BALSALAZIDE DISODIUM
Balsalazide disodium treats mildly to moderately active ulcerative colitis in adults and children five years of age and older. It helps patients manage active symptoms, though its use is typically limited to short-term periods of eight weeks for children and twelve weeks for adults. This medication is used to provide a local anti-inflammatory effect directly within the colon.
How BALSALAZIDE DISODIUM Works
This drug works by traveling intact to the colon, where it is broken down by bacteria to release mesalamine, the active therapeutic component. Once released, mesalamine provides a local anti-inflammatory effect on colonic cells, likely by blocking the production of specific metabolites that drive inflammation.
Details
- Status
- Prescription
- First Approved
- 2007-12-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
BALSALAZIDE DISODIUM Approval History
What BALSALAZIDE DISODIUM Treats
1 indicationsBALSALAZIDE DISODIUM is approved for 1 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ulcerative Colitis
BALSALAZIDE DISODIUM 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 BALSALAZIDE DISODIUM's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BALSALAZIDE DISODIUM treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BALSALAZIDE DISODIUM
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.
BALSALAZIDE DISODIUM FDA Label Details
Indications & Usage
BALSALAZIDE DISODIUM is indicated for the treatment of Ulcerative Colitis.
Looking for the branded version?
COLAZAL
Full clinical data, patents, trials, and competitive landscape for balsalazide disodium.
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.