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News|Articles|October 19, 2026
FDA accepts new drug application for UGN-103 in recurrent LG-IR-NMIBC
Author(s)Hannah Clarke
Fact checked by: Benjamin P. Saylor, Strategic Content Lead
The agency issued a PDUFA target action date of June 14, 2027.
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The FDA has accepted for review a new drug application (NDA) seeking approval of UGN-103 (mitomycin) for intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive
The agency issued a PDUFA target action date of June 14, 2027.
UGN-103 is a next-generation mitomycin formulation that builds on the clinical and commercial foundation of Zusduri (mitomycin) for intravesical solution, which received FDA approval in June 2025.
“FDA acceptance of the UGN-103 NDA advances our vision for the next evolution of our portfolio and our continued commitment to transforming the treatment of recurrent LG-IR-NMIBC,” said Liz Barrett, president and CEO of UroGen, in the news release from the company.1 “Building on our experience with Zusduri (mitomycin) for intravesical solution, UGN-103 combines our proprietary RTGel technology with a novel mitomycin formulation, which leverages a streamlined manufacturing process and simplified reconstitution. We look forward to working closely with the FDA during its review and remain focused on delivering innovative treatment options for people living with this highly recurrent disease.”
Data on UGN-103
The application is supported by data from the phase 3 UTOPIA trial (NCT06331299), which is an ongoing, single-arm, multicenter study evaluating the safety and efficacy of UGN-103 in adult patients with recurrent LG-IR-NMIBC.2 The trial enrolled 99 patients, of whom 97% completed all 6 planned intravesical instillations. Patients received 75 mg of mitomycin once weekly for 6 weeks, with disease status assessed at 3 months using cystoscopy, for-cause biopsy, and urine cytology.
At the 3-month assessment, 77 of 99 patients achieved a CR, corresponding to a rate of 77.8% (95% CI, 68.3 to 85.5). Among patients without a CR, 16% had residual disease and 4% had progression to high-grade disease; 2% had missing or indeterminate responses. Among patients who achieved a CR at 3 months, the 6-month duration of response (DOR) was 94.5% by Kaplan-Meier estimate (95% CI, 86.1 to 97.9).
UroGen noted that these results are consistent with the 79.6% (95% CI, 73.9 to 84.5) CR rate and the 91.9% (95% CI, 86.9 to 95) 6-month DOR observed in the pivotal phase 3 ENVISION trial (NCT05243550), which led to the FDA approval of UGN-102 (mitomycin) for intravesical solution (Zusduri) in June 2025 for recurrent LG-IR-NMIBC.3,4
Safety data on UGN-103 were based on the 99 patients who received at least 1 dose of treatment. Treatment-emergent adverse events (TEAEs) occurred in 60% of patients, with the most common being dysuria (19%). Two patients experienced a total of 3 serious TEAEs—atrial fibrillation, osteoarthritis, and respiratory failure—and none were considered treatment related. No TEAE resulted in death.
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REFERENCES
1. UroGen announces FDA acceptance of the New Drug Application for UGN-103, an investigational treatment for adults with recurrent LG-IR-NMIBC. News release. UroGen. October 19, 2026. Accessed October 19, 2026.
2. Srivastava A, Vjaters E, Kaimakliotis HZ, et al. UTOPIA: A phase 3 trial of UGN-103, an intravesical mitomycin reverse thermal hydrogel, in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. J Clin Oncol. 2026;44 (suppl 16). doi:10.1200/JCO.2026.44.16_suppl.4604
3. Prasad SM, Mihaylov NV, Khuskivadze A, et al. Duration of response (DoR) following treatment with UGN-102 in patients with recurrent, low-grade, intermediate-risk, non-muscle invasive, bladder cancer: 18-month DoR data from the phase 3 ENVISION trial. J Clin Oncol. 2025;43 (suppl 16). https://doi.org/10.1200/JCO.2025.43.16_suppl.4598
4. UroGen reports 94.5% six-month duration of response in phase 3 UTOPIA trial, advancing UGN-103 toward potential approval in recurrent low-grade intermediate-risk NMIBC. News release. UroGen Pharma. May 15, 2026. Accessed August 17, 2026.
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