Imodium

(loperamide)

ApprovedSmall molecule

Imodium is a small molecule that works as a Mu Opioid Receptor Agonist.[2] It is being used across 13 indications, with its most advanced program in Approved.[1]

Imodium is one of 249 small molecule programs targeting Fecal Incontinence. It is currently in Approved.

Indications

Total Trials

Active Trials

248

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Fecal IncontinenceActive, not recruiting

Clostridium Difficile InfectionActive, not recruiting

Eczematoid DermatitisApproved

Cervical CarcinomaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Intestinal ObstructionApproved

Diarrheal DiseaseActive, not recruiting

Non-Small Cell Lung CancerApproved

Breast CancerActive, not recruiting

Reproductive System DiseaseApproved

Fecal IncontinencePhase 2

Active, not recruiting

Clostridium Difficile InfectionPhase 2/Phase 3

Active, not recruiting

Eczematoid DermatitisApproved

Approved

Cervical CarcinomaPhase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Intestinal ObstructionApproved

Approved

Diarrheal DiseaseApproved

Active, not recruiting

Non-Small Cell Lung CancerApproved

Approved

Breast CancerPhase 2

Active, not recruiting

Reproductive System DiseaseApproved

Approved

Showing 10 of 12 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Imodium

KKenvue Brands

Approved

8 2

Blenoxane

Bristol-Myers Squibb

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Chirocaine

PPurdue Pharma LP

Preclinical

1 5

Vfend

PPrism Pharmaceuticals

Preclinical

—6

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

3 7

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

1 8

Lipegfilgrastim

Merck & Co.

Preclinical

1 9

Tianeptine

Pfizer

Preclinical

1 10

Naltrexone/bupropion

Novo Nordisk

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Breast Cancer

NCT02057133

Q4 2027

N/ARecruiting

Breast Cancer

NCT06892093

Phase 1Recruiting

Diarrhea

NCT04038619

Q2 2029

Phase 2Not yet recruiting

Diarrhea

NCT07426822

Q1 2030

Phase 2Active, not recruiting

Breast Cancer

NCT05252988

Clinical

Trials by Indication[1]

Diarrhea8 trials

Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct

Recruiting·HHenry M. Jackson Foundation for the Advancement of Military Medicine·Phase 4·NCT05677282·150 enrolled

Azithromycin, With or Without Loperamide, to Treat Travelers' Diarrhea

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT00359970·176 enrolled

Acupuncture for Patients With Diarrhea-predominant IBS or Functional Diarrhea: a Randomized Controlled Trial

Completed·—·Phase 2/3·NCT01350570·449 enrolled

Show 5 more trials

A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea

Terminated· Pfizer logo

Pfizer·Phase 3·NCT00650637·17 enrolled

Rash & Diarrhea Prophylaxis With Capivasertib

Not yet recruiting·MMaryam Lustberg·Phase 2·NCT07426822·108 enrolled

ADAM-Afatinib Diarrhea Assessment and Management

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01814553·40 enrolled

Prevention and Treatment of Pyrrolitinib-associated Diarrhea

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2/3·NCT04736186·470 enrolled

Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT04038619·40 enrolled

Breast Cancer8 trials

Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib

Active, not recruiting·SSpanish Breast Cancer Research Group·Phase 2·NCT05252988·177 enrolled

Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib

Completed·UUniversity of California, San Francisco·Phase 2·NCT03094052·11 enrolled

A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT02057133·198 enrolled

Show 5 more trials

Probiotics for Prevention of Neratinib-Induced Diarrhea in Breast Cancer Patients

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·N/A·NCT06892093·308 enrolled

A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib

Completed·PPuma Biotechnology, Inc.·Phase 2·NCT04366713·6 enrolled

Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED

Completed·MMedSIR·Phase 2·NCT05520723·50 enrolled

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

Completed·PPuma Biotechnology, Inc.·Phase 2·NCT02400476·563 enrolled

A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT02441946·224 enrolled

Interaction2 trials

The Pharmacodynamic/Pharmacokinetic Interaction of Tipranavir and Ritonavir With Loperamide in Healthy Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02251119·24 enrolled

A Drug-drug Interaction Trial of Loperamide Pharmacokinetics Effect on Pyrotinib Maleate

