Drugs / Loperamide
Loperamide
also known as
imodium · Loperamide Hydrochloride · Arret · Chlorhydrate of Loperamide · Diah-limit · Diaquitte · Diareze · Diarrhoea relief · +28 more
Small molecule targets OPRM1 via activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | IMODIUM A-D | — | 1992-11-23 | fda.gov ↗ |
| Approved | US (FDA) | IMODIUM | — | 1976-12-28 | fda.gov ↗ |
Trials 31 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02711891 | Mar → Dec 2015 | — | Rush University Medical Center | Completed | No outcome recorded |
| Phase 17 trials | ||||||
| Phase 1 | NCT05252546 | Mar → Aug 2022 | HER2 positive breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04315116 | Apr 2020 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04225078 | Jan 2020 → Dec 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04186936 | Dec 2019 | — | McNeil AB | Completed | No outcome recorded |
| Phase 1 | NCT02677844 | Feb → Jul 2016 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT00806299 | Nov 2008 | — | Johnson & Johnson Consumer and Personal Products Worldwide | Completed | No outcome recorded |
| Phase 1 | NCT02251119 | Jul 2002 → Jan 2003 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04823065 | Sep 2018 → Aug 2023 | endometrial cancer, ovarian cancer | Centre de recherche du Centre hospitalier universitaire de Sherbrooke | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07426822 | Apr 2026 → Apr 2027 expected | hormone receptor-positive breast cancer | Maryam Lustberg | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05252988 | Aug 2022 → Oct 2024 overdue | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer | Spanish Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05154396 | Jan 2022 → Dec 2023 | HER2 positive breast carcinoma | Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT04576208 | Nov 2020 → Jul 2022 | non-small cell lung carcinoma | Takeda | Withdrawn | No outcome recorded |
| Phase 2 | NCT02400476 | Feb 2015 → Apr 2021 | HER2 positive breast carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04736186 | May 2020 → Oct 2022 | breast cancer | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT02099006 | Nov 2013 → Jun 2015 | female reproductive system disorder | University of Rochester | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT02263365 | Oct 2014 → Dec 2016 | diversion colitis | Cedars-Sinai Medical Center | Terminated | No outcome recorded |
| Phase 3 | NCT02008565 | Feb 2014 → May 2016 | — | NICHD Pelvic Floor Disorders Network | Completed | No outcome recorded |
| Phase 3 | NCT01814553 | Apr 2013 → Jul 2015 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00444093 | Mar 2007 → Feb 2008 | cancer, diarrheal disease, enteritis | Philipps University Marburg | Terminated | No outcome recorded |
| Phase 3 | NCT00003057 | Mar 1997 → May 2000 | colorectal cancer, diarrheal disease | Eastern Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT00933465 | Oct 2009 → May 2010 | — | University Hospital Southampton NHS Foundation Trust | Withdrawn | No outcome recorded |
| Phase 4 | NCT00807326 | Nov 2008 → Aug 2009 | diarrheal disease | McNeil AB | Completed | No outcome recorded |
| Phase 4 | NCT00685607 | Oct 2008 | acute diarrhea | Johnson & Johnson Consumer and Personal Products Worldwide | Completed | No outcome recorded |
| Phase 4 | NCT00292344 | Jun 2004 → Aug 2005 | acute diarrhea | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 4 | NCT00359970 | Jun 2002 → Aug 2003 | diarrheal disease | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT03501498 | Apr 2017 → May 2018 | — | University Hospital Plymouth NHS Trust | Completed | No outcome recorded |
| — | NCT01780909 | Feb → Dec 2013 | — | KU Leuven | Unknown | No outcome recorded |
| — | NCT01717456 | Jan 2013 → Mar 2015 | — | University of North Carolina, Chapel Hill | Terminated | No outcome recorded |
| — | NCT01618591 | Sep 2012 → Mar 2016 | dysentery | Uniformed Services University of the Health Sciences | Terminated | No outcome recorded |
| — | NCT02165475 | May 2002 → Mar 2005 | — | University Hospital, Linkoeping | Completed | No outcome recorded |
Also used as a comparator or background therapy in 35 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT05528848 Background | Sep 2022 → Sep 2027 expected | substance-related disorder | University of Pennsylvania | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04038619 Background | Feb 2021 → Dec 2027 expected | breast cancer, cervical cancer, colitis, diarrheal disease +4 | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT02057133 Background | Mar 2014 → Mar 2021 overdue | breast neoplasm | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01596764 Comparator | May → Jul 2011 | intestinal obstruction | University Medicine Greifswald | Completed | No outcome recorded |
