A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
← catalyst calendarSponsored by UroGen Pharma Ltd. (industry) · URGN — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
99actual
Sites
48
Countries
Bulgaria, Estonia, Georgia +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-08-29 | actual | When the study began enrolling |
| Primary completion | 2025-09-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2024-03-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Bladder Cancer
- Urothelial Carcinoma
- Urothelial Carcinoma Bladder
Intervention
- Drug: UGN-103 — also filed as UGN-103 (mitomycin) for intravesical solution
Primary outcome
what the primary-completion date above is the date OFComplete response rate (CRR)
measured 3 months
Permalink · URGN's whole pipeline · Catalyst calendar · Every registered study · What changed