ASACOL

LOE Approaching

mesalamine

NDAORALTABLET, DELAYED RELEASEPriority Review
Approved
Jan 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20

Mechanism of Action

CLINICAL PHARMACOLOGY: Mesalamine is thought to be the major therapeutically active part of the sulfasalazine molecule in the treatment of ulcerative colitis. Sulfasalazine is converted to equimolar amounts of sulfapyridine and mesalamine by bacterial action in the colon. The usual oral dose of…

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
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
NCT02190526Phase 4Withdrawn

Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome

Started Sep 2014