VALRUBICIN
Valrubicin is used for patients with a specific type of bladder cancer known as BCG-refractory carcinoma in situ. This medication is delivered directly into the bladder as an intravesical therapy. It helps patients who cannot undergo an immediate bladder removal surgery due to the high risk of serious complications or death.
How VALRUBICIN Works
This drug works by disrupting nucleic acid metabolism and causing damage to chromosomes within cells. It prevents the incorporation of nucleosides into nucleic acids and stops the cell cycle in the G2 phase. Additionally, its metabolites interfere with the normal breaking and resealing process of DNA topoisomerase II.
Details
- Status
- Prescription
- First Approved
- 2019-04-19
- Routes
- INTRAVESICAL
- Dosage Forms
- SOLUTION
VALRUBICIN Approval History
What VALRUBICIN Treats
1 indicationsVALRUBICIN is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Carcinoma In Situ of the Urinary Bladder
VALRUBICIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 VALRUBICIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VALRUBICIN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to VALRUBICIN
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01606345 | MCC-16722 | Ph 1 | completed | Phase I Study of Percutaneous Valrubicin for Upper Tract Urothelial Carcinoma |
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.
VALRUBICIN FDA Label Details
Indications & Usage
VALRUBICIN is indicated for the treatment of Carcinoma In Situ of the Urinary Bladder.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.