VALSTAR PRESERVATIVE FREE (valrubicin)
Valrubicin treats a specific form of bladder cancer called BCG-refractory carcinoma in situ. This intravesical therapy is used for patients who have not responded to standard BCG treatment and cannot undergo immediate surgery to remove the bladder. It serves as an alternative for those where a surgical procedure would carry an unacceptably high risk of serious illness or death.
How VALSTAR PRESERVATIVE FREE Works
This medication works by disrupting nucleic acid metabolism and causing chromosomal damage that halts the cell cycle. It prevents cells from building new genetic material and uses its metabolites to interfere with topoisomerase II, an enzyme that normally manages the breaking and resealing of DNA.
Details
- Status
- Prescription
- First Approved
- 1998-09-25
- Routes
- INTRAVESICAL
- Dosage Forms
- SOLUTION
VALSTAR PRESERVATIVE FREE Approval History
What VALSTAR PRESERVATIVE FREE Treats
1 indicationsVALSTAR PRESERVATIVE FREE is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Carcinoma In Situ of the Urinary Bladder
VALSTAR PRESERVATIVE FREE 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 VALSTAR PRESERVATIVE FREE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VALSTAR PRESERVATIVE FREE treats. First-in-class if their pivotal trials read out positive.
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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.
VALSTAR PRESERVATIVE FREE FDA Label Details
Indications & Usage
FDA Label (PDF)VALSTAR PRESERVATIVE FREE 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.