PENTASA

LOE Approaching

mesalamine

NDAORALCAPSULE, EXTENDED RELEASEPriority Review
Approved
May 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20

Mechanism of Action

understood, but it 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…

Pharmacologic Class:

Aminosalicylate

Indications (1)

Clinical Trials (5)

NCT05316220Phase 3Withdrawn

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
0
Ulcerative Colitis (UC)
NCT02522780Phase 3Completed

Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

Started Feb 2016
276 enrolled
Ulcerative Colitis
NCT02368743N/ACompleted

QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)

Started Dec 2015
117 enrolled
Distal Ulcerative Colitis
NCT02522767Phase 3Completed

Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)

Started Oct 2015
228 enrolled
Ulcerative Colitis
NCT02368717Phase 3Completed

An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase

Started Mar 2015
281 enrolled
Ulcerative Colitis