Clinical Trials
Across numerous clinical trials spanning Early Phase 1 through Phase 4, loperamide hydrochloride has been evaluated as both a primary therapeutic agent and a supportive care intervention. Clinical investigations focus on gastrointestinal conditions such as chemotherapy-related diarrhea, low anterior resection syndrome, and intestinal obstruction, as well as supportive management during treatment for breast neoplasms and advanced gynecologic malignancies. Spearheaded by major academic and pharmaceutical sponsors including Janssen Research & Development, Eli Lilly, and the National Cancer Institute, the portfolio encompasses diverse recruitment statuses, ranging from completed Phase 1 pharmacological evaluations to actively recruiting protocols assessing bowel function restoration.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07605728 | RECRUITING | Breast Cancer; Chemotherapy-induced Diarrhea |
Leeuwenhoek Laboratories Co. Ltd. |
2026-05-15 | PHASE2 |
| NCT06424522 | RECRUITING | Low Anterior Resection Syndrome; Rectal Carcinoma |
Ohio State University Comprehensive Cancer Center |
2026-08-15 | |
| NCT04038619 | RECRUITING | Colitis; Diarrhea; Malignant Genitourinary System Neoplasm; Melanoma; Lung Cancer; Ovarian Cancer; Uterine Cancer; Breast Cancer; Cervical Cancer |
M.D. Anderson Cancer Center |
2021-02-01 | PHASE1 |
| NCT06148025 | RECRUITING | Vaccine Response Impaired |
South Australian Health and Medical Research Institute |
2023-11-23 | PHASE4 |
| NCT07756359 | NOT_YET_RECRUITING | Pouch, Ileal; Pouches, Ileoanal; Bowel Diseases, Inflammatory |
University of North Carolina, Chapel Hill |
2026-09 | PHASE4 |
| NCT05528848 | ACTIVE_NOT_RECRUITING | Healthy; Opioid Use Disorder |
University of Pennsylvania |
2022-09-20 | PHASE1 |
| NCT06892093 | RECRUITING | HER2-positive Breast Cancer; Diarrhea Caused by Drug; Neratinib |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2025-08-07 | |
| NCT07426822 | RECRUITING | Metastatic HR+/HER2- Breast Cancer |
Maryam Lustberg |
2026-08-15 | PHASE2 |
| NCT05577845 | RECRUITING | LARS - Low Anterior Resection Syndrome |
Seoul National University Hospital |
2023-03-27 | |
| NCT05677282 | RECRUITING | Diarrhoea;Acute; Diarrhea Travelers |
Henry M. Jackson Foundation for the Advancement of Military Medicine |
2022-10-28 | PHASE4 |
| NCT02858310 | COMPLETED | Papillomavirus Infections; Cervical Intraepithelial Neoplasia; Carcinoma In Situ; Vulvar Neoplasms; Vulvar Diseases |
National Cancer Institute (NCI) |
2017-01-27 | PHASE1; PHASE2 |
| NCT06865677 | TERMINATED | Recurrent Platinum Resistant Epithelial Ovarian Carcinoma; Recurrent Epithelial Endometrial Carcinoma; Recurrent Epithelial Cervical Carcinoma |
National Cancer Institute (NCI) |
2025-06-09 | PHASE2 |
| NCT05252988 | ACTIVE_NOT_RECRUITING | Early-stage Breast Cancer; HER2 Positive Breast Cancer; Hormone Receptor Positive |
Spanish Breast Cancer Research Group |
2022-08-31 | PHASE2 |
| NCT01391962 | COMPLETED | Sarcoma, Alveolar Soft Part |
National Cancer Institute (NCI) |
2011-07-18 | PHASE2 |
| NCT05520723 | COMPLETED | Triple Negative Breast Cancer; Breast Cancer; Advanced HR+/HER2- Breast Cancer |
MedSIR |
2023-02-06 | PHASE2 |
| NCT03030417 | COMPLETED | Solid Tumors; Lymphoma |
National Cancer Institute (NCI) |
2017-02-27 | PHASE1 |
