Delving into the Latest Updates on Metadoxine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

MDX, Metadoxine sustained-release, Pyridoxine pidolate

+ [5]

Target

5-HT2B receptor

Mechanism

5-HT2B receptor antagonists(Serotonin 2b (5-HT2b) receptor antagonists)

Therapeutic Areas

Digestive System Disorders

Active Indication

Hepatitis, Alcoholic

Inactive Indication

Attention Deficit DisorderAttention Deficit Disorder With HyperactivityFatty Liver, Alcoholic+ [1]

Originator Organization

Zhejiang Zhenyuan Pharmaceutical Co., Ltd.

Active Organization

Zhejiang Zhenyuan Pharmaceutical Co., Ltd.

Inactive Organization

Alcobra Ltd.

Pharma King Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

CN (01 Dec 2005),

Hepatitis, Alcoholic

RegulationOrphan Drug (US)

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Structure

Molecular FormulaC13H18N2O6

InChIKeyRYKKQQUKJJGFMN-HVDRVSQOSA-N

CAS Registry74536-44-0

View All Structures (2)

CLINICAL TRIAL, DOUBLE-BLIND, RANDOMIZED, COMPARED WITH PLACEBO TO EVALUATE THE EFFICACY AND SAFETY OF HYDROXOCOBALAMIN (VITAMIN B12) 10,000 MCG + THIAMINE HYDROCHLORIDE (VITAMIN B1) 100 MG + PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) 50 MG (BEDOYECTA® TRI), COMBINATED WITH STANDARD OF CARE TREATMENT IN PATIENTS WITH CHRONIC LOW BACK PAIN.

Start Date02 Aug 2021

Sponsor / Collaborator-

NCT02051842 / Unknown statusPhase 4IIT

Effect of Metadoxine on Oxidative Stress in Non-alcoholic Fatty Liver Disease Prediabetic Mexican Patients

Oxidative stress is produced by imbalance between reactive oxygen species and antioxidant systems. This state is frequently associated with chronic diseases like obesity, insulin resistance, metabolic syndrome and hepatic steatosis. In the liver, the oxidative stress may trigger the progression of fatty liver disease, from triglyceride accumulation to inflammation, cirrhosis and hepatocellular carcinoma. Thus, the attenuation of oxidative stress, could be an important therapeutic target to lessen the severity of the disease. Until now, there is not a medical treatment to cure non-alcoholic fatty liver disease, but therapies aimed at reducing oxidative stress have been proposed. Metadoxine, an ionic complex of pyridoxine-pyrrolidone molecule, acts as a synthetic antioxidant, forming traps that can reduce free radicals; likewise, metadoxine has a proven capacity to reduce fat liver in alcoholic hepatitis. Finally, in fact that alcoholic and non-alcoholic liver diseases share molecular mechanisms in the generation of oxidative stress, the investigators propose metadoxine as a posssible modifier of the oxidative stress in non-alcoholic liver disease, prediabetic patients.

Start Date01 Jan 2016

Sponsor / Collaborator

Instituto Nacional de Ciencias Medicas y Nutricion

NCT02541045 / WithdrawnPhase 3IIT

Clinical Trial to Evaluate the Efficacy of Metadoxine as a Therapy for Patients With Non-alcoholic Steatohepatitis

The aim of this study is to evaluate the efficacy of metadoxine as a therapy for patients with biopsy-proven non-alcoholic steatohepatitis.

Start Date01 Aug 2015

Sponsor / Collaborator

Hospital General de México

100 Clinical Results associated with Metadoxine

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100 Translational Medicine associated with Metadoxine

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100 Patents (Medical) associated with Metadoxine

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123

Literatures (Medical) associated with Metadoxine

31 Dec 2024·Journal of Medical Economics

Detection of genomic alterations in liquid biopsies from patients with non-small cell lung cancer using FoundationOne Liquid CDx: a cost-effectiveness analysis

Article

Author: Garrido, Pilar ; Carcedo, David ; Ortega, Ana L. ; Azkona, Eider ; Arriola, Edurne ; Álvarez, Rosa ; Bernabé, Reyes ; Córcoles, Fernando ; Lavara, Jesús ; Nadal, Ernest ; Crespo, María ; García-Campelo, Rosario ; Isla, Dolores ; Arnal, María ; Azkarate, Aitor

