Urogen Pharma (UR8) Drug Pipeline
1 Followers
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| 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 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Ugn-104 | Phase III | Urothelial Carcinoma, Upper Urinary Tract Urothelial Carcinoma | Recruiting | A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer | Jan 08, 2025 | ― |
| Ugn-103 | Phase III | Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder | 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 | ― |
| Gemcitabine, Ugn-301, Ugn-201 | Phase I | Bladder Cancer, Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent, Non-Muscle Invasive Bladder Cancer, Nmibc, Carcinoma In Situ Of Bladder | 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 | ― |
| UGN-102 | Phase III | Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder | 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 | ― |
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
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 (DE:UR8) have in its pipeline
Urogen Pharma DE:UR8 is currently developing the following drugs: Ugn-104, Ugn-103, Gemcitabine, Ugn-301, Ugn-201, UGN-102. These drug candidates are in various stages of clinical development as the company works toward FDA approval.
