NDAORALCAPSULE, EXTENDED RELEASE
Approved
Oct 2008
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
7/8 — 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. First approved in 2008.
Drug data last refreshed 2h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APRISO is an oral extended-release capsule formulation of mesalamine (5-ASA), an aminosalicylate used to treat ulcerative colitis and maintain remission. The mechanism involves local anti-inflammatory effects on colonic epithelial cells, likely by inhibiting arachidonic acid metabolite production (prostanoids and leukotrienes). It is administered orally for direct delivery to the colon.
$7.0MPart D
Peak3.9 years to LOEProduct is at peak commercial maturity with stable Medicare utilization; expect maintenance-focused team structure with moderate headcount.
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…
Pharmacologic Class:
Aminosalicylate
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.