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

ClinicalTrials.gov ID: NCT06331299

Public ClinicalTrials.gov record NCT06331299. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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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

Study identification

NCT ID: NCT06331299
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: UroGen Pharma Ltd.; Industry
Enrollment: 99 participants

Conditions and interventions

Conditions

Interventions

UGN-103 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 28, 2024
Primary completion: Sep 10, 2025
Completion: Aug 31, 2026
Last update posted: Jan 14, 2026

2024 – 2026

United States locations

U.S. sites: 17
U.S. states: 11
U.S. cities: 15

Facility	City	State	ZIP	Site status
Loma Linda University Medical Center	Loma Linda	California	92354	—
Genesis Research, LLC	San Diego	California	92123	—
The George Washington University Medical Faculty Associates	Washington D.C.	District of Columbia	20037	—
Peachtree Clinical Solutions	Powder Springs	Georgia	30127	—
Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	46202	—
Minnesota Urology - Metro Urology - Woodbury	Woodbury	Minnesota	55125	—
Garden State Urology	Morristown	New Jersey	07962	—
Great Lakes Physician dba WNYU	Cheektowaga	New York	14225	—
AccuMed Research Associates	Garden City	New York	11530	—
Crystal Run Healthcare	Middletown	New York	10941	—
Laura and Isaac Perlmutter Cancer Center at NYU Langone	New York	New York	10016	—
Perlmutter Cancer Center at NYU Langone Hospital - Long Island	New York	New York	11501	—
Carolina Urologic Research Center	Myrtle Beach	South Carolina	29572	—
Urology Associates P.C. - Nashville	Nashville	Tennessee	37209-4035	—
Houston Metro Urology (HMU) - Southwest Location	Houston	Texas	77027	—
Houston Methodist Hospital	Houston	Texas	77030	—
Spokane Urology, P.S.	Spokane	Washington	99202	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06331299, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 14, 2026 · Synced May 20, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06331299 live on ClinicalTrials.gov.

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