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 7h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Loperamide hydrochloride is an oral antidiarrheal agent that works by binding to opiate receptors in the gut wall to reduce intestinal motility and peristalsis. It is used to treat acute diarrhea and reduce incontinence by increasing anal sphincter tone and prolonging intestinal transit time. The drug inhibits acetylcholine and prostaglandin release, effectively slowing bowel movements.
LOE Approaching
Product is in LOE-approaching phase with moderate competitive pressure (30/100), suggesting commercial teams are transitioning from growth focus to market defense and generic preparation strategies.
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
Career opportunities on this product are limited given zero linked job count and LOE-approaching status, indicating a consolidating commercial footprint. Roles available are primarily in defensive marketing, generic transition planning, and channel management rather than high-growth opportunities.
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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.