GlobeNewswire·Aug 17, 2026, 8:00 AM ET

UroGen Submits NDA for UGN-103, an Investigational Treatment of Recurrent LG-IR-NMIBC

URGN

UroGen Pharma Ltd. submitted a New Drug Application (NDA) to the FDA on August 17, 2026, for UGN-103 (mitomycin) to treat recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
UGN-103 is a next-generation formulation leveraging RTGel® technology, designed to offer streamlined manufacturing, simplified reconstitution, and an extended shelf-life compared to the existing approved product ZUSDURI.
The NDA is supported by Phase 3 UTOPIA trial data showing a 77.8% three-month complete response rate and a 94.5% six-month duration of response in 99 patients.
These clinical results from the UTOPIA trial align with the efficacy data observed in the pivotal ENVISION trial for ZUSDURI, though no formal cross-trial comparison was conducted.
UroGen holds a licensing agreement with medac, who supplies the lyophilized mitomycin formulation, while UroGen retains U.S. patents covering the RTGel technology combination expected to expire in July 2044.
ZUSDURI remains the first and only FDA-approved treatment for adults with recurrent LG-IR-NMIBC and utilizes a non-surgical intravesical delivery method via urinary catheter.
The UTOPIA trial administered 75 mg of UGN-103 weekly for six weeks in an outpatient setting, with the primary endpoint being the three-month complete response rate.
UroGen Pharma, headquartered in Princeton, NJ, with operations in Israel, continues to focus on developing innovative solutions for urothelial cancers using its proprietary sustained-release hydrogel platform.