Delving into the Latest Updates on Itopride Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Itax, Itopride, Itopride Hydrochloridc

+ [19]

Target

ACHE x D2 receptor

Action

inhibitors, antagonists

Mechanism

AChE inhibitors(Acetylcholinesterase inhibitors), D2 receptor antagonists(Dopamine D2 receptor antagonists)

Therapeutic Areas

Cardiovascular DiseasesDigestive System DisordersOther Diseases

Active Indication

Gastrointestinal DiseasesChronic gastritisHeart Failure+ [2]

Inactive Indication

Abdomen distendedDiabetes Mellitus, Insulin-Dependent, 2Dyspepsia+ [5]

Originator Organization

Viatris Pharmaceutical GK

Active Organization

AbbVie ASViatris Pharmaceutical GK

Inactive Organization

Forest Laboratories, Inc.Axcan Pharma (Australia) Pty Ltd.

Abbott Laboratories

+ [2]

Drug Highest PhaseApproved

First Approval Date

Japan (30 Jun 1995),

Chronic gastritis

Regulation-

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Structure/Sequence

Molecular FormulaC20H26N2O4

InChIKeyQQQIECGTIMUVDS-UHFFFAOYSA-N

CAS Registry122898-67-3

View All Structures (2)

主要研究目的研究空腹和餐后状态下单次口服受试制剂盐酸伊托必利片（规格：50 mg，裕松源药业有限公司生产）与参比制剂盐酸伊托必利片（商品名为力苏®，规格：50 mg，ABBOTT LABORATORIES(M) SDN.BHD持证）在健康成年受试者体内的药代动力学，比较受试制剂和参比制剂药代动力学的差异，同时计算主要药动学参数（Cmax、AUC0-t和AUC0-∞），并进行初步比较。次要研究目的评价健康受试者在空腹和餐后状态下，单次口服盐酸伊托必利片受试制剂和参比制剂后的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test preparation itopride hydrochloride tablets (specification: 50 mg, produced by Yusongyuan Pharmaceutical Co., Ltd.) and the reference preparation itopride hydrochloride tablets (trade name Lisu®, specification: 50 mg, ABBOTT LABORATORIES(M) SDN.BHD) in healthy adult subjects after a single oral administration in the fasting and fed state, to compare the differences in pharmacokinetics between the test preparation and the reference preparation, and to calculate the main pharmacokinetic parameters (Cmax, AUC0-t and AUC0-∞), and make a preliminary comparison. Secondary study objectives To evaluate the safety of the test preparation and the reference preparation of itopride hydrochloride tablets after a single oral administration in healthy subjects in the fasting and fed state.

Start Date26 Jun 2024

Sponsor / Collaborator

Yusongyuan Pharmaceutical Co. Ltd.

NCT05966025

/ Not yet recruitingPhase 2IIT

Evaluation of the Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease

Objective of this study is to determine the clinical benefits of itopride in improvement of MAFLD

Start Date28 Dec 2023

Sponsor / Collaborator

October 6 University

[+1]

100 Clinical Results associated with Itopride Hydrochloride

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100 Translational Medicine associated with Itopride Hydrochloride

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100 Patents (Medical) associated with Itopride Hydrochloride

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425

Literatures (Medical) associated with Itopride Hydrochloride

02 Jan 2025·Expert Opinion on Drug Safety

Risk of drug-induced delirium in older patients- a pharmacovigilance study of FDA adverse event reporting system database

Article

Author: Cui, Yimin ; Li, Jiayu ; Zhou, Ying ; Wan, Liyan ; Jia, Boying ; Zhou, Shuang

BACKGROUNDDrug-induced delirium is known risk factors associated with increased morbidity and mortality in older patients. The objective was to evaluate the risk of drug-related delirium in older patients based on the FDA Adverse Event Reporting System (FAERS).RESEARCH DESIGN AND METHODSDelirium reports in older patients (age ≥65) extracted from the FAERS database using Open Vigil 2.1. The reported odds ratio and the proportional reported ratio were calculated to detect the adverse reaction signal of delirium. Combined with published evidence, suspected drugs were categorized as known, possible, or new potential delirium-risk-increasing drugs.RESULTSOf the 130,885 reports (including 28,850 delirium events and 1,857 drugs) analyzed for this study, 314 positive signal drugs were detected. Positive signal drugs are mainly concentrated on the drug of nervous system, cardiovascular system , alimentary tract and metabolism and anti-infectives for systemic use. Of the positive signal drugs, 26.11% (82/314) were known delirium-risk increasing drugs, 44.90% (141/314) were possible and 28.98% (91/314) were new potential.CONCLUSIONDrug-induced delirium risk is prevalent in older patients, according to the FAERS. The risk level of drug-induced delirium should be taken into account to optimize drug therapy in clinical practice.

