UroGen Pharma Gets FDA Clearance to Begin Phase 1 Trial of UGN-501
UroGen Pharma (URGN) said Wednesday the US Food and Drug Administration cleared its investigational new drug application for UGN-501, allowing the company to begin a phase 1 trial in patients with non-muscle invasive bladder cancer. The company said patient enrollment in the phase 1 study is expected to begin in Q4 2026 and will evaluate the safety, tolerability and feasibility of intravesical administration of UGN-501.
UroGen Pharma (URGN) said Wednesday the US Food and Drug Administration cleared its investigational new drug application for UGN-501, allowing the company to begin a phase 1 trial in patients with non-muscle invasive bladder cancer.
The company said patient enrollment in the phase 1 study is expected to begin in Q4 2026 and will evaluate the safety, tolerability and feasibility of intravesical administration of UGN-501.