| NCT04823065 | COMPLETED | Endometrial Cancer; Ovarian Cancer |
Centre de recherche du Centre hospitalier universitaire de Sherbrooke |
2018-09-01 | PHASE1; PHASE2 |
| NCT04736186 | UNKNOWN | Breast Cancer |
Tianjin Medical University Cancer Institute and Hospital |
2020-05-16 | PHASE2; PHASE3 |
| NCT03094052 | COMPLETED | HER2-positive Breast Cancer; Breast Adenocarcinoma; Stage II Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage III Breast Cancer AJCC v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7 |
University of California, San Francisco |
2018-10-09 | PHASE2 |
| NCT05252546 | COMPLETED | HER2-positive Recurrent / Metastatic Breast Cancer |
Jiangsu HengRui Medicine Co., Ltd. |
2022-03-08 | PHASE1 |
| NCT04172597 | TERMINATED | Breast Cancer; Colorectal Cancer; Solid Tumor; Glioblastome Multiforme |
Spectrum Pharmaceuticals, Inc |
2019-12-23 | PHASE2 |
| NCT04366713 | COMPLETED | HER2 Amplified Breast Cancer |
Puma Biotechnology, Inc. |
2020-06-30 | PHASE2 |
| NCT04225078 | COMPLETED | Healthy Participants |
Janssen Research & Development, LLC |
2020-01-17 | PHASE1 |
| NCT02686645 | UNKNOWN | Clostridium Difficile Infection |
Queen Elizabeth II Health Sciences Centre |
2016-12 | PHASE2; PHASE3 |
| NCT04447443 | WITHDRAWN | Chemotherapy-related Diarrhea |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2020-06-30 | |
| NCT02400476 | COMPLETED | Early Stage HER2+ Breast Cancer |
Puma Biotechnology, Inc. |
2015-02 | PHASE2 |
| NCT02057133 | ACTIVE_NOT_RECRUITING | Breast Neoplasms |
Eli Lilly and Company |
2014-03-10 | PHASE1 |
| NCT04315116 | COMPLETED | Healthy Participants |
Jiangsu HengRui Medicine Co., Ltd. |
2020-04-13 | PHASE1 |
| NCT03705442 | UNKNOWN | Colorectal Cancer Metastatic |
Marin Golčić |
2018-02-09 | PHASE2 |
| NCT04225078 | Completed | Healthy Participants |
Janssen Research & Development LLC |
2020-01-17 | Phase 1 |
| NCT04186936 | COMPLETED | Healthy |
McNeil AB |
2019-12-05 | PHASE1 |
| NCT03017430 | COMPLETED | Opioid Withdrawal |
St. Petersburg Bekhterev Research Psychoneurological Institute |
2014-01 | PHASE4 |
| NCT02747004 | ACTIVE_NOT_RECRUITING | Metastatic Breast Cancer |
Eli Lilly and Company |
2016-09-14 | PHASE2 |
| NCT03501498 | COMPLETED | Intestinal Transit |
University Hospital Plymouth NHS Trust |
2017-04-10 | |
| NCT02888899 | UNKNOWN | Fecal Incontinence |
University Hospital, Linkoeping |
2016-03 | |
| NCT02959983 | COMPLETED | Irritable Bowel Syndrome With Diarrhea |
Allergan |
2016-10-25 | PHASE4 |
| NCT02354768 | TERMINATED | High Output Stoma |
University Hospital, Strasbourg, France |
2015-10-22 | PHASE3 |
| NCT02517957 | UNKNOWN | Eczema |
Shanghai Yueyang Integrated Medicine Hospital |
2015-08 | PHASE2 |
| NCT02263365 | TERMINATED | Dehydration, Diverting Ileostomy, Loperamide |
Cedars-Sinai Medical Center |
2014-10-07 | PHASE3 |
| NCT02441946 | COMPLETED | Breast Cancer; Hormone Receptor Positive Tumor; Early-Stage Breast Carcinoma |
Eli Lilly and Company |
2015-08 | PHASE2 |
| NCT02677844 | COMPLETED | Healthy |
Eli Lilly and Company |
2016-02 | PHASE1 |
| NCT01668147 | COMPLETED | Drug Effects |
Washington University School of Medicine |
2012-08 | PHASE1; PHASE2 |
| NCT02008565 | COMPLETED | Fecal Incontinence |
NICHD Pelvic Floor Disorders Network |
2014-02 | PHASE3 |