| Phase 1 | NCT01596777 Comparator | Jan → Mar 2010 | intestinal obstruction | University Medicine Greifswald | Completed | No outcome recorded |
| Phase 1 | NCT00954304 Background | Jun → Aug 2009 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02858310 Background | Jan 2017 → Jul 2025 | cervical intraepithelial neoplasia, human papilloma virus infection, in situ carcinoma, vulvar neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT06865677 Background | Jun → Jul 2025 | cervical carcinoma, endometrial carcinoma, ovarian carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT05520723 Background | Feb → Oct 2023 | hormone receptor-positive breast cancer, triple-negative breast carcinoma | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT04366713 Background | Jun 2020 → Dec 2021 | HER2 positive breast carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04172597 Background | Dec 2019 → Mar 2022 | breast cancer, colorectal cancer, glioblastoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 2 | NCT03094052 Background | Oct 2018 → Oct 2022 | HER2 positive breast carcinoma, breast adenocarcinoma | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2 | NCT03705442 Background | Feb 2018 → Feb 2020 | colorectal cancer | Marin Golčić | Unknown | No outcome recorded |
| Phase 2 | NCT02747004 Background | Sep 2016 → Jun 2018 overdue | breast cancer | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02441946 Background | Aug 2015 → Aug 2016 | hormone receptor-positive breast cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT02323516 Comparator | Dec 2014 → Dec 2015 | cancer | Centre Francois Baclesse | Withdrawn | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT02686645 Background | Dec 2016 → Dec 2021 | Clostridium difficile colitis | Queen Elizabeth II Health Sciences Centre | Unknown | No outcome recorded |
| Phase 2/3 | NCT01350570 Comparator | Aug 2011 → Feb 2014 | functional diarrhea, irritable bowel syndrome | Chengdu University of Traditional Chinese Medicine | Completed | No outcome recorded |
| Phase 2/3 | NCT00727649 Comparator | Jul 2008 → Oct 2013 | — | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT02354768 Background | Oct 2015 → Dec 2017 | — | University Hospital, Strasbourg, France | Terminated | No outcome recorded |
| Phase 3 | NCT02266849 Comparator | Oct 2014 → Aug 2015 | rectal cancer, short bowel syndrome, ulcerative colitis | Odense University Hospital | Terminated | No outcome recorded |
| Phase 3 | NCT02340481 Comparator | Jul 2005 → May 2006 | diarrheal disease | Xian-Janssen Pharmaceutical Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00650637 Background | Jan → Aug 2003 | diarrheal disease | Pfizer | Terminated | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT06148025 Background | Nov 2023 → Oct 2027 expected | — | South Australian Health and Medical Research Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT05677282 Background | Oct 2022 → Sep 2025 overdue | acute diarrhea | Henry M. Jackson Foundation for the Advancement of Military Medicine | Recruiting | No outcome recorded |
| Phase 4 | NCT02217982 Comparator | Jul 2014 → Jun 2015 | relapsing-remitting multiple sclerosis | Rocky Mountain MS Research Group, LLC | Terminated | No outcome recorded |
| Phase 4 | NCT03017430 Background | Jan 2014 → Dec 2019 | substance withdrawal syndrome | St. Petersburg Bekhterev Research Psychoneurological Institute | Completed | No outcome recorded |
| Phase 4 | NCT00591357 Comparator | Oct 2007 → Dec 2013 | Clostridium difficile colitis, diarrheal disease | Michael E. DeBakey VA Medical Center | Suspended | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT06424522 Background | Aug 2026 → Dec 2028 expected | rectal carcinoma | Ohio State University Comprehensive Cancer Center | Recruiting | No outcome recorded |
| — | NCT07635394 Background | Apr 2026 overdue | irritable bowel syndrome | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT06892093 Background | Aug 2025 → Jun 2027 expected | HER2 positive breast carcinoma, diarrheal disease | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| — | NCT06235931 Background | Feb 2024 → Dec 2025 overdue | breast neoplasm | Second Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| — | NCT05920681 Background | Jun 2023 → May 2025 | — | National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos | Unknown | No outcome recorded |
