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Drug intelligence / Profile preview
gemcitabine-releasing intravesical system
- Development stage
- Phase 3
- Lead developer
- Johnson & Johnson
- 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 familyPOLG (Mitochondrial DNA polymerase gamma)RNR (Ribonucleotide reductase)
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