UroGen Pharma completes enrollment in Phase 3 UTOPIA trial of UGN-103

UroGen Pharma (URGN) has completed patient enrollment in its Phase 3 UTOPIA clinical trial of UGN-103 for intravesical solution, a next-generation formulation in development for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The UTOPIA trial enrolled 99 patients across multiple centers globally. UGN-103 uses UroGen’s proprietary sustained release RTGel technology, a reverse-thermal hydrogel that enables sustained drug release and prolonged bladder exposure. UGN-103 is designed to offer improvements over ZUSDURI for intravesical solution, including a shorter manufacturing process and simplified reconstitution procedure. The UTOPIA trial is a single-arm, multicenter study evaluating the efficacy and safety of UGN-103. All enrolled patients receive 75 mg of UGN-103 via intravesical instillation once weekly for six weeks. The primary endpoint is complete response rate at three months, with responders entering a follow-up phase of up to 12 months to assess durability of response.