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Urogen Pharma (URGN)
NASDAQ:URGN
Ugn-104
Urothelial Carcinoma, Upper Urinary Tract Urothelial Carcinoma
Phase III
Recruiting
A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer
Jan 08, 2025
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Ugn-103
Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
Phase III
Recruiting
A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
Mar 19, 2024
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Gemcitabine, Ugn-301, Ugn-201
Bladder Cancer, Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent, Non-Muscle Invasive Bladder Cancer, Nmibc, Carcinoma In Situ Of Bladder
Phase I
Active Not Recruiting
A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
May 05, 2022
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UGN-102
Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
Phase III
Active Not Recruiting
A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Feb 07, 2022
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Urogen Pharma (URGN) have in its pipeline
URGN is currently developing the following drugs: Ugn-104, Ugn-103, Gemcitabine, Ugn-301, Ugn-201. These drug candidates are in various stages of clinical development as the company works toward FDA approval.