NDAORALTABLETPriority Review
Approved
Feb 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
LOTRONEX (alosetron hydrochloride) by Enterprise Therapeutics is 5-ht 3 receptor antagonist. First approved in 2000.
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOTRONEX (alosetron hydrochloride) is an oral small-molecule 5-HT3 receptor antagonist approved for irritable bowel syndrome with diarrhea (IBS-D) in women. It modulates the enteric nervous system to reduce visceral pain, colonic transit abnormalities, and gastrointestinal secretions characteristic of IBS pathophysiology.
$0.001BPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with minimal Medicare claims (243 in 2023), signaling a mature/declining franchise requiring defensive commercialization strategies.
Mechanism of Action
5-HT 3 receptor antagonist. 5-HT 3 receptors are ligand-gated cation channels that are extensively distributed on enteric neurons in the human gastrointestinal tract, as well as other peripheral and central locations. Activation of these channels and the resulting neuronal depolarization affect the…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Safety and Efficacy Study of GR68755 (Alosetron Hydrochloride) to Treat Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS)
Started Sep 2003
32 enrolled
Irritable Colon
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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.