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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

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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 26 May 2025

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At a glance

  • Drugs Mitomycin (Primary)
  • Indications Bladder cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms UTOPIA
  • Sponsors UroGen Pharma

Most Recent Events

  • 12 May 2025 According to a UroGen Pharma media release, enrollment is expected to be completed by mid-2025.
  • 09 Apr 2025 Planned number of patients changed from 87 to 92.
  • 09 Apr 2025 Planned End Date changed from 1 Jul 2026 to 1 Aug 2026.

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