NDAORALCAPSULE, EXTENDED RELEASE
Approved
Oct 2008
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
8/8 — Comprehensive
APRISO (mesalamine) by Salix Pharmaceuticals 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 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APRISO is an extended-release oral capsule formulation of mesalamine (5-ASA), a aminosalicylate anti-inflammatory agent approved by the FDA in October 2008. It is indicated for the maintenance of remission of ulcerative colitis in adult patients. The mechanism of action involves local anti-inflammatory effects on colonic epithelial cells, believed to work by blocking production of arachidonic acid metabolites (prostaglandins and leukotrienes) that are elevated in ulcerative colitis patients. APRISO represents a convenient once-daily dosing option in a crowded aminosalicylate market dominated by mesalamine formulations and competing corticosteroid therapies.
$0.0BPart D
4.0 years to LOEMechanism 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…
Pharmacologic Class:
Aminosalicylate
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
Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
Started May 2017
60 enrolled
Ulcerative Colitis
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
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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.