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A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
NCT06331299 · View on ClinicalTrials.gov ↗
Study Summary
This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC).
Conditions Studied
Interventions
- DRUG UGN-103
Study Locations (20)
New York
- Great Lakes Physician dba WNYU — Cheektowaga
- AccuMed Research Associates — Garden City
- Crystal Run Healthcare — Middletown
- Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island — New York
California
- Loma Linda University Medical Center — Loma Linda
- Genesis Research, LLC — San Diego
Texas
- Houston Metro Urology (HMU) - Southwest Location — Houston
- Houston Methodist Hospital — Houston
District of Columbia
- The George Washington University Medical Faculty Associates — Washington D.C.
Georgia
- Peachtree Clinical Solutions — Powder Springs
Indiana
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis
Minnesota
- Minnesota Urology - Metro Urology - Woodbury — Woodbury
New Jersey
- Garden State Urology — Morristown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2024-08-29 |
| Est. Completion | 2026-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06331299
The ClinicalTrials.gov registry entry for NCT06331299 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UroGen Pharma, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 1 intervention — of which UGN-103 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06331299 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06331299 about?
NCT06331299 is a clinical study titled "A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer". This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC).
What is the current status of trial NCT06331299?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 99 participants. The study started on 2024-08-29. Estimated completion is 2026-09.
What conditions does trial NCT06331299 study?
This clinical trial studies the following conditions: Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06331299?
The interventions under investigation include: UGN-103 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06331299?
This trial is sponsored by UroGen Pharma, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06331299 being conducted?
This trial has 20 study locations across California, District of Columbia, Georgia, Indiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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