| — | NCT03215017 Comparator | May 2017 → Dec 2022 | — | Mirna Abraham-Nordling | Completed | No outcome recorded |
| — | NCT02888899 Background | Mar 2016 → Mar 2018 | — | University Hospital, Linkoeping | Unknown | No outcome recorded |
Evidence & citations 41 cited values
Every value below carries the sentence it was read from. 67 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Loperamide | “Loperamide prophylaxis: 4mg three times daily on days 1-14 and 4mg twice daily on days 15-56, followed by as needed, not exceeding 16mg/ day.” NCT05154396 ↗59“Loperamide: 2-4 mg after each loose stool (max 16 mg/day) to reduce stool frequency, though it does not relieve pain” NCT07635394 ↗ “Medication to help control of the bowel movement (One or a combination of Loperamide, Sorbitol, Sterculia gum)” NCT03215017 ↗ “Antidiarrheal prophylaxis includes loperamide tablet administered as per routine clinical practice.” NCT04576208 ↗ “Drug: Loperamide” NCT07426822 ↗ |
| Known as | Arret | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Chlorhydrate of Loperamide | “* Chlorhydrate of Loperamide (2 mg capsule or tablet) 6 / day for 72 hours (D0 to D3)” NCT02354768 ↗ |
| Known as | Diah-limit | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Diaquitte | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Diareze | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Diarrhoea relief | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Diasorb | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Diocalm | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Diocaps | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Dioraleze | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Entrocalm | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Gppe pack | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | imodium | “Antidiarrheal regimen 1: Oral imodium (2 tablets/times, 2 times a day) from the first week, 1 tablet, 2 times a day from the second week.” NCT06235931 ↗4“Loperamide is a standard treatment for diarrhea, and is available over the counter under the name, Imodium.” NCT00591357 ↗ “rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin” NCT00292344 ↗ “Imodium at a starting dose of 2 mg/day may be used for diarrhea if unresponsive to fiber.” NCT01717456 ↗ “Imodium (Loperamide Hydrochloride) syrup” NCT00933465 ↗ |
| Known as | Imodium (loperamide) | “Imodium (loperamide)” NCT01717456 ↗ |
| Known as | Imodium a-d | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Imodium a-d ez chews | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Imodium advanced | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Imodium classic | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Imodium ibs relief | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Imodium instant melts | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Imodium instants | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Imodium liquicaps | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Lodiar | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Loperagen | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Loperamid | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00444093 ↗ |
| Known as | Loperamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Loperamide hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Loperamide Hydrochloride | “Imodium (Loperamide Hydrochloride) syrup” NCT00933465 ↗ |
| Known as | Loperamide hydrochloride component of imodium multi-symptom relief | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Loperamidi hydrochloridum | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Loperamidum | “Loperamidum Dosage form: Loperamide Tablets (2mg of loperamide hydrochloride.). Dosage: Initial dose - 2 tablets immediately, then - 1 tablet after each loose stool, but not...” NCT05920681 ↗ |
| Known as | Norimode | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Normaloe | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | NSC-696356 | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | R 18,553 | ChEMBL registry synonym — accepted as the source's own label CHEMBL841 ↗ |
| Known as | Seldiar | “loperamide ("Seldiar")” NCT03705442 ↗ |
| Action | Activate | “Loperamide is an opioid agonist” NCT01596777 ↗1“Mu opioid receptor agonist” CHEMBL841 ↗ |
| Modality | Small molecule | “Loperamide, a piperdine derivative with a structure similar to the synthetic opioid meperidine” NCT02711891 ↗ |
| Route | Oral | “Patients in arm C receive oral doses of loperamide following each unformed stool for 5 days” NCT00003057 ↗ |
| Target | OPRM1 | “Mu opioid receptor agonist” CHEMBL841 ↗ |