OBJECTIVELiquid biopsy (LB) is a non-invasive technique to detect genetic alterations by next-generation sequencing (NGS) when tissue biopsy is not available. This study aims to estimate in the Spanish setting, the cost-effectiveness of using FoundationOne Liquid CDx (F1L CDx), a novel blood-derived LB test based on NGS, versus non-molecular diagnosis (non-mDx) in patients with advanced non-small cell lung cancer (NSCLC) in whom tissue sampling is not feasible.METHODSA joint model was developed combining a decision-tree with partitioned survival models to calculate the costs and health outcomes over a lifetime horizon, comparing F1L CDx in LB versus non-mDx. Only direct costs (expressed in € of 2023) were included and a 3% discount rate for future costs and effects was considered. Health outcomes were expressed in Life Years (LYs) and Quality-Adjusted Life Years (QALYs). Utilities and treatment efficacy were obtained from the literature. An expert panel of 11 Spanish oncologists determined the treatment allocation and validated all model inputs and assumptions. Several sensitivity analyses were performed to assess the robustness of the results.RESULTSIn a hypothetical cohort of 1,000 patients, LB using F1L CDx would detect 386 alterations, so those patients could be treated with targeted therapies or enrolled in clinical trials. Cost-effectiveness results showed that F1L CDx provides greater effectiveness than non-mDx (+383.95 LYs and +305.94 QALYs), with an additional cost of €2,898,308. The incremental cost-utility ratio was €9,473/QALY gained. The probabilistic sensitivity analysis confirmed the robustness of the cost-effectiveness results.LIMITATIONSVarious limitations inherent to cost-effectiveness analyses were described.CONCLUSIONLB with F1L CDx test is a cost-effective strategy in Spain for patients with advanced NSCLC without tissue sample available for molecular diagnosis, improving the personalized treatment of these patients.

01 Nov 2024·Clinics in Liver Disease

Emerging Pharmacologic Treatments for Alcohol-Associated Hepatitis

Review

Author: Morgan, Timothy R ; Morgan, Timothy R.

Several treatments have shown efficacy in preliminary alcohol-associated hepatitis trials. Interleukin-22 improved Model of End-stage Liver Disease score and aminotransferases in a phase II trial. The endogenous cholesterol derivative, larsucosterol, improved outcomes in a multi-center United States or European phase II trial. The antioxidants N-acetylcysteine and metadoxine improved survival in large trials. Trials from India report improved survival with granulocyte-colony stimulating factor, as well as improved outcome among patients receiving fecal microbiota transfer. Translational studies suggest that phage treatment of cytolytic Enterococcus faecalis may reduce liver injury.

28 Oct 2024·Current Protein & Peptide Science

Insights into the Binding of Metadoxine with Bovine Serum Albumin: A Multi-Spectroscopic Investigation Combined with Molecular Docking

Article

Author: Pathania, Apoorva ; Pathania, Anu Radha ; Kour, Harman Deep

Background:Metadoxine, also known as pyruvate dehydrogenase activator, is a small molecule drug that has been used in the treatment of various medical conditions. Bovine serum albumin is a commonly studied protein that serves as a plasmatic for understanding protein-drug interactions due to its abundance.Objective:This research suggests that metadoxine can bind to bovine serum albumin with moderate affinity, leading to an alteration in the secondary structure of the protein, which may also influence the protein's stability and function, which could provide a comprehensive understanding of the interaction at a molecular level. In this study, a variety of methodologies wereused to determine various thermodynamic parameters.Methods:The study uses UV-visible, Fluorescence, Fourier-transform infrared, Circular dichroism spectroscopy, and Molecular docking to analyze the interaction between bovine serum albumin and metadoxine, providing thermodynamic parameters for understanding the protein structure and its bindingResult:The binding of metadoxine with bovine serum albumin, causes a hyperchromic shift. In fluorescence spectroscopy, the value of the Stern Volmer increases constantly with an increase in temperature, suggesting a stronger interaction between the Metadoxine and the Bovine serum albumin, leading to dynamic quenching. Additionally, Fourier-transform infrared and circular dichroism indicated a reduction in the secondary structure of Bovine serum albumin.Conclusion:The interactions between metadoxine and bovine serum albumin, cause hyperchromic shift revealed by UV-visible spectroscopy, whereas in Fluorescence spectroscopy, the value of the Stern Volmer constant increases with an increase in temperature, suggesting a stronger interaction between the MD and the BSA, leading to dynamic quenching. Additionally, Fourier-transform infrared and circular dichroism spectroscopy indicated a reduction in the secondary structure of the protein, as evidenced by the shifting of the amide II band and leading to a slight decrease in the αhelix content. The molecular docking shows that metadoxine was docked in the subdomain IIA binding pocket of BSA.

