Last update 25 Oct 2025

Loperamide Hydrochloride/Dimethicone

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
LOPERAMIDE HYDROCHLORIDE/SIMETHICONE, Imodium Multi-symptom Relief
Target
Opioid receptors
Action
agonists
Mechanism
Opioid receptors agonists(Opioid receptors agonists)
Therapeutic Areas
Nervous System DiseasesOther Diseases
Active Indication
Acute diarrheaAbdomen distendedDiarrhea+ [1]
Inactive Indication
Muscle Cramp
Originator Organization
Johnson & Johnson Holdco (NA), Inc.Johnson & Johnson Holdco (NA), Inc.
Active Organization
Johnson & Johnson de Colombia SABiotech Pharmaceuticals Pty Ltd
Inactive Organization
Johnson & Johnson Holdco (NA), Inc.Johnson & Johnson Holdco (NA), Inc.
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (26 Jun 1997),
DiarrheaGastrointestinal spasmMuscle Cramp
Regulation-
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Structure/Sequence

Molecular FormulaC29H34Cl2N2O2
InChIKeyPGYPOBZJRVSMDS-UHFFFAOYSA-N
CAS Registry34552-83-5

Related

4
Clinical Trials associated with Loperamide Hydrochloride/Dimethicone
NCT04186936
/ CompletedPhase 1
An Open-label, Randomized, Fasting, Two-period, Single-dose, Crossover Study to Assess Bioequivalence Between a Combination Caplet With Loperamide Hydrochloride and Simethicone (Janssen-Cilag, France), and Imodium® Express Tablets-lyophilizate (Janssen-Cilag, France) Coadministered With Espumisan® Capsule (Berlin-Chemie AG, Germany), in Healthy Volunteers
NCT00807326
/ CompletedPhase 4
A Randomized, Parallel Group Comparison of Loperamide/Simeticone Caplet, Loperamide/Simeticone Chewable Tablet (IMODIUM® PLUS) and a Probiotic (Saccharomyces Boulardii) in the Treatment of Acute Diarrhea in Adults
NCT00685607
/ CompletedPhase 4
A Placebo-Controlled, Double-Blind, Randomized Pilot Study to Evaluate the Appropriateness of Multiple Endpoints in Measuring the Onset of Clinical Efficacy of Loperamide-Simethicone Caplets in the Treatment of Acute Non-specific Diarrhea
100 Clinical Results associated with Loperamide Hydrochloride/Dimethicone
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100 Translational Medicine associated with Loperamide Hydrochloride/Dimethicone
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100 Patents (Medical) associated with Loperamide Hydrochloride/Dimethicone
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100 Deals associated with Loperamide Hydrochloride/Dimethicone
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acute diarrhea
Australia
Biotech Pharmaceuticals Pty Ltd
08 Aug 2012
Abdomen distended
United States
Johnson & Johnson de Colombia SA
30 Nov 2000
Diarrhea
United States
Johnson & Johnson Holdco (NA), Inc.Johnson & Johnson Holdco (NA), Inc.
26 Jun 1997
Gastrointestinal spasm
United States
Johnson & Johnson Holdco (NA), Inc.Johnson & Johnson Holdco (NA), Inc.
26 Jun 1997
Muscle Cramp
United States
Johnson & Johnson Holdco (NA), Inc.Johnson & Johnson Holdco (NA), Inc.
26 Jun 1997
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date

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Approval

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Regulation

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