NDARECTALENEMAPriority Review
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
ROWASA (mesalamine) by Viatris (2) is understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. First approved in 1987.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ROWASA is a rectal enema formulation of mesalamine, an aminosalicylate anti-inflammatory agent used to treat ulcerative colitis. It works by topically reducing prostaglandin production and blocking arachidonic acid metabolite pathways in colonic epithelial cells. This localized delivery approach targets inflammation directly at the site of disease.
$0.069BPart D
LOE ApproachingDeclining
1.1 years to LOEBrand is in terminal phase with minimal linked job openings; expect team consolidation and transition focus toward cost management and generic defense strategies.
Mechanism of Action
understood, but appears to be a topical 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 hydroxyeicosatetraenoic acids,…
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
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.