NDAORALCAPSULE
Approved
Aug 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
LOPERAMIDE HYDROCHLORIDE (loperamide hydrochloride) by Design Pharmaceuticals 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 2005.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Loperamide hydrochloride is an oral antidiarrheal agent that acts as an opiate receptor agonist in the gut wall. It slows intestinal motility, reduces propulsive peristalsis, and increases anal sphincter tone to control diarrhea and urgency. The drug has been a standard OTC and prescription treatment for acute and chronic diarrhea since its 2005 NDA approval.
LOE Approaching
Product is entering loss-of-exclusivity phase with high generic competition (30% competitive pressure), signaling smaller dedicated teams and focus on cost management and line extensions.
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 loperamide offers limited growth trajectory but strong defensive commercial strategy experience in a mature, highly competitive market. Roles emphasize cost management, generic defense, pricing strategy, and stakeholder relations rather than innovation or product launch.
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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.