100 Deals associated with Metadoxine

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External Link

KEGG	Wiki	ATC	Drug Bank
D08186	Metadoxine	A05	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis, Alcoholic	CN	Zhejiang Zhenyuan Pharmaceutical Co., Ltd.	01 Dec 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	Phase 1	US	Alcobra Ltd.	01 Jun 2015
Attention Deficit Disorder With Hyperactivity	Phase 1	IL	Alcobra Ltd.	01 Jun 2015
Fragile X Syndrome	Preclinical	IL	Alcobra Ltd.	01 Jun 2014
Fragile X Syndrome	Preclinical	US	Alcobra Ltd.	01 Jun 2014
Attention Deficit Disorder	Preclinical	IL	Alcobra Ltd.	01 Feb 2011
Fatty Liver, Alcoholic	Preclinical	KR	Pharma King Co., Ltd.	01 Nov 2010
Hepatitis, Alcoholic	Preclinical	KR	Pharma King Co., Ltd.	01 Nov 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02059642 (CTgov)	Phase 2/3	Attention Deficit Disorder With Hyperactivity	300	placebo (Placebo)	dmonaindru(exhihouetw) = rusgbzbfgg jluiklolil (ujhtdgckbi, zxpopbkmmr - vpchkkdhjq) View more	-	28 Mar 2017
				MG01CI (1400 mg) (MG01CI (1400 mg))	dmonaindru(exhihouetw) = qzkreisvtj jluiklolil (ujhtdgckbi, qrhjzekuqy - pqfwretpbb) View more
NCT02477748 (MEASURE, GlobeNewswire) Manual	Phase 3	Attention Deficit Disorder With Hyperactivity	283	Metadoxine Extended Release	(olgdjgbwfk) = In this trial, MDX did not meet the primary endpoint, which was a statistically significant change from baseline in investigator ratings on the Conners Adult ADHD Rating Scale (CAARS) compared to placebo. iwwmkwirxg (fbpofniuel )	Negative	17 Jan 2017
NCT02126995 (GlobeNewswire) Manual	Phase 2	Fragile X Syndrome	62	MG01CI	mqmluykviu(vqupfjvxdw): P-Value = 0.21 View more	Negative	24 Jun 2015
				Placebo
NCT01685281 (Pubmed \| Postgrad Med)	Phase 2	Attention Deficit Disorder With Hyperactivity	36	Metadoxine extended release 1400 mg	(jfgcchnbwd) = fjxqijafpt usobcflpax (mmoddlgsuf )	Positive	01 Sep 2014
				Placebo	(jfgcchnbwd) = jgtngcpror usobcflpax (mmoddlgsuf )
NCT01243242 (CTgov)	Phase 2	Attention Deficit Disorder	120	Metadoxine (MG01CI)	mjrrprrucd(rcdbfykbpg) = xldysdbuln optpmcyorx (gvvegaqzsr, mamsvfmkcr - oimztidddf) View more	-	18 Apr 2012
NCT00995085 (CTgov)	Phase 1	Attention Deficit Disorder With Hyperactivity	43	Extended Release Metadoxine	(duupyovrxf) = wfnzpotyzr nlvdvjkcfz (rocmwtbitz, xgspfcoqwr - aqdgpzfgui) View more	-	06 Jul 2011