Trial Profile

A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in 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: 21 Aug 2026

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At a glance

17 Aug 2026 According to a UroGen Pharma media release, the company announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug UGN-103 (mitomycin) for intravesical solution.
05 Aug 2026 Results presented in UroGen Pharma financial media release.
05 Aug 2026 According to a UroGen Pharma media release, the company remains on track to submit a New Drug Application (NDA) for UGN-103 in the third quarter of 2026, with potential FDA approval in 2027

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