# A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer

Source: https://onco.cc/trials/nct06331299/  
OnCo record `nct06331299` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing UGN-103 in bladder & urothelial cancer, active and no longer recruiting.

## Summary

A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer is a phase 3 interventional study registered as NCT06331299, led by UroGen Pharma, and active but no longer recruiting on the registry. Official title: A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel Formulation of UGN-102, for the Treatment of Patients With Low-grade (LG) Non-muscle Invasive Bladder Cancer (NMIBC) at Intermediate-risk (IR) of Recurrence. Planned enrolment is 99 participants (actual). The study started in 2024-08-29 and primary completion is expected in 2025-09-11. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-11
- Also known as: UTOPIA
- Tags: ctgov-ingest
- Registry id: NCT06331299
- Phase: 3
- Setting: A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel Formulation of UGN-102, for the Treatment of Patients With Low-grade (LG) Non-muscle Invasive Bladder Cancer (NMIBC) at Intermediate-risk (IR) of Recurrence
- Sponsor: UroGen Pharma
- Enrolled: 99

## Sources

- ClinicalTrials.gov NCT06331299: https://clinicaltrials.gov/study/NCT06331299

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Non-muscle-invasive bladder cancer](https://onco.cc/cancers/non-muscle-invasive-bladder-cancer/)
- drugs: [UGN-103](https://onco.cc/drugs/ugn-103/)
- companies: [UroGen Pharma](https://onco.cc/companies/urogen-pharma/)

---
JSON: https://onco.cc/api/v1/entities/nct06331299.json