Trial Profile

A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel Formulation of UGN-102, for the Treatment of Patients With Low-grade (LG) Non-muscle Invasive Bladder Cancer (NMIBC) at Intermediate-risk (IR) of Recurrence

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 02 Jun 2026

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At a glance

15 May 2026 According to a UroGen Pharma media release, Based on the consistency of UTOPIA data with the results of the ENVISION trial studying ZUSDURI in patients meeting the same eligibility criteria and alignment with the FDA, UroGen remains on track to submit a New Drug Application (NDA) for UGN-103 in the third quarter of 2026.
15 May 2026 Results presented in the UroGen Pharma Media Release.
06 Nov 2025 Preliminary results presented in an UroGen Pharma media release

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