NDAORALTABLETPriority Review
Approved
Feb 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
6/8 — Strong
Priority Review
LOTRONEX (alosetron hydrochloride) by Enterprise Therapeutics is 5-ht 3 receptor antagonist. Approved for irritable bowel syndrome. First approved in 2000.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOTRONEX is an oral small-molecule 5-HT3 receptor antagonist approved in 2000 for irritable bowel syndrome (IBS). It works by blocking serotonin receptors on enteric neurons to reduce visceral pain, normalize colonic transit, and modulate gastrointestinal secretions in IBS patients. The drug targets the underlying pathophysiology of IBS-related hypersensitivity and hyperactivity.
$1MPart D
LOE ApproachingDeclining
less than 1% of IBS market (major competitors XIFAXAN at $1.1B, VIBERZI at $60M dominate)
LOE-approaching product with minimal claims activity signals limited commercial team investment and consolidation risk.
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 (1)
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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.