BALSALAZIDE DISODIUM

Post-LOE

balsalazide disodium

Hikma

ANDAORALTABLET

Approved

Sep 2015

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

BALSALAZIDE DISODIUM (balsalazide disodium) by Hikma is mesalamine, which is the therapeutically active portion of the molecule, and the 4-aminobenzoyl-β-alanine carrier moiety. Approved for mildly to moderately active ulcerative colitis in patients 5 years of age, older, ulcerative colitis. First approved in 2015.

Drug data last refreshed 18h ago

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Mechanism of Action

mesalamine, which is the therapeutically active portion of the molecule, and the 4-aminobenzoyl-β-alanine carrier moiety. The carrier moiety released when balsalazide disodium is cleaved is only minimally absorbed and is largely inert. The mechanism of action of 5-ASA is unknown, but appears to be…

Indications (3)

mildly to moderately active ulcerative colitis in patients 5 years of age older

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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.

Clinical Trials (2)

NCT00408174Phase 3Completed

Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis

Started May 2006

400 enrolled

Inflammatory Bowel DiseaseUlcerative Colitis

NCT00269438Phase 3Completed

New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis

Started Dec 2005

225 enrolled

Ulcerative Colitis