UGN-501

Nov. 2, 2026: UroGen Pharma Ltd. (NASDAQ: URGN) announced the first patient was dosed in a Phase 1 trial of UGN-501, an investigational next-generation oncolytic virus for recurrent non-muscle invasive bladder cancer (NMIBC).

The open-label, dose-escalation study will evaluate safety, tolerability, pharmacokinetics, feasibility of intravesical administration, and identify a recommended Phase 2 dose. Eligible adults include patients with recurrent NMIBC, including high-grade Ta/T1 and/or carcinoma in situ, or low-grade Ta/T1 disease. Treatment consists of six once-weekly intravesical instillations during a 12-week induction period. Patients with no evidence of disease at week 12 may receive maintenance treatment of three once-weekly instillations quarterly from month 3 through month 12, with safety follow-up at month 15. The trial is listed as NCT07725796.

The company said UGN-501 is designed to selectively replicate in tumor cells, causing direct tumor cell destruction and anti-tumor immune activation. In parallel with the Phase 1 trial, UroGen is conducting nonclinical studies of an RTGel formulation, but the current Phase 1 uses an aqueous formulation without RTGel.