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Active, not recruiting Phase 3 Interventional Results available

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

ClinicalTrials.gov ID: NCT05243550

Public ClinicalTrials.gov record NCT05243550. 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 22, 2026, 9:31 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-102 as Primary Chemoablative Therapy in 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, multinational, single-arm study was designed to evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Study identification

NCT ID
NCT05243550
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
UroGen Pharma Ltd.
Industry
Enrollment
240 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
Mar 1, 2022 (Actual)
Primary completion
Apr 26, 2023 (Actual)
Completion
Mar 2028 (Estimated)
Last update posted
May 11, 2026

2022 – 2028

United States locations

U.S. sites
16
U.S. states
10
U.S. cities
14
Facility City State ZIP Site status
Arizona Urology Specialists Tucson Arizona 85704 —
Loma Linda University Medical Center Loma Linda California 92350 —
Genesis Research San Diego California 92123 —
Wichita Urology Group Wichita Kansas 67226 —
John Hopkins University Baltimore Maryland 21218 —
Chesapeake Urology Research Associates Hanover Maryland 21076 —
University of Missouri Columbia Missouri 65212 —
Atlantic Health System Morristown New Jersey 07960 —
Great Lakes Physician dba WNY Urology Associates Cheektowaga New York 14225 —
AccuMed Research Associates Garden City New York 11530 —
Manhattan Medical Research New York New York 10016 —
NYU Langone Health New York New York 10016 —
Mount Sinai New York New York 10029 —
Urology Associates, P.C. Nashville Tennessee 37209 —
Houston Methodist Research Institute 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 49 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05243550, 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 May 11, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05243550 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →