NDAORALTABLET, DELAYED RELEASE
Approved
May 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
ASACOL HD (mesalamine) by AbbVie is (5-asa) is not fully understood, but appears to be a local anti-inflammatory effect on colonic epithelial cells. Approved for ulcerative colitis. First approved in 2008.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ASACOL HD is an oral delayed-release tablet containing mesalamine (5-ASA), a small-molecule anti-inflammatory agent approved for ulcerative colitis, Crohn's disease, proctitis, and colitis. The drug works through local anti-inflammatory effects on colonic epithelial cells, likely by blocking arachidonic acid metabolites including prostanoids and leukotrienes. It is indicated for multiple inflammatory bowel conditions and has off-label consideration in colorectal cancer prevention.
$0.076BPart D
LOE ApproachingProduct is approaching loss of exclusivity with minimal current spending (~$76K in 2023), suggesting declining market presence and reduced team investment.
Mechanism of Action
(5-ASA) is not fully understood, but appears to be a local anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and…
Indications (1)
Clinical Trials (20)
A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis
Started Sep 2025
0Ulcerative Colitis (UC)
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
Started Mar 2022
150 enrolled
Lynch SyndromeColon CancerColon Neoplasm
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
Started Nov 2017
8 enrolled
Colorectal Cancer
A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)
Started Jul 2016
25 enrolled
Ulcerative Colitis
Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
Started Feb 2016
276 enrolled
Ulcerative Colitis
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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.