Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UGN-104 · 1 trial · 2 indications
CRR is defined as the proportion of patients who achieved CR at the PDE Visit.
| Arm | Type | Description |
|---|---|---|
| UGN-104 | EXPERIMENTAL | Patients will receive UGN-104 once weekly for 6 weeks (a total of 6 doses). The dose of UGN-104 to be instilled is 4 mg mitomycin per 1 mL sterile hydrogel via ureteral catheter (retrograde administration) or nephrostomy tube (antegrade administration). Patients who have a CR at the PDE Visit will enter the Follow-up Period and may receive UGN-104 as maintenance treatment once monthly for 11 months (a total of 11 doses) at the discretion of the investigator. |
| Name | Type | Description |
|---|---|---|
| UGN-104 | DRUG | UGN-104 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-104 allow for local administration of mitomycin as a liquid under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the UUT. |
Inclusion Criteria: 1. Provide written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and protocol. 2. Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system, with the following disease characteristi...
UGN-104 is an investigational small molecule being developed for the treatment of low-grade Upper Urinary Tract Urothelial Carcinoma, a type of cancer affecting the urinary tract. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
UGN-104 targets mitomycin, a chemotherapeutic agent. It is designed to deliver mitomycin directly to the upper urinary tract to treat low-grade Upper Urinary Tract Urothelial Carcinoma. The drug is being studied as a single-arm treatment in an ongoing clinical trial.
UGN-104 is being developed by UroGen Pharma Ltd., a biopharmaceutical company traded on NASDAQ under the ticker symbol URGN. The company is conducting a Phase 3 clinical trial of UGN-104 for the treatment of low-grade Upper Urinary Tract Urothelial Carcinoma.
UGN-104 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 3 trial is currently recruiting participants to evaluate the drug's safety and efficacy.
UGN-104 is being studied in a Phase 3 clinical trial registered as NCT06774131. This single-arm, uncontrolled study is recruiting 70 participants with low-grade Upper Urinary Tract Urothelial Carcinoma across multiple countries, including the United States, Bulgaria, Georgia, Hungary, Israel, Latvia, Poland, Romania, and Spain.
UGN-104 is not the same as mitomycin. Mitomycin is the active chemotherapeutic agent that UGN-104 targets or delivers. UGN-104 is a drug formulation designed to administer mitomycin locally to the upper urinary tract for the treatment of low-grade Upper Urinary Tract Urothelial Carcinoma.