Imodium

(Loperamide Hydrochloride)

Phase 1Small molecule

KKenvue Brands

Imodium is one of 10 small molecule programs targeting Opioid. It is currently in Phase 1.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

OpioidRecruiting

Low Anterior Resection SyndromeRecruiting

OpioidPhase 1

Recruiting

Low Anterior Resection SyndromePreclinical

Recruiting

Competition

Competitive Landscape

12 competitors in Opioid

#DrugCompanyPhaseTrials

Oxycontin

PProtega

Phase 3

4 2

Revia

Teva

Phase 2

6 3

Epidiolex

Jazz Pharmaceuticals

Phase 2

1 4

Suboxone

Merck & Co.

Phase 3

1 5

Narcan

SScienture

Phase 1

7 6

DOVATO

GSK

Phase 3

1 7

Alfenta

Jazz Pharmaceuticals

Preclinical

1 8

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

1 9

Imodium

KKenvue Brands

Phase 1

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

Timeline

Expected Milestones

Q4 2028

N/ARecruiting

Low Anterior Resection Syndrome

NCT06424522

Clinical

Trials by Indication[1]

Colorectal Cancer1 trial

Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00003057·500 enrolled

Acute Diarrhea1 trial

Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02340481·217 enrolled

Opioid1 trial

Multi-System Analysis of Opioid Receptor Binding

Recruiting·UUniversity of Pennsylvania·Phase 1·NCT05528848·60 enrolled

Low Anterior Resection Syndrome1 trial

A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients

Recruiting·OOhio State University Comprehensive Cancer Center·N/A·NCT06424522·80 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

IMODIUM

NDA NDA017690

Jan 1, 1982

IMODIUM

NDA NDA017694

Jul 31, 1984

IMODIUM

NDA NDA019037

Mar 1, 1988

IMODIUM A-D

NDA NDA019487

Nov 22, 1989

IMODIUM A-D

NDA NDA019860

Jul 24, 1997

IMODIUM A-D EZ CHEWS

NDA NDA020448

Aug 4, 2005

LOPERAMIDE HYDROCHLORIDE

NDA NDA021855

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Loperamide Hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Loperamide Hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Loperamide Hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021855). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Kenvue Brands company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: KKenvue Brands

Imodium

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Trials by Indication[1]

Colorectal Cancer1 trial

Acute Diarrhea1 trial

Opioid1 trial

Low Anterior Resection Syndrome1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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