| NCT01618591 | TERMINATED | Acute Watery Diarrhea; Dysentery/Febrile Diarrhea |
Uniformed Services University of the Health Sciences |
2012-09 | |
| NCT02711891 | COMPLETED | Pain |
Rush University Medical Center |
2015-03 | EARLY_PHASE1 |
| NCT02323516 | WITHDRAWN | Cancer |
Centre Francois Baclesse |
2014-12 | PHASE2 |
| NCT02266849 | TERMINATED | Rectal Cancer; Ulcerative Colitis; Short Bowel Syndrome |
Odense University Hospital |
2014-10 | PHASE3 |
| NCT01814553 | COMPLETED | Carcinoma, Non-Small-Cell Lung |
Boehringer Ingelheim |
2013-04 | PHASE3 |
| NCT02217982 | TERMINATED | Relapsing Remitting Multiple Sclerosis |
Rocky Mountain MS Research Group, LLC |
2014-07 | PHASE4 |
| NCT02099006 | COMPLETED | Female Genital Diseases |
University of Rochester |
2013-11 | PHASE2; PHASE3 |
| NCT01350570 | COMPLETED | Diarrhea-predominant Irritable Bowel Syndrome; Functional Diarrhea |
Chengdu University of Traditional Chinese Medicine |
2011-08 | PHASE2; PHASE3 |
| NCT00591357 | SUSPENDED | Antibiotic-Associated Diarrhea; Clostridium Difficile |
Michael E. DeBakey VA Medical Center |
2007-10 | PHASE4 |
| NCT01780909 | UNKNOWN | Concentration-Time Profiles in Stomach & Intestine. |
KU Leuven |
2013-02 | |
| NCT00727649 | COMPLETED | Fecal Incontinence |
US Department of Veterans Affairs |
2008-07 | PHASE2; PHASE3 |
| NCT01596764 | COMPLETED | Intestinal Obstruction |
University Medicine Greifswald |
2011-05 | PHASE1 |
| NCT00401388 | COMPLETED | Chondrosarcomas; Alveolar Soft Part Sarcomas; Extra Skeletal Myxoid Chondrosarcomas |
AEterna Zentaris |
2006-11 | PHASE2 |
| NCT00933465 | WITHDRAWN | Fecal Incontinence |
University Hospital Southampton NHS Foundation Trust |
2009-10 | PHASE4 |
| NCT01596777 | COMPLETED | Intestinal Obstruction |
University Medicine Greifswald |
2010-01 | PHASE1 |
| NCT00954304 | COMPLETED | Healthy |
Hanmi Pharmaceutical Company Limited |
2009-06 | PHASE1 |
| NCT00807326 | COMPLETED | Diarrhea |
McNeil AB |
2008-11 | PHASE4 |
| NCT00806299 | COMPLETED | Drug Interaction |
Johnson & Johnson Consumer and Personal Products Worldwide |
2008-11 | PHASE1 |
| NCT00685607 | COMPLETED | Diarrhea |
Johnson & Johnson Consumer and Personal Products Worldwide |
2008-10 | PHASE4 |
| NCT00444093 | TERMINATED | Diarrhea; Enteritis; Cancer |
Philipps University Marburg |
2007-03-05 | PHASE3 |
| NCT02340481 | COMPLETED | Diarrhea |
Xian-Janssen Pharmaceutical Ltd. |
2005-07 | PHASE3 |
| NCT02165475 | COMPLETED | Fecal Incontinence |
University Hospital, Linkoeping |
2002-05 | |
| NCT00778115 | COMPLETED | Healthy |
Ranbaxy Laboratories Limited |
2004-11 | |
| NCT00650637 | TERMINATED | Diarrhea |
Pfizer |
2003-01 | PHASE3 |
| NCT00359970 | COMPLETED | Diarrhea |
The University of Texas Health Science Center, Houston |
2002-06 | PHASE4 |
| NCT02251119 | COMPLETED | Healthy |
Boehringer Ingelheim |
2002-07 | PHASE1 |
| NCT00003057 | COMPLETED | Colorectal Cancer; Diarrhea |
Eastern Cooperative Oncology Group |
1997-03-26 | PHASE3 |
| NCT00292344 | COMPLETED | Travelers' Diarrhea |
The University of Texas Health Science Center, Houston |
2004-06 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2026-05-26)
Check the
Loperamide HCl
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
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Note: Technical data last updated: Sep 1, 2026.