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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

Blue Light Cystoscopy Reveals Hidden Bladder Tumors, Improves Cancer Staging in Major Registry Study

• New data from a 2,854-patient registry study shows Blue Light Cystoscopy detected additional malignant lesions in 7% of cases that were missed by standard white light examination. • The enhanced detection capabilities led to cancer upstaging in 9.3% of cases, potentially altering treatment decisions regarding intravesical therapy and surgical interventions. • The study revealed 335 additional tumors detected only by Blue Light Cystoscopy, with 43% being carcinoma in-situ and 40% representing high-grade tumors.

Hexvix Receives Marketing Approval in China for Bladder Cancer Detection

• Asieris Pharmaceuticals' partner, Jiangsu Yahong Meditech, has received marketing approval from China's National Medical Products Administration (NMPA) for Hexvix. • Hexvix, used with blue light cystoscopy, enhances the detection of bladder cancer, including carcinoma in situ (CIS), leading to more complete surgical resections. • Chinese and international urological associations recommend hexaminolevulinate (HAL), the active ingredient in Hexvix, as the preferred drug for fluorescence cystoscopy. • The commercialization of Hexvix in China is contingent upon the approval of blue light cystoscopes, including Richard Wolf’s System Blue.

Asieris Pharmaceuticals' Cevira (APL-1702) Shows Promise in HSIL Treatment: Phase III Subgroup Analysis

• Asieris Pharmaceuticals presented Phase III trial subgroup analysis of Cevira (APL-1702) at the 2024 CSCO Annual Meeting, focusing on age-related efficacy in treating cervical HSIL. • The study demonstrated a 15-20% increase in pathological regression rate in the 20-40 age group treated with APL-1702 compared to placebo at six months. • APL-1702 showed enhanced HPV clearance rates in the 20-30 age group, indicating its potential to facilitate regression from HSIL to LSIL and clear high-risk HPV infections. • The new drug application for APL-1702 was accepted by the National Medical Products Administration (NMPA) in May 2024.
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