NDAORALCAPSULE
Approved
Dec 1976
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
IMODIUM (loperamide hydrochloride) by Johnson & Johnson is mechanism of action in vitro and animal studies show that loperamide hydrochloride capsules act by slowing intestinal motility and by affecting water and electrolyte movement through the bowel. First approved in 1976.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMODIUM (loperamide hydrochloride) is an oral antidiarrheal agent approved in 1976 that treats acute and chronic diarrhea by slowing intestinal motility and reducing propulsive peristalsis. It works by binding to opiate receptors in the gut wall, inhibiting acetylcholine and prostaglandin release while increasing anal sphincter tone to reduce urgency and incontinence.
LOE Approaching
As LOE approaches, brand teams are likely in transition or consolidation mode with reduced headcount; focus shifts from growth to market maintenance and generic transition planning.
Mechanism of Action
Mechanism of Action In vitro and animal studies show that loperamide hydrochloride capsules act by slowing intestinal motility and by affecting water and electrolyte movement through the bowel. Loperamide binds to the opiate receptor in the gut wall. Consequently, it inhibits the release of…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers
Started Dec 2019
48 enrolled
Healthy
Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence
Started Jul 2005
217 enrolled
Diarrhea
Career Relevance
Working on IMODIUM offers stability in a legacy franchise but limited growth opportunities given LOE trajectory and mature market saturation. Career progression may be constrained; roles emphasize cost management, generic competition response, and market maintenance rather than innovation or expansion.
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.