UGN-104

UGN-104 is a chemotherapy (mitomycin) delivered via hydrogel developed by UroGen Pharma. Its molecular target is not stated in the ClinicalTrials.gov intervention record, and OnCo has not confirmed one from the sponsor's pipeline page. The sponsor states: Combines RTGel technology with medac's mitomycin formulation for kidney-sparing treatment of low-grade upper tract urothelial cancer; currently in a Phase 3 study. ClinicalTrials.gov describes the intervention as: UGN-104 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-104 allow for local administration of mitomycin as. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT06774131 (A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer), in bladder & urothelial cancer. The largest, NCT06774131, plans to enrol 70 participants with primary completion expected 2027-03. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.