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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

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: 25 Mar 2026

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At a glance

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

Most Recent Events

  • 27 Feb 2026 According to a UroGen Pharma media release, data from this study will be presented at the 2026 American Society of Clinical Oncology's Genitourinary Cancers Symposium (ASCO-GU 2026).
  • 05 Aug 2025 Results presented in an UroGen Pharma media release.
  • 12 Jun 2025 According to an UroGen Pharma media release, based on data from this study, the U.S. FDA approved ZUSDURI, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC.

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