Metadoxine

Generic Name: Metadoxine

Drug Type: Small Molecule

Chemical Formula: C_₁₃H_₁₈N_₂O_₆

CAS Number: 74536-44-0

Unique Ingredient Identifier: EJQ7M98H5J

Overview

No overview information available.

Indication

主要用于急性慢性酒精中毒及酒精性肝病。

Associated Conditions

Intoxication Alcohol

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Trial to Evaluate the Efficacy of Metadoxine as a Therapy for Patients With Non-alcoholic Steatohepatitis	2015/09/04	NCT02541045	Phase 3	Withdrawn	Hospital General de Mexico
The MEASURE Study - A Phase 3 Study of MDX 1400 mg Daily Compared With Placebo in Adults With ADHD	2015/06/23	NCT02477748	Phase 3	Terminated	Alcobra Ltd.
Safety and Tolerability Study of Metadoxine Extended Release (MDX) (Previously Known as MG01CI) in PI-ADHD Adolescent Subjects	2014/07/15	NCT02189772	Phase 2	Completed	Alcobra Ltd.
Effect of Metadoxine on Oxidative Stress in Non-alcoholic Hepatic Steatosis	2014/01/31	NCT02051842	Phase 4	UNKNOWN	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Efficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis	2013/12/24	NCT02019056	Phase 2	Completed	PharmaKing
A Phase 1 Study to Assess Pharmacokinetics of Metadoxine (MG01CI) 1400 mg, Administered to Healthy Volunteers	2013/09/04	NCT01933997	Phase 1	Completed	Alcobra Ltd.
Study Comparing Two Doses of MG01CI and Placebo in Adults With Predominantly Inattentive Attention Deficit Hyperactivity Disorder	2012/09/14	NCT01685281	Phase 2	Completed	Alcobra Ltd.
A Novel Pharmacotherapy for Alcoholism and Alcohol Liver Disease	2012/01/05	NCT01504295	Phase 2	Completed	Brown University
Clinical Efficacy & Safety, of Metadoxine (MG01CI) Extended Release in Attention-Deficit Hyperactivity Disorder (ADHD)	2010/11/18	NCT01243242	Phase 2	Completed	Alcobra Ltd.
Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects	2009/10/14	NCT00995085	Phase 1	Completed	Alcobra Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Metadoxine Capsules	浙江震元制药有限公司	国药准字H20052458	化学药品	胶囊剂	6/12/2020
Metadoxine Injection	武陟维尔康生化制药有限公司	国药准字H20140094	化学药品	注射剂	1/27/2021
Metadoxine Injection	浙江震元制药有限公司	国药准字H20130022	化学药品	注射剂	1/13/2023
Metadoxine Oral Solution	扬子江药业集团有限公司	国药准字H20143350	化学药品	口服溶液剂	7/29/2019
Metadoxine Tablets	浙江震元制药有限公司	国药准字H20080068	化学药品	片剂	1/5/2023
Metadoxine Tablets	山东齐都药业有限公司	国药准字H20060280	化学药品	片剂	11/28/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

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