Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UGN-103 · 1 trial · 3 indications
CRR is defined as the proportion of patients who achieved CR at the 3-month Visit.
| Arm | Type | Description |
|---|---|---|
| UGN-103 | EXPERIMENTAL | Patients will receive UGN-103 (75 mg mitomycin) once weekly for 6 weeks (a total of 6 doses). |
| Name | Type | Description |
|---|---|---|
| UGN-103 | DRUG | UGN-103 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-103 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 bladder. |
Inclusion Criteria: 1. Provide written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol. 2. Patient who has LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Sc...
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UGN-103 is an investigational small molecule being developed for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer, a form of bladder cancer and urothelial carcinoma. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
UGN-103 is a small molecule therapeutic, but its specific molecular target has not been disclosed. The drug is being studied for its potential to treat low-grade intermediate-risk non-muscle invasive bladder cancer, though the exact mechanism of action is not publicly detailed.
UGN-103 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 to evaluate the drug in patients with low-grade intermediate-risk non-muscle invasive bladder cancer.
UGN-103 is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The ongoing Phase 3 study is active but not recruiting participants, and it is designed to assess the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer.
UGN-103 is being evaluated in a single Phase 3 clinical trial registered as NCT06331299. This active, non-recruiting study has an enrollment target of 99 participants and is being conducted in the United States, Bulgaria, Estonia, Georgia, Latvia, Romania, and Spain. The trial is not randomized, double-blind, or controlled.