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Hexaminolevulinate

Generic Name
Hexaminolevulinate
Brand Names
Cysview
Drug Type
Small Molecule
Chemical Formula
C11H21NO3
CAS Number
140898-97-1
Unique Ingredient Identifier
G7H20TKI67
Background

Hexaminolevulinate is an optical imaging drug. In solution form it is instilled intravesically for use with photodynamic blue light cystoscopy as an adjunct to white light cystoscopy. On May 28, 2010, the U.S. Food and Drug Administration (FDA) granted approval for hexaminolevulinate hydrochloride (Cysview for Intravesical Solution, Photocure ASA), as an optical imaging agent for use in combination with the Karl Storz Photodynamic Diagnostic D-Light C (PDD) System for cystoscopic detection of non-muscle invasive papillary cancer of the bladder for patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. Hexaminolevulinate is manufactured under the brand Cysview® by Photocure ASA. In Europe, Hexaminolevulinate is marketed under the brand Hexvix®.

Indication

Hexaminolevulinate is indicated for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy.

Associated Conditions
Bladder Carcinoma, Carcinoma in situ of urinary bladder
Associated Therapies
-

Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection

Phase 3
Recruiting
Conditions
Bladder Cancer
Interventions
Drug: Cysview
Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
First Posted Date
2024-07-29
Last Posted Date
2025-01-10
Lead Sponsor
Johns Hopkins University
Target Recruit Count
200
Registration Number
NCT06525571
Locations
🇺🇸

Sibley Memorial Hospital, Washington, District of Columbia, United States

🇺🇸

Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

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