How many clinical trials are studying Loperamide?

3 recruiting trials in our tracked data involve Loperamide.

What conditions is Loperamide being studied for?

In our tracked recruiting trials, Loperamide is being studied in trials for Breast Cancer, Cervical Cancer, Colitis.

Loperamide: clinical trials recruiting now

Q: Is Loperamide FDA-approved?

Yes. According to the FDA drug label available through openFDA, Loperamide is an FDA-approved drug. Its FDA label carries a boxed warning.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Loperamide appears in the FDA drug-label database. Marketed as Loperamide Hydrochloride.
Boxed warning: The FDA label for Loperamide carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.

FDA recalls / enforcement

Reason (FDA)	Classification	Status	Initiated
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets. — Sun Pharmaceutical Industries, Inc.	Class III (FDA: unlikely to cause harm)	Terminated	2018-12-26
cGMP deviations: Temperature abuse — Mckesson Medical-Surgical Inc. Corporate Office	Class II (FDA: may cause temporary or reversible harm)	Terminated	2022-04-13

FDA label via openFDA

Phase breakdown

Phase 1 1 Phase 2 1 Not applicable 1

Conditions being studied

Condition	Trials
Breast Cancer · Loperamide for Breast Cancer	3
Cervical Cancer	1
Colitis	1
Diarrhea	1
Diarrhea Caused by Drug	1
HER2-positive Breast Cancer	1
Lung Cancer	1
Malignant Genitourinary System Neoplasm	1
Melanoma	1
Metastatic HR+/HER2- Breast Cancer	1
Neratinib	1
Ovarian Cancer	1
Uterine Cancer	1

Recruiting trials involving Loperamide

Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients
NCT04038619 · Phase: Phase 1 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Probiotics for Prevention of Neratinib-Induced Diarrhea in Breast Cancer Patients
NCT06892093 · Phase: Not applicable (e.g. observational or device study) · Ages: 18 Years and older · Sex: Female · 1 location
Rash & Diarrhea Prophylaxis With Capivasertib
NCT07426822 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location

Common questions

Is Loperamide FDA-approved?

Yes, marketed as Loperamide Hydrochloride. Its FDA label carries a boxed warning.

How many recruiting trials involve Loperamide?

3 recruiting trials across 13 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.