NDAORALCAPSULE
Approved
Jul 2000
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
4
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 22h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COLAZAL (balsalazide disodium) is an oral small-molecule pro-drug that delivers mesalamine (5-ASA) directly to the colon for treatment of ulcerative colitis. The drug works by releasing mesalamine, which is believed to reduce inflammation by modulating arachidonic acid metabolites in the colonic mucosa. It represents a targeted approach to minimizing systemic exposure while maximizing local therapeutic effect.
$0.197MPart D
LOE Approaching5mo to LOEWith loss of exclusivity imminent (0.4 years remaining), commercial teams face rapid market contraction and consolidation, signaling declining headcount and focus shift to legacy management rather than growth initiatives.
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 (4)
Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg
Started Jan 2007
60 enrolled
Healthy
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
Fasting Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg
Started May 2004
80 enrolled
Healthy
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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.