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NCT06774131 · ClinicalTrials.gov record · last posted 2026-06-16

A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer

StatusRecruiting
PhasePhase 3
Started2025-08-06
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO \[mitomycin\] for pyelocalyceal solution), instilled in the upper urinary tract (UUT) of patients with low-grade upper tract urothelial cancer (LG-UTUC).

Protocol amendment history 4 changes detected by DataLookout

2026-06-17
Trial sites expanded: 52 → 62 locations
2026-04-30
Trial sites expanded: 42 → 52 locations
2026-04-30
Primary completion pushed: 2026-10 → 2027-03
2026-04-30
Completion pushed: 2027-10 → 2028-03
Trial Details
NCT Number NCT06774131
Lead Sponsor UroGen Pharma Ltd.
Conditions Upper Urinary Tract Urothelial Carcinoma, Urothelial Carcinoma
Enrollment 70 participants
Start Date 2025-08-06
Primary Completion 2027-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-16