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UROGEN PHARMA LTD

UROGEN PHARMA LTD logo
🇮🇱Israel
Ownership
Public
Established
2004-01-01
Employees
201
Market Cap
-
Website
http://www.urogen.com

Clinical Trials

19

Active:3
Completed:8

Trial Phases

4 Phases

Phase 1:4
Phase 2:2
Phase 3:7
+1 more phases

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (17 trials with phase data)• Click on a phase to view related trials

Phase 3
7 (41.2%)
Not Applicable
4 (23.5%)
Phase 1
4 (23.5%)
Phase 2
2 (11.8%)

A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer

Phase 3
Not yet recruiting
Conditions
Upper Urinary Tract Urothelial Carcinoma
Urothelial Carcinoma
Interventions
First Posted Date
2025-01-14
Last Posted Date
2025-01-14
Lead Sponsor
UroGen Pharma Ltd.
Target Recruit Count
50
Registration Number
NCT06774131
Locations
🇺🇸

Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States

A Phase 3 Single-arm Study of UGN-103 for the Treatment of LG IR NMIBC.

Phase 3
Active, not recruiting
Conditions
Nonmuscle Invasive Bladder Cancer
First Posted Date
2024-08-14
Last Posted Date
2025-04-23
Lead Sponsor
Urogen Pharma Ltd.
Target Recruit Count
57
Registration Number
2023-507261-25-00
Locations
🇧🇬

University Multiprofessional Hospital For Active Treatment Plovdiv AD, Plovdiv, Bulgaria

🇧🇬

Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD, Gabrovo, Bulgaria

🇧🇬

University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov, Sofiya, Bulgaria

and more 24 locations

uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto

Recruiting
Conditions
Urothelial Carcinoma
Urothelial Carcinoma Ureter Recurrent
Urothelial Carcinoma of the Renal Pelvis and Ureter
Urothelial Carcinoma Recurrent
Urothelial Carcinoma Ureter
Urothelial Cancer of Renal Pelvis
Transitional Cell Carcinoma of Renal Pelvis
Carcinoma, Transitional Cell
Interventions
First Posted Date
2023-05-25
Last Posted Date
2025-02-28
Lead Sponsor
UroGen Pharma Ltd.
Target Recruit Count
400
Registration Number
NCT05874921
Locations
🇺🇸

Providence St. Johns Health Center, Santa Monica, California, United States

🇺🇸

University of Florida, Gainesville, Florida, United States

🇺🇸

Mount Sinai Medical Center of Florida, Inc., Miami, Florida, United States

and more 19 locations

Named Patient Program for Mitomycin for Pyelocalyceal Solution

Conditions
Urothelial Cancer of Renal Pelvis
Urothelial Carcinoma of the Renal Pelvis and Ureter
Urothelial Carcinoma Ureter
Urothelial Carcinoma Ureter Recurrent
Urothelial Carcinoma
Urothelial Carcinoma Recurrent
First Posted Date
2022-08-10
Last Posted Date
2025-02-28
Lead Sponsor
UroGen Pharma Ltd.
Registration Number
NCT05494411

A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)

Phase 1
Active, not recruiting
Conditions
Non-muscle Invasive Bladder Cancer
Interventions
First Posted Date
2024-07-11
Last Posted Date
2025-05-26
Lead Sponsor
Urogen Pharma Ltd.
Target Recruit Count
48
Registration Number
2023-508404-37-00
Locations
🇮🇹

IRCCS Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy

🇮🇹

Ospedale San Raffaele S.r.l., Milan, Italy

🇪🇸

Hospital Universitario Hm Sanchinarro, Madrid, Spain

and more 4 locations
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News

UGN-102 Shows Durable Response in Low-Grade Bladder Cancer Trial

• The ENVISION trial results, published in the _Journal of Urology_, demonstrate an 82.3% duration of response at 12 months in patients treated with UGN-102 who achieved complete response. • UGN-102 showed a 79.6% complete response rate at three months in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). • UroGen's NDA for UGN-102 has been accepted by the FDA, with a PDUFA goal date of June 13, 2025, potentially offering a non-surgical option for LG-IR-NMIBC.

FDA Accepts UroGen's NDA for UGN-102 in Low-Grade Bladder Cancer

The FDA has accepted UroGen's New Drug Application (NDA) for UGN-102 (mitomycin) for intravesical solution, a potential first-in-class treatment.

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