Drug intelligence / Profile preview

mitomycin c + TC-3 gel

Development stage
Approved
Lead developer
UroGen Pharma
Modality
Hydrogel Systems → Drug Delivery Systems, Small Molecules
Administration
Upper Tract Instillation, Intravesical
01

Overview

Mitomycin c + TC-3 gel is a combination product comprising the antineoplastic antibiotic **mitomycin c** and a proprietary thermoreversible, reverse-thermal hydrogel delivery system called **TC-3 gel**. The gel is liquid at low temperatures and solidifies at body temperature, enabling prolonged local release of mitomycin c when instilled in the urinary tract. This formulation is designed to increase exposure of mitomycin c to urothelial tissues, particularly for use in low-grade upper tract urothelial cancer (UTUC), addressing areas inaccessible or poorly responsive to traditional therapies. The product, under names such as **JELMYTO** or **MitoGel**, received FDA approval based on studies demonstrating significant and durable clinical responses in patients with low-grade UTUC. Mitomycin c acts as an alkylating agent, cross-linking DNA strands and inhibiting DNA synthesis, leading to apoptosis of cancer cells. TC-3 gel is a non-active carrier with no direct pharmacological effect, but crucial for local drug delivery and sustained release[3][6][7][9].

Brand names
JELMYTOMitoGel
Other names
mitomycin gelmitomycin c + hydrogelmitomycin c + TC-3 gelmitomycin formulation with TC-3 gel
02

Targets

DNA

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