Drug intelligence / Profile preview

gemcitabine-releasing intravesical system

Development stage
Phase 3
Lead developer
Janssen Biotech
Modality
Small Molecules
Administration
Intravesical
01

Overview

A controlled-release, drug-device combination product designed to deliver gemcitabine directly into the bladder over an extended period. The system consists of a small, flexible tube-like device with a solid core of gemcitabine, a broad-spectrum antimetabolite and deoxycytidine analogue with antitumor activity. After placement in the bladder, it provides sustained local release of gemcitabine for up to 7 days. The mechanism involves cellular uptake of gemcitabine via nucleoside transporters; intracellular phosphorylation produces active metabolites that inhibit DNA synthesis and ribonucleotide reductase, leading to apoptosis in cancer cells. Developed primarily for high-risk non-muscle invasive bladder cancer (NMIBC), especially in patients unresponsive to BCG therapy[1][2][3][4][5][6].

Brand names
GemRIS
Other names
gemcitabine-releasing intravesical systemTARIS (as in "Gemcitabine-releasing intravesical system - TARIS")
02

Targets

DNA polymerase familyRNR (Ribonucleotide reductase)POLG (Mitochondrial DNA polymerase gamma)

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