CYSVIEW KIT (hexaminolevulinate hydrochloride)
Cysview is an optical imaging agent indicated for the cystoscopic detection of bladder cancer, including carcinoma in situ (CIS). It is used in patients with known or suspected lesions based on prior cystoscopy, as well as those undergoing surveillance. Cysview is used as an adjunct to standard white light cystoscopy and must be used specifically with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system. It is not a replacement for random bladder biopsies or other standard diagnostic procedures.
How CYSVIEW KIT Works
Cysview is an ester of the heme precursor aminolevulinic acid. After intravesical instillation, it enters the bladder mucosa and is converted intracellularly into photoactive porphyrins, primarily protoporphyrin IX (PpIX). These compounds accumulate preferentially in neoplastic cells compared to normal urothelium due to altered enzymatic activity. When excited by blue light (wavelengths 360–450 nm), the accumulated porphyrins fluoresce, causing tumors to appear bright red against a dark blue background. Of note, similar accumulation and fluorescence may also occur in inflamed cells, potentially affecting specificity.
Details
- Status
- Prescription
- First Approved
- 2010-05-28
- Patent Cliff
- 2038
- Routes
- INTRAVESICAL
- Dosage Forms
- FOR SOLUTION
CYSVIEW KIT Approval History
What CYSVIEW KIT Treats
2 indicationsCYSVIEW KIT is approved for 2 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bladder Cancer
- Carcinoma In Situ
CYSVIEW KIT Competitive Set
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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 CYSVIEW KIT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CYSVIEW KIT treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to CYSVIEW KIT
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05600322 results posted | PC B309/21 / YHCT-HEX-B1 | Ph 3 | completed | Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer |
| NCT02560584 results posted | PC B308/13 | Ph 3 | completed | A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting |
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.
CYSVIEW KIT FDA Label Details
Indications & Usage
FDA Label (PDF)CYSVIEW KIT is indicated for the treatment of Bladder Cancer; Carcinoma In Situ.
CYSVIEW KIT Patents & Exclusivity
Patents (3 active)
Pro Intelligence Preview
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.