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT04315116·18 enrolled

Randomized1 trial

Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study

Terminated·OOdense University Hospital·Phase 3·NCT02266849·12 enrolled

Pain1 trial

Topical Loperamide Gel for Pain Reduction During Repeat Finger Lancing

Completed·RRush University Medical Center·Phase 1·NCT02711891·34 enrolled

18 more indications

Fecal Incontinence1 trial

Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

Completed·UUS Department of Veterans Affairs·Phase 2/3·NCT00727649·80 enrolled

Combination Therapy1 trial

Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents

Completed·UUniversity Hospital, Linkoeping·N/A·NCT02165475

Metastatic Colorectal Cancer1 trial

Probiotics as Adjuvant Therapy in the Treatment of Metastatic Colorectal Cancer

Unknown status·MMarin Golčić·Phase 2·NCT03705442·76 enrolled

Oral1 trial

Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet

Completed· Hanmi Pharmaceutical Company Limited logo

Hanmi Pharmaceutical Company Limited·Phase 1·NCT00954304·30 enrolled

Treatment1 trial

Novel Topical Therapies for the Treatment of Genital Pain

Completed·UUniversity of Rochester·Phase 2/3·NCT02099006·9 enrolled

Adult1 trial

A Study to Evaluate the Effects of Loperamide (JNJ-289679) on Electrocardiogram Intervals in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04225078·66 enrolled

Growth1 trial

A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies

Terminated· Spectrum Pharmaceuticals, Inc logo

Spectrum Pharmaceuticals, Inc·Phase 2·NCT04172597·1 enrolled

MPA1 trial

Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.

Completed·UUniversity Medicine Greifswald·Phase 1·NCT01596764·16 enrolled

Colorectal1 trial

Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies

Terminated·—·Phase 3·NCT02263365·40 enrolled

Clostridium Difficile Infection1 trial

Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection

Unknown status·QQueen Elizabeth II Health Sciences Centre·Phase 2/3·NCT02686645·50 enrolled

Diarrheal Disease1 trial

Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy

Suspended·MMichael E. DeBakey VA Medical Center·Phase 4·NCT00591357·120 enrolled

Pilot Study1 trial

Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation

Terminated·RRocky Mountain MS Research Group, LLC·Phase 4·NCT02217982·5 enrolled

Pyrotinib1 trial

Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Subjects

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT05252546·36 enrolled

Papilloma1 trial

E7 TCR T Cells for Human Papillomavirus-Associated Cancers

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT02858310·224 enrolled

Cervical Carcinoma1 trial

Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT06865677·2 enrolled

Exercise1 trial

Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)

Completed·NNICHD Pelvic Floor Disorders Network·Phase 3·NCT02008565·300 enrolled

Abemaciclib1 trial

A Study of Abemaciclib in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02677844·35 enrolled

Unspecified3 trials

Effects of 500 mg Immediate Release and Extended Release Methylnaltrexone on Loperamide-induced Delay of the Oro-cecal and Whole-gut Transit Time in Healthy Subjects

Completed·UUniversity Medicine Greifswald·Phase 1·NCT01596777·15 enrolled

Tibial Nerve Stimulation in Combination With Biofeedback

Unknown status·UUniversity Hospital, Linkoeping·N/A·NCT02888899

Gut Transit Effect on Enterohepatic Circulation

Completed·UUniversity Hospital Plymouth NHS Trust·N/A·NCT03501498·19 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 — 40 trial records for loperamide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — loperamide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for loperamide. 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

Mechanism of Action: Mu Opioid Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: KKenvue Brands

Imodium

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q2 2029

Q1 2030

Trials by Indication[1]

Diarrhea8 trials

Breast Cancer8 trials

Interaction2 trials

Randomized1 trial

Pain1 trial

Fecal Incontinence1 trial

Combination Therapy1 trial

Metastatic Colorectal Cancer1 trial

Oral1 trial

Treatment1 trial

Adult1 trial

Growth1 trial

MPA1 trial

Colorectal1 trial

Clostridium Difficile Infection1 trial

Diarrheal Disease1 trial

Pilot Study1 trial

Pyrotinib1 trial

Papilloma1 trial

Cervical Carcinoma1 trial

Exercise1 trial

Abemaciclib1 trial

Unspecified3 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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