UroGen Announces First Patient Dosed in Phase 1 Trial of UGN-501, an Investigational Next-Generation Oncolytic Virus for Non-Muscle Invasive Bladder Cancer
Key Highlights
- ➤UGN-501 first patient dosed in Phase 1 NMIBC trial
- ➤Phase 1 evaluates safety, tolerability, pharmacokinetics and recommended Phase 2 dose
- ➤Trial uses six once-weekly intravesical instillations during 12-week induction
- ➤UroGen is separately studying UGN-501 formulation with proprietary RTGel technology
Expert Statements
Mark Schoenberg, M.D., Chief Medical Officer of UroGen
“The first patient dosed with UGN-501 marks an important step in advancing this investigational therapy from nonclinical research into clinical evaluation”
Mark Schoenberg, M.D., Chief Medical Officer of UroGen
“We can now begin to understand its safety and tolerability in patients with NMIBC and generate insights to guide its continued development”
Mark Schoenberg, M.D., Chief Medical Officer of UroGen
“This progress brings us closer to our goal of expanding treatment options for patients with bladder cancer”
* Phase 1 clinical trial to evaluate local intravesical administration of UGN-501 * UGN-501 is a differentiated investigational next-generation oncolytic virus designed to combine direct tumor cell destruction with anti-tumor immune activation PRINCETON, N.J., Nov. 02, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the first patient was dosed with UGN-501, a next-generation investigational oncolytic virus. The Phase 1 trial will evaluate the safety, tolerability, and feasibility of intravesical administration of UGN-501.
“The first patient dosed with UGN-501 marks an important step in advancing this investigational therapy from nonclinical research into clinical evaluation,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “We can now begin to understand its safety and tolerability in patients with NMIBC and generate insights to guide its continued development. This progress brings us closer to our goal of expanding treatment options for patients with bladder cancer.”
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