PRINCETON, N.J., May 15, 2026
UroGen Pharma Ltd. announced positive six-month results from the ongoing Phase 3 UTOPIA trial, showing that UGN-103 (mitomycin) for intravesical solution achieved a 94.5% durability of response (DOR) in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The data further strengthen UGN-103’s potential path toward regulatory approval and position the therapy as a promising advancement in the treatment of recurrent bladder cancer.
According to the company, the six-month DOR results were generally consistent with outcomes observed in the pivotal ENVISION trial of ZUSDURI™, the first and only FDA-approved treatment for adults with recurrent LG-IR-NMIBC. UroGen confirmed that, following alignment discussions with the U.S. Food and Drug Administration (FDA), the company remains on track to submit a New Drug Application (NDA) for UGN-103 in the third quarter of 2026.
UGN-103 Demonstrates Durable Clinical Response
The ongoing Phase 3 UTOPIA study is evaluating UGN-103 in 99 patients treated with once-weekly intravesical instillations over six weeks in an outpatient setting. Patients achieving complete response entered a long-term follow-up period to evaluate durability through 12 months.
The newly reported data demonstrated a 94.5% six-month durability of response, reinforcing confidence in the therapy’s long-term disease control potential. Investigators stated that the results support UGN-103’s ability to build upon the clinical success of ZUSDURI while introducing manufacturing and administration improvements designed to simplify treatment delivery in clinical practice.
UGN-103 utilizes UroGen’s proprietary RTGel® sustained-release technology, which enables prolonged exposure of mitomycin directly at tumor sites within the bladder. The company highlighted that the investigational therapy features a more streamlined manufacturing process and simplified reconstitution compared with previous formulations, while maintaining the core therapeutic benefits of RTGel technology.
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FDA Filing Remains on Track for 2026
Lead investigator Dr. Abishek Srivastava stated that the durability findings underscore UGN-103’s potential to further improve treatment options for patients with recurrent low-grade bladder cancer. Company executives added that the therapy could become a new standard of care in the uro-oncology market if approved.
UroGen also emphasized the long-term commercial opportunity associated with UGN-103, supported by intellectual property protection expected to extend through December 2041. The company believes the therapy could strengthen its position in the growing bladder cancer treatment market while expanding its uro-oncology portfolio.
Non-muscle invasive bladder cancer remains one of the most recurrent forms of cancer worldwide, often requiring repeated surgeries and ongoing surveillance. The development of durable, minimally invasive intravesical therapies such as UGN-103 represents a significant focus area for improving patient outcomes while reducing treatment burden.
Source: UroGen Pharma press release
