NDAORALCAPSULE
Approved
Jul 2000
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
2
Data completeness
5/8 — Partial
COLAZAL (balsalazide disodium) by Bausch + Lomb is mesalamine, which is the therapeutically active portion of the molecule, and the 4-aminobenzoyl-β-alanine carrier moiety. First approved in 2000.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COLAZAL (balsalazide disodium) is an oral small-molecule 5-aminosalicylic acid (5-ASA) prodrug approved in 2000 for treating ulcerative colitis and inflammatory bowel disease. The drug is cleaved in the colon to release mesalamine, which acts locally on the colonic mucosa to reduce inflammation by inhibiting arachidonic acid metabolites. Balsalazide's carrier moiety is minimally absorbed and largely inert, allowing targeted delivery to the site of disease.
$0.2MPart D
LOE ApproachingDeclining
8mo to LOEMinimal commercial momentum with only $197K in Part D spending in 2023; brand team is likely small and consolidating resources ahead of LOE.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis
Started May 2006
400 enrolled
Inflammatory Bowel DiseaseUlcerative Colitis
New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis
Started Dec 2005
225 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.