COLAZAL (balsalazide disodium)
Colazal helps patients five years of age and older who are experiencing mildly to moderately active ulcerative colitis. This medication is used to manage inflammation in the colon during active flares. Because long-term data is limited, it is typically prescribed for short durations, generally up to eight weeks for children and twelve weeks for adults.
How COLAZAL Works
The drug works by traveling intact to the colon, where it is broken down by bacteria to release mesalamine, the active component. Once released, mesalamine exerts a local anti-inflammatory effect on colonic cells, likely by blocking the production of substances that drive inflammation in the gut.
Details
- Status
- Prescription
- First Approved
- 2000-07-18
- Patent Cliff
- 2027
- Routes
- ORAL
- Dosage Forms
- CAPSULE
COLAZAL Approval History
What COLAZAL Treats
1 indicationsCOLAZAL is approved for 1 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ulcerative Colitis
COLAZAL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in COLAZAL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications COLAZAL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to COLAZAL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
COLAZAL FDA Label Details
Indications & Usage
FDA Label (PDF)COLAZAL is indicated for the treatment of Ulcerative Colitis.
COLAZAL Patents & Exclusivity
Patents (4 active)
Pro Intelligence Preview
Deep insights for COLAZAL
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 4 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.