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NCT06331299 · ClinicalTrials.gov record · last posted 2026-01-15

A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer

Name: A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer — clinical trial record (NCT06331299)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: UTOPIA

StatusActive, Not Recruiting

PhasePhase 3

SponsorUroGen Pharma Ltd.

Started2024-08-29

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC).

Amendment record 8 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 8 times since 2024-03-19; most recent amendment 2026-01-13. 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 ↗

2026-01-13

Status change Recruiting→Active, Not Recruitingv8

2024-08-15

Status change Not Yet Recruiting→Recruitingv3

Trial Details

NCT Number	NCT06331299
Lead Sponsor	UroGen Pharma Ltd.
Conditions	Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
Enrollment	99 participants
Start Date	2024-08-29
Primary Completion	2025-09-11 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2026-01-15