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NCT05243550 · ClinicalTrials.gov record · last posted 2026-05-11

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Name: A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer — clinical trial record (NCT05243550)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: ENVISION

StatusActive, Not Recruiting

PhasePhase 3

SponsorUroGen Pharma Ltd.

Started2022-03-01

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

This Phase 3, multinational, single-arm study was designed to evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Amendment record 13 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 13 times since 2022-02-07; most recent amendment 2026-04-24. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2022-12-16

Status change Recruiting→Active, Not Recruitingv7

Trial Details

NCT Number	NCT05243550
Lead Sponsor	UroGen Pharma Ltd.
Conditions	Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
Enrollment	240 participants
Start Date	2022-03-01
Primary Completion	2023-04-26 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2026-05-11