective effects in alcohol-related liver disease and acute alcohol intoxication.
Approved indications
- Acute alcohol intoxication
- Alcohol-related liver disease
- Hangover symptoms
Common side effects
- Nausea
- Headache
- Dizziness
- Gastrointestinal disturbance
Key clinical trials
- Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects (PHASE1)
- A 6-week, Study of MG01CI Low Dose and High Dose Compared With Placebo in Adults and Adolescents With Fragile X Syndrome (PHASE2)
- Safety and Tolerability Study of Metadoxine Extended Release (MDX) (Previously Known as MG01CI) in PI-ADHD Adolescent Subjects (PHASE2)
- Study Comparing Two Doses of MG01CI and Placebo in Adults With Predominantly Inattentive Attention Deficit Hyperactivity Disorder (PHASE2)
- Clinical Efficacy & Safety, of Metadoxine (MG01CI) Extended Release in Attention-Deficit Hyperactivity Disorder (ADHD) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Metadoxine extended release CI brief — competitive landscape report
- Metadoxine extended release updates RSS · CI watch RSS
- Alcobra Ltd. portfolio CI