NDAORALCAPSULE, EXTENDED RELEASEPriority Review
Approved
May 1993
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
PENTASA (mesalamine) by Takeda. Approved for aminosalicylate [epc]. First approved in 1993.
Drug data last refreshed 14h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PENTASA is an oral extended-release capsule formulation of mesalamine, an aminosalicylate indicated for inflammatory bowel disease maintenance and treatment. It works by delivering mesalamine directly to the colon to reduce inflammation in patients with ulcerative colitis and Crohn's disease. The extended-release mechanism allows for sustained therapeutic delivery throughout the GI tract.
$34MPart D
LOE ApproachingDeclining
As LOE approaches, the team will shift focus from growth to retention and lifecycle extension strategies, with potential for smaller focused teams.
Mechanism of Action
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.