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Completed Phase 3 Interventional Results available

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.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 10:13 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This Phase 3, single-arm, multicenter study was designed to evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Study identification

NCT ID
NCT06331299
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
UroGen Pharma Ltd.
Industry
Enrollment
99 participants

Conditions and interventions

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 29, 2024 (Actual)
Primary completion
Sep 11, 2025 (Actual)
Completion
Sep 15, 2026 (Actual)
Last update posted
Oct 22, 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 Oct 22, 2026 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06331299 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →