CYSVIEW KIT
Peakhexaminolevulinate hydrochloride
NDAINTRAVESICALFOR SOLUTIONPriority Review
Approved
May 2010
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
3/8 — Basic
Priority Review
CYSVIEW KIT (hexaminolevulinate hydrochloride) is precursor, aminolevulinic acid. First approved in 2010.
Drug data last refreshed 4d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYSVIEW KIT is an intravesical diagnostic agent containing hexaminolevulinate hydrochloride, a precursor to photoactive porphyrins used to enhance visualization of bladder lesions during cystoscopy. After instillation, the drug accumulates preferentially in neoplastic cells and fluoresces red under blue light (360–450 nm), enabling improved detection of tumors compared to white-light cystoscopy. The mechanism relies on differential enzymatic activity in cancer cells that favors porphyrin accumulation.
Peak11.7 years to LOE
The product is in peak commercial phase with patent protection extending to 2038, suggesting stable revenue but limited growth runway for commercial expansion.
Mechanism of Action
precursor, aminolevulinic acid. After bladder instillation, Cysview enters the bladder mucosa and is proposed to enter the intracellular space of mucosal cells where it is used as a precursor in the formation of the photoactive intermediate protoporphyrin IX (PpIX) and other photoactive porphyrins…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
CYSVIEW offers a stable but niche career opportunity in diagnostic oncology with strong patent protection through 2038. Professionals joining this product will focus on maximizing market penetration in urology/oncology settings, managing reimbursement, and supporting clinical adoption of blue-light cystoscopy protocols rather than growth-stage innovation.
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.