01 Jan 2025·Alimentary Pharmacology & Therapeutics

Clinical Trial: Treatment of Functional Dyspepsia According to Subtype Compared With Empirical Proton Pump Inhibitor

Article

Author: Mahadeva, Sanjiv ; Chuah, Kee Huat ; Loo, Qing Yuan ; Khoo, Stanley ; Hian, Wen Xuan ; Panirsheeluam, Sarala ; Jubri, Nurhidayah Binti Mohammad ; Natarajan, Vicraman ; Khoo, Xin Hui

ABSTRACTBackgroundInternational guidelines recommend contrasting initial treatment strategies for functional dyspepsia (FD).AimsTo evaluate the efficacy and safety of treatment according to subtypes, compared with empirical proton pump inhibitor (PPI), in the initial treatment of FD.MethodsWe performed a single‐blinded, randomised controlled trial of adults with FD. In the intervention group (treatment according to subtype), patients were categorised into epigastric pain syndrome (treatment esomeprazole); postprandial distress syndrome (PDS; treatment itopride) and overlap (treatment itopride, maintain, add/or switch to esomeprazole at week 4). The control group received esomeprazole only. The primary efficacy outcome was the assessment of global symptom improvement (primary end point: best two points from the 7‐point Likert scale) over 8 weeks. Secondary outcomes included assessment of the change in nine individual upper gastrointestinal symptoms, quality of life (Short‐Form Nepean Dyspepsia Index) and adverse events.ResultsWe randomised 180 patients (median age: 50; 68.7% female 56.7% PDS) 1:1 into intervention and control arms. The percentage of patients achieving the primary efficacy outcome were 74.4% and 72.2%, respectively (p = 0.74). The improvement of individual symptoms in both groups were similar. The SF‐NDI improved after treatment in both groups (p < 0.001) but there was no significant difference in the degree of change between groups. Rates of adverse events between groups were similar at week 8.ConclusionInitial treatment of FD according to subtype was not more effective than empirical PPI alone for up to 8 weeks. Further multicentre studies, with a larger sample size, are recommended to validate these findings.Trial Registration: ClinicalTrials.gov identifier: NCT04918017

01 Dec 2024·The Journal of the Association of Physicians of India

Proposed Algorithm for the Diagnosis and Management of Functional Dyspepsia in India.

Article

Author: Pratap, Nitesh ; Rai, Ramesh R ; Mohan, V G ; Shankar, Ravi B ; Zargar, Showkat A ; Goyal, Omesh

Disorders of gut-brain interaction (DGBI), formerly known as functional bowel disorders, encompass a diverse array of conditions and symptoms that may manifest in different parts of the gastrointestinal tract. Some of the most prevalent DGBIs include functional dyspepsia, irritable bowel syndrome, functional constipation, functional diarrhea, and functional bloating and distension. Around 80% of patients with dyspepsia have no identifiable organic cause and are labeled as functional dyspepsia. Globally, functional dyspepsia prevalence ranges from 11 to 30%. In India, physicians encounter 20-40% of patients with functional dyspepsia, with variations attributed to diagnostic criteria and regions. However, Indian clinical guidelines for functional dyspepsia are currently lacking. Fifty gastroenterologists participated in focus group discussions to create an India-specific algorithm for the diagnosis and management of functional dyspepsia. After several national and regional discussions among groups of gastroenterologists across India, an algorithm was finalized for careful and thorough clinical evaluation of patients presenting with chronic dyspeptic symptoms. This guidance document highlights the role of endoscopic evaluation and Helicobacter pylori infection in the diagnosis of functional dyspepsia, along with the role of proton pump inhibitors (PPIs) and prokinetics in its treatment. The experts also reviewed the use of several prokinetics and provided their views on the choice of drugs for varied clinical presentations of functional dyspepsia. Among prokinetics, the experts believed that itopride was the preferred and relatively safer option for the treatment of functional dyspepsia.

100 Deals associated with Itopride Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D02729	Itopride Hydrochloride	A03FA07	DB04924

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastrointestinal Diseases	India	AbbVie AS	20 Jan 2003
Chronic gastritis	Japan	Viatris Pharmaceutical GK	30 Jun 1995
Heart Failure	China	-	-
Hypertension	China	-	-
Nausea	-	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Irritable bowel syndrome with constipation	Discovery	Pakistan	Abbott Laboratories	01 Jun 2008
Heartburn	Discovery	United States	Forest Laboratories LLC	01 Oct 2006
Intestinal Diseases	Discovery	United States	Axcan Pharma (Australia) Pty Ltd.	01 Nov 2005
Nausea	Discovery	United States	Forest Laboratories, Inc.	01 Aug 2005
Vomiting	Discovery	United States	Forest Laboratories, Inc.	01 Aug 2005
Diabetes Mellitus, Insulin-Dependent, 2	Discovery	Australia	Forest Laboratories, Inc.	01 Mar 2005
Gastroparesis	Discovery	Australia	Forest Laboratories, Inc.	01 Mar 2005
Abdomen distended	Discovery	Canada	Forest Laboratories, Inc.	01 Jul 2004
Dyspepsia	Discovery	Germany	Abbott India Ltd.	01 Dec 2000

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2018	Not Applicable	-	-	Itopride 50mg	pisynglzia(acwuloylls) = qcpdsaelus lnozuuogrg (dmqwwjezfu, 25)	-	01 Oct 2018
				Itopride 100mg	pisynglzia(acwuloylls) = mdstxcixay lnozuuogrg (dmqwwjezfu, 32)
ASCO2005	Not Applicable	Postoperative ileus	-	Itopride hydrochloride 50 mg	(gtdjdxtmkj) = mcfmaahhob mbhmcxvwhv (ycjsxhkpzq ) View more	-	01 Jun 2005
				Placebo	(gtdjdxtmkj) = efirjxjsly mbhmcxvwhv (ycjsxhkpzq ) View more