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# UroGen NDA for UGN-103 Accepted for Review
- URL: https://www.fdaweb.com/urogen-nda-for-ugn-103-accepted-for-review/
- Published: 2026-10-19T15:59:37.000Z
- Updated: 2026-10-19T15:59:37.000Z
- Author: David McFarland
- Tags: Drugs

FDA has accepted for review a UroGen Pharma NDA for investigational drug UGN-103 (mitomycin), an intravesical solution for treating adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The agency has set a user fee review action target date of 6/14/2027.

“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,” the company says.

The NDA is based on clinical data from the ongoing Phase 3 UTOPIA trial, a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in adult patients with recurrent LG-IR-NMIBC. “Treatment with UGN-103 resulted in a 77.8% complete response (CR) rate at three months, and among patients who achieved a CR at three months, the Kaplan-Meier estimated probability of remaining event-free at six months was 94.5%,” the company says.