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HEXAMINOLEVULINATE
HEXAMINOLEVULINATE is a drug. It is currently FDA-approved (first approved 2010).
Cysview is converted into PpIX and PAPs, which accumulate in neoplastic cells and fluoresce under specific light, aiding cystoscopic detection.
At a glance
| Generic name | HEXAMINOLEVULINATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2010 |
Mechanism of action
Cysview, when instilled in the bladder, is taken up by mucosal cells and converted into PpIX and PAPs. These compounds accumulate more in cancerous cells than in normal cells, and when exposed to light, they emit a red fluorescence that helps identify tumors during cystoscopy.
Approved indications
Common side effects
- Bladder spasm
- Dysuria
- Hematuria
- Bladder pain
Serious adverse events
- Anaphylaxis
- Anaphylactoid shock
- Hypersensitivity reactions
- Cystitis
- Abnormal urinalysis
Key clinical trials
- Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) (PHASE4)
- Blue Light Cystoscopy With Cysview® Registry
- Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection (PHASE3)
- Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer (PHASE3)
- The Impact of PDD During TURB for NMIBC (PHASE4)
- Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT (PHASE2, PHASE3)
- Validation of Endoscopic Bimodal Imager for the Bladder Cancer Detection (NA)
- The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- HEXAMINOLEVULINATE CI brief — competitive landscape report
- HEXAMINOLEVULINATE updates RSS · CI watch RSS
Frequently asked questions about HEXAMINOLEVULINATE
What is HEXAMINOLEVULINATE?
How does HEXAMINOLEVULINATE work?
When was HEXAMINOLEVULINATE approved?
What development phase is HEXAMINOLEVULINATE in?
What are the side effects of HEXAMINOLEVULINATE?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing