APRISO

Peak

mesalamine

NDAORALCAPSULE, EXTENDED RELEASE
Approved
Oct 2008
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20

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 (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)
NCT03327558Phase 1Completed

Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects

Started May 2017
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
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
NCT02093663Phase 3Completed

Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis

Started Dec 2014
107 enrolled
Ulcerative Colitis

Loss of Exclusivity

LOE Date
May 1, 2030
50 months away
Patent Expiry
May 1, 2030

Patent Records (1)

Patent #ExpiryTypeUse Code
8865688
May 1, 2030
U-1310