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 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Loperamide hydrochloride is an oral antidiarrheal capsule that acts as an opiate receptor agonist in the gut wall, slowing intestinal motility and reducing propulsive peristalsis. It is used to treat acute and chronic diarrhea by increasing intestinal transit time and anal sphincter tone, thereby reducing incontinence and urgency. The drug works by inhibiting acetylcholine and prostaglandin release in the bowel.
LOE Approaching
As LOE approaches, the brand team is likely consolidating and shifting focus toward generic transition planning and cost management 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
Working on loperamide hydrochloride offers limited career growth opportunities given its mature, LOE-approaching lifecycle and lack of active clinical development. Professionals joining this product should expect defensive market management, generic transition planning, and focus on profitability optimization rather than innovation-driven innovation.
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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.