Princeton, New Jersey — August 17, 2026
UroGen Pharma Ltd. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UGN-103 (mitomycin) for intravesical solution, an investigational next-generation formulation being developed for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The regulatory submission represents an important development milestone for UroGen as the company seeks to expand its portfolio of localized treatments for urothelial cancers. UGN-103 is designed to build on the clinical and commercial foundation of ZUSDURI (mitomycin) for intravesical solution, while incorporating formulation and manufacturing improvements intended to streamline preparation, simplify reconstitution and extend the shelf life of the reconstituted product. The NDA is supported by data from the ongoing Phase 3 UTOPIA trial, positioning UGN-103 for potential regulatory review in a patient population where recurrent bladder tumors can require repeated interventions.
UGN-103 NDA Supported by Phase 3 UTOPIA Data
The UGN-103 NDA submission is supported by clinical findings from the Phase 3 UTOPIA trial, a multicenter, single-arm study evaluating the efficacy and safety of the investigational treatment in adults with recurrent LG-IR-NMIBC. The study enrolled 99 patients across global sites, with participants receiving 75 mg of UGN-103 through intravesical instillation once weekly for six weeks in an outpatient setting. The primary endpoint is the complete response rate at three months, with patients achieving a response entering follow-up for assessment of duration of response. In the reported results, UGN-103 demonstrated a 77.8% three-month complete response rate, with a 95% confidence interval of 68.3% to 85.5%. The company also reported a 94.5% six-month duration of response based on Kaplan-Meier estimation. UroGen noted that these outcomes were consistent with results observed in the pivotal ENVISION trial of ZUSDURI, while emphasizing that the studies were separate and no formal cross-trial comparison was performed.
RTGel Technology Supports Localized Bladder Treatment
A key element of UGN-103 is UroGen’s proprietary RTGel® technology, a reverse-thermal hydrogel platform designed to provide sustained exposure of medication within the bladder. UGN-103 combines this technology with a licensed lyophilized mitomycin formulation from medac, with the goal of maintaining the therapeutic foundation of ZUSDURI while improving practical aspects of product preparation and use. The treatment is administered directly into the bladder through a urinary catheter by a trained healthcare professional in an outpatient setting, providing a non-surgical local treatment approach for bladder tumors. UroGen holds U.S. patents covering the combination of its RTGel technology with the licensed mitomycin formulation and the use of UGN-103 in LG-IR-NMIBC, with intellectual property protection expected to extend into July 2044. If approved, UGN-103 could therefore strengthen UroGen’s position in localized bladder cancer treatment while providing an updated formulation designed around clinical and commercial usability.
Advertisement
Artelo Strengthens Long-Term Development Strategy
The NDA comes against a significant clinical need in non-muscle invasive bladder cancer, where recurrence remains common and patients can face repeated procedures over the course of their disease. UroGen estimates that approximately 82,000 people in the United States are affected by LG-IR-NMIBC each year, including an estimated 59,000 experiencing recurrence. Current management commonly involves transurethral resection of bladder tumor (TURBT), and up to 70% of NMIBC patients experience at least one recurrence. UGN-103 is intended to provide another localized treatment option while leveraging a sustained-release formulation that delivers mitomycin directly within the bladder. The NDA submission now moves the program into the FDA regulatory review process, although submission does not guarantee approval. The regulatory outcome will depend on the FDA’s assessment of the clinical, manufacturing and other supporting data included in the application. UGN-103 nevertheless represents a significant pipeline milestone for UroGen as the company seeks to advance next-generation treatment options for recurrent bladder cancer.
Source: UroGen Pharma press relese
