A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC

This study is being conducted to evaluate the safety and tolerability of UGN-501 administered intravesically in adult participants with recurrent non-muscle invasive bladder cancer (NMIBC) and to determine the recommended Phase 2 dose (RP2D).

NCT Number	NCT07725796
Lead Sponsor	UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.
Conditions	Bladder (Urothelial, Transitional Cell) Cancer, NMIBC, Urothelial Carcinoma Bladder, Urothelial Carcinoma in Situ, Urothelial Carcinoma Recurrent, Urothelial Carcinoma of the Urinary Bladder, Non-Muscle Invasive Bladder Carcinoma, Non-muscle Invasive Bladder Cancer (NMIBC)
Enrollment	30 participants
Start Date	2026-09-30
Primary Completion	2029-08-02 (estimated)
Study Completion	2029-08-02 (estimated)
Updated on ClinicalTrials.gov	2026-07-24