MedPath

Itopride

Generic Name
Itopride
Drug Type
Small Molecule
Chemical Formula
C20H26N2O4
CAS Number
122898-67-3
Unique Ingredient Identifier
81BMQ80QRL

Overview

Itopride is a dopamine D2 antagonist with acetylcholinesterase inhibitory actions.

Indication

Investigated for use/treatment in gastrointestinal diseases and disorders (miscellaneous).

Associated Conditions

  • Abdominal Pain
  • Anorexia
  • Dyspepsia
  • Functional Dyspepsia
  • Gastroenteritis
  • Nausea
  • Nausea and vomiting
  • Vomiting
  • Abdominal bloating
  • Pyrosis
  • Stomach discomfort

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
Efficacy of Itopride Versus Metoclopramide in Hospitalized Medicine Patients With High Gastric Residual Volume
2025/06/22
NCT07031479
Phase 4
Not yet recruiting
Chulalongkorn University
Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia
2024/01/22
NCT06217393
Phase 3
Active, not recruiting
Abbott
Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD)
2023/07/28
NCT05966025
Phase 2
Not yet recruiting
October 6 University
Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders
2021/11/26
NCT05134584
Phase 4
UNKNOWN
RenJi Hospital
Helicobacter Pylori Eradication in Functional Dyspepsia
2021/01/06
NCT04697641
Not Applicable
Completed
Sir Ganga Ram Hospital
Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in FD PDS Subgroup
2020/12/01
NCT04647955
Phase 4
Completed
Universitaire Ziekenhuizen KU Leuven
Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial
2020/07/09
NCT04464369
Phase 4
Completed
Universitaire Ziekenhuizen KU Leuven
Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
2019/11/13
NCT04161768
Phase 3
Recruiting
Tanta University
Effectiveness of Prokinetic Agents in Improving Abdominal Discomfort at Colonoscopy
2019/09/26
NCT04104867
Not Applicable
UNKNOWN
Mahidol University
Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition
2018/10/05
NCT03698292
Not Applicable
UNKNOWN
Ain Shams University

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
Itopride Hydrochloride Granules
山东泽宇生物有限公司
国药准字H20050932
化学药品
颗粒剂
3/14/2020
Itopride Hydrochloride Dispersible Tablets
迪沙药业集团有限公司
国药准字H20031270
化学药品
片剂
1/8/2020
Itopride Hydrochloride Tablets
云南永安制药有限公司
国药准字H20040038
化学药品
片剂
9/24/2020
Itopride Hydrochloride Tablets
苏州爱美津制药有限公司
国药准字H20030977
化学药品
片剂
7/24/2020
Itopride Hydrochloride Tablets
迪沙药业集团有限公司
国药准字H20233708
化学药品
片剂
6/14/2023
Itopride Hydrochloride Tablets
珠海润都制药股份有限公司
国药准字H20223071
化学药品
片剂
2/11/2022
Itopride Hydrochloride Tablets
辽宁新高制药有限公司
国药准字H20163183
化学药品
片剂
5/20/2021
Itopride Hydrochloride Tablets
abbott laboratories (m) sdn.bhd
国药准字HJ20160414
化学药品
片剂
5/10/2023
Itopride Hydrochloride Tablets
abbott laboratories (m) sdn.bhd
国药准字HJ20160415
化学药品
片剂
5/10/2023
Itopride Hydrochloride Tablets
丽珠集团丽珠制药厂
国药准字H20010186
化学药品
片剂
4/10/2020

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.

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