Itopride

Summary

Itopride (CHEMBL2107457) is a phase-3 clinical-stage small molecule (ATC A03FA07); indicated across 6 conditions including dyspepsia and infectious peritonitis.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Small molecule
• ATC class: A03FA07
• Indications: 6 conditions
• Clinical trials: 21
• Chemistry: 358.4 Da · C20H26N2O4

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2107457
Name	Itopride
Type	Small molecule
Max phase	3
FDA approved	no
PubChem CID	3792
ATC	A03FA07
Molecular formula	C20H26N2O4
Molecular weight	358.4
InChIKey	QQQIECGTIMUVDS-UHFFFAOYSA-N

SMILES: CN(C)CCOC1=CC=C(C=C1)CNC(=O)C2=CC(=C(C=C2)OC)OC

IUPAC name: N-[[4-[2-(dimethylamino)ethoxy]phenyl]methyl]-3,4-dimethoxybenzamide

Also known as: Itoprida, Itopride, NSC-759643, ITOPRIDE, ITOPRIDE HYDROCHLORIDE, itopride

Parent form; salt/anhydrous children: CHEMBL2139257

Patent coverage: 498 distinct patent families (1,678 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 3 (assay-derived). Sample: D(2) dopamine receptor, D(3) dopamine receptor, Histamine H3 receptor.

Bioactivity

ChEMBL activities: 1 potent at pChembl ≥ 5 of 3 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
DRD2	5.02	AC50	9600	nM	CHEMBL_ACT_25140332

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

6 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
dyspepsia	3	MONDO:0002268	EFO:0008533
infectious peritonitis	3	MONDO:0004522	EFO:0008588
irritable bowel syndrome	2	MONDO:0005052	EFO:0000555
constipation disorder	2	MONDO:0002203	HP:0002019
gastroparesis	1	MONDO:0006769	EFO:1000948

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 21.

Phase distribution

Phase	Trials
PHASE3	7
PHASE4	4
Not specified	4
PHASE2/PHASE3	2
PHASE1/PHASE2	2
PHASE2	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT07449689	PHASE4	NOT_YET_RECRUITING	Comparing Acotiamide and Itopride for the Management of Indigestion
NCT04464369	PHASE4	COMPLETED	Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial
NCT04647955	PHASE4	COMPLETED	Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in FD PDS Subgroup
NCT05134584	PHASE4	UNKNOWN	Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders
NCT04161768	PHASE3	RECRUITING	Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
NCT00110968	PHASE3	COMPLETED	Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
NCT00112177	PHASE3	COMPLETED	Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal
NCT00112190	PHASE3	COMPLETED	Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal
NCT00112203	PHASE3	COMPLETED	Long-Term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
NCT00272103	PHASE2/PHASE3	COMPLETED	Itopride in Functional Dyspepsia:a Dose Finding Study
NCT00308399	PHASE2/PHASE3	COMPLETED	A Study to Evaluate the Effect of a Medicine on Gastric Functions in Healthy Volunteers.
NCT00382577	PHASE3	COMPLETED	Efficacy and Safety of Itopride vs Placebo in Heartburn
NCT01513096	PHASE3	COMPLETED	Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation
NCT00370084	PHASE1/PHASE2	COMPLETED	Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia
NCT00370110	PHASE1/PHASE2	COMPLETED	Effects of Itopride on Gastric Motor and Sensory Functions in Healthy Volunteers
NCT01513811	PHASE2	COMPLETED	Itopride as an Adjuvant for Bowel Preparation in Patients With Chronic Constipation is Effective
NCT05966025	PHASE2	UNKNOWN	Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD)
NCT00599677	Not specified	COMPLETED	Randomized Controlled Trial of Acupuncture for Functional Dyspepsia
NCT03698292	Not specified	UNKNOWN	Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition
NCT04104867	Not specified	UNKNOWN	Effectiveness of Prokinetic Agents in Improving Abdominal Discomfort at Colonoscopy
NCT04697641	Not specified	COMPLETED	Helicobacter Pylori Eradication in Functional Dyspepsia

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline, but PharmGKB curates 2 clinical and 2 variant annotation(s) for this drug (gene-keyed; see PharmGKB).

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).