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Itopride,

Phase 3Small molecule

FForest Laboratories

Itopride, is one of 14 small molecule programs targeting Peritonitis. It is currently in Phase 3.

1

Indications

19

Total Trials

2

Active Trials

13

Competitors

Pipeline

Status by Indication[3][1]

Indication

PeritonitisRecruiting

PeritonitisPhase 3

Recruiting

Competition

Competitive Landscape

21 competitors in Peritonitis

#DrugCompanyPhaseTrials

Cipro

Doribax

Vancocin

HHikma Pharmaceuticals LLC

Tygacil

PPrism Pharmaceuticals

Eraxis

VVicuron Pharmaceuticals

Chibroxin

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Extraneal

VVantive Health LLC

Itopride,

FForest Laboratories

Dalvance

Avelox

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Post-ApprovalNot yet recruiting

Age

NCT07449689

Q4 2028

Phase 3Recruiting

Peritonitis

NCT04161768

Clinical

Trials by Indication[1]

Dyspepsia8 trials

Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in FD PDS Subgroup

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT04647955·100 enrolled

Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal

Completed·FForest Laboratories·Phase 3·NCT00112190·645 enrolled

Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

Completed·—·N/A·NCT00599677·720 enrolled

Show 5 more trials

Helicobacter Pylori Eradication in Functional Dyspepsia

Completed·SSir Ganga Ram Hospital·N/A·NCT04697641·202 enrolled

Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT04464369·105 enrolled

Itopride in Functional Dyspepsia:a Dose Finding Study

Completed·RRoyal Adelaide Hospital·Phase 2/3·NCT00272103·500 enrolled

Long-Term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia

Completed·FForest Laboratories·Phase 3·NCT00112203·466 enrolled

Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia

Unknown status·—·N/A·NCT01226134·30 enrolled

Function2 trials

Effects of Itopride on Gastric Motor and Sensory Functions in Healthy Volunteers

Completed·FForest Laboratories·Phase 1/2·NCT00370110·45 enrolled

A Study to Evaluate the Effect of a Medicine on Gastric Functions in Healthy Volunteers.

Completed·MMayo Clinic·Phase 2/3·NCT00308399·45 enrolled

Feeding Intolerance1 trial

Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition

Unknown status·—·N/A·NCT03698292·60 enrolled

Fatty Liver Disease1 trial

Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD)

Unknown status·OOctober 6 University·Phase 2·NCT05966025·60 enrolled

Age1 trial

Comparing Acotiamide and Itopride for the Management of Indigestion

Not yet recruiting·—·Phase 4·NCT07449689·368 enrolled

6 more indications

Bowel Preparation1 trial

Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation

Completed·IInje University·Phase 3·NCT01513096·152 enrolled

Functional Gastrointestinal Disorders1 trial

Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Unknown status·RRenJi Hospital·Phase 4·NCT05134584·78 enrolled

Effectiveness1 trial

Effectiveness of Prokinetic Agents in Improving Abdominal Discomfort at Colonoscopy

Unknown status·MMahidol University·N/A·NCT04104867·525 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Itopride vs Placebo in Heartburn

Completed·FForest Laboratories·Phase 3·NCT00382577·48 enrolled

Gastric Emptying1 trial

Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

Completed·FForest Laboratories·Phase 1/2·NCT00370084·25 enrolled

Peritonitis1 trial

Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Recruiting·TTanta University·Phase 3·NCT04161768·80 enrolled

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for Itopride,. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Itopride, compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Itopride,. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Forest Laboratories company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: FForest Laboratories

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