UroGen Pharma Ltd. Announces Completion of Enrollment in the Phase 3 UTOPIA Clinical Trial of UGN-103 for the Treatment of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Published: 2025-07-07 08:50:39 ET URGN

Published on 07/07/2025 at 08:50

UroGen Pharma Ltd. announced that it has completed patient enrollment in its Phase 3 UTOPIA clinical trial of UGN-103 (mitomycin) for intravesical solution, a next-generation formulation in development for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The UTOPIA trial enrolled 99 patients across multiple centers globally. UGN-103 uses UroGen's proprietary sustained release RTGel®?

technology, a reverse-thermal hydrogel that enables sustained drug release and prolonged bladder exposure. UroGen-103 is designed to offer improvements over ZUSDURI?? (mitomycin) for intervesical solution, including a shorter manufacturing process and simplified reconstitution procedure.

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen's proprietary RTGel®? Technology, a sustained release, hydrogel-based formulation, ZUSDURI is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means.

ZUSDURI is expected to be available in the U.S. on or around July 1, 2025.