NDAORALTABLET, DELAYED RELEASEPriority Review
Approved
Jan 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
ASACOL (mesalamine) by Viatris (2) is clinical pharmacology: mesalamine is thought to be the major therapeutically active part of the sulfasalazine molecule in the treatment of ulcerative colitis. Approved for ulcerative colitis, crohn's disease. First approved in 1992.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ASACOL (mesalamine) is an oral, delayed-release small molecule indicated for ulcerative colitis and Crohn's disease. It works topically in the colon by inhibiting prostaglandin production and reducing mucosal inflammation. The acrylic-based coating delivers mesalamine to the terminal ileum and beyond, maximizing local therapeutic effect.
LOE Approaching
Product is approaching loss of exclusivity; commercial teams are likely consolidating or preparing transition strategies, with limited headcount expansion expected.
Mechanism of Action
CLINICAL PHARMACOLOGY: Mesalamine is thought to be the major therapeutically active part of the sulfasalazine molecule in the treatment of ulcerative colitis. Sulfasalazine is converted to equimolar amounts of sulfapyridine and mesalamine by bacterial action in the colon. The usual oral dose of…
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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.