DIPENTUM (olsalazine sodium)
Dipentum helps adult patients with ulcerative colitis maintain their state of remission. It is specifically used for individuals who are unable to tolerate sulfasalazine. This medication provides a long-term management option to keep the disease stable in the colon.
How DIPENTUM Works
After reaching the colon, bacteria convert this drug into 5-aminosalicylic acid (5-ASA), which works by exerting a topical anti-inflammatory effect on colonic epithelial cells. It likely reduces inflammation by blocking cyclooxygenase and inhibiting the production of prostaglandins and other arachidonic acid metabolites.
Details
- Status
- Prescription
- First Approved
- 1990-07-31
- Routes
- ORAL
- Dosage Forms
- CAPSULE
DIPENTUM Approval History
What DIPENTUM Treats
1 indicationsDIPENTUM is approved for 1 conditions since its original approval in 1990. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ulcerative Colitis
DIPENTUM 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 DIPENTUM's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DIPENTUM treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DIPENTUM
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.
DIPENTUM FDA Label Details
Indications & Usage
FDA Label (PDF)DIPENTUM is indicated for the treatment of Ulcerative Colitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.