Drug intelligence / Profile preview

zusduri

Development stage
Approved
Lead developer
UroGen Pharma
Modality
DNA Intercalators/Alkylators → Nucleic Acid-Directed Small Molecules → Small Molecules, Hydrogel Systems → Drug Delivery Systems
Administration
Intravesical
01

Overview

Zusduri is a sustained-release, hydrogel-based formulation of mitomycin designed for intravesical (bladder) administration. It is indicated for the treatment of adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), particularly in patients whose disease has recurred after prior surgical removal. The drug utilizes UroGen’s proprietary RTGel technology to prolong exposure of bladder tissue to mitomycin, enabling local tumor ablation by non-surgical means. Mitomycin acts as an alkylating agent that inhibits DNA synthesis and crosslinks DNA strands, thereby preventing cancer cell growth and division. FDA approval was based on the Phase 3 ENVISION trial showing a 78% complete response rate at three months and durable responses in most patients at one year[1][4][6][8].

Brand names
Zusduri
Other names
mitomycin intravesical solutionUGN-102UGN102UGN 102
02

Targets

DNA

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