Racecadotril

Phase 3Small molecule

MMcNeil AB

Racecadotril is one of 13 small molecule programs targeting Acute Diarrhea. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Acute DiarrheaActive, not recruiting

Acute DiarrheaPhase 3

Active, not recruiting

Competition

Competitive Landscape

16 competitors in Acute Diarrhea

#DrugCompanyPhaseTrials

Xifaxan

SSalix

Approved

1 2

Azulfidine

Pfizer

Phase 3

1 3

Bacillus Clausii

Sanofi

Approved

1 4

Galzin

AAmerican Regent, Inc.

Phase 3

1 5

Oral Anti-Diabetic Drugs

Sanofi

Approved

1 6

Zinc Sulphate

IInternational Centre for Diarrhoeal Disease Research, Bangladesh

Phase 3

1 7

Standard DAPT Duration

FFederico II University

Approved

1 8

Loperamide Hydrochloride

Johnson & Johnson

Phase 3

1 9

Racecadotril

MMcNeil AB

Phase 3

1 10

Racecadotril Plus ORS

AAbbott

Phase 3

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

Timeline

Expected Milestones

Q4 2027

Phase 1/2Not yet recruiting

Injury

NCT07454421

Clinical

Trials by Indication[1]

Diarrhea5 trials

Comparing the Efficacy of Anti-secretory Versus Oral Immunoglobulins for Reducing the Episodes of Diarrhea in Children

Unknown status·SShaheed Zulfiqar Ali Bhutto Medical University·N/A·NCT04885049·60 enrolled

Efficacy of Racecadotril in Acute Watery Diarrhea in Children

Completed·CCentro Pediatrico Albina de Patino·Phase 4·NCT01577043·52 enrolled

Safety and Efficacy of Racecadotril in Children With Acute Watery Diarrhea

Completed·—·N/A·NCT07392931·200 enrolled

Show 2 more trials

Bioequivalence Between a Racecadotril Capsule and Film-Coated Tablet (FCT) to Treat Diarrhea in Adults

Completed·MMcNeil AB·Phase 1·NCT01302093·40 enrolled

Anti-Secretory Drug in Treatment of Acute Watery Diarrhea

Completed·—·Phase 1·NCT05216822·50 enrolled

Injury1 trial

Racecadotril for Organ Injury in Sepsis Patients

Not yet recruiting·ZZhujiang Hospital·Phase 1/2·NCT07454421·44 enrolled

Fasting Conditions1 trial

Bioequivalence Study of Generic Racecadotril 100 mg Capsules Under Fasting Conditions

Unknown status·PPharma Nueva·Phase 1·NCT06297174·44 enrolled

MPA1 trial

Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules

Completed·BBioprojet·Phase 1·NCT01948011·53 enrolled

Treatment1 trial

Racecadotril Versus Standard Treatment in Decreasing the Duration of Acute Diarrhoea in Children

Not yet recruiting·LLiaquat National Hospital & Medical College·Phase 1/2·NCT06529497·260 enrolled

2 more indications

Tics1 trial

Study to Compare the Pharmacokinetics Profiles of Four Racecadotril Products

Completed·MMcNeil AB·Phase 1·NCT01476683·24 enrolled

Acute Diarrhea1 trial

Safety, Efficacy and Cost-effectiveness of Racecadotril in Children With Acute Diarrhea in Mexico

Completed·NNational Institute of Pediatrics, Mexico·Phase 3·NCT01153854·454 enrolled

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Racecadotril. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Racecadotril compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Racecadotril. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — McNeil AB company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: MMcNeil AB

Racecadotril

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Diarrhea5 trials

Injury1 trial

Fasting Conditions1 trial

MPA1 trial

Treatment1 trial

Tics1 trial

Acute Diarrhea1 trial

References

Drug Info

Quick Facts

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