Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as UGN-103 (mitomycin) for intravesical solution
UGN-103 · 1 trial · 3 indications
CRR is defined as the proportion of patients who achieved a complete response (CR) at the 3-month Visit. A patient was considered a CR if there was no detectable disease in the bladder based on visual observation (white light cystoscopy), biopsy of remaining lesions (if applicable), and voiding urine cytology.
| Arm | Type | Description |
|---|---|---|
| UGN-103 | EXPERIMENTAL | Patients received 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 being developed for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer, a form of urothelial carcinoma confined to the bladder lining. It is an investigational small molecule formulated for local administration into the bladder, studied in adults aged 18 years and older.
UGN-103 is developed by UroGen Pharma Ltd., a biopharmaceutical company that trades on the Nasdaq under the ticker URGN. UroGen specializes in therapies delivered locally to the urinary tract, and UGN-103 is part of its bladder cancer pipeline.
UGN-103 is in Phase 3 clinical development for low-grade intermediate-risk non-muscle invasive bladder cancer. It is investigational and has not been approved by the FDA for any indication. The Phase 3 study evaluating it has completed enrollment and follow-up.
UGN-103 was evaluated in the Phase 3 trial NCT06331299, titled A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer. The completed study enrolled 99 patients across the United States, Bulgaria, Estonia, Georgia, Latvia, Romania, and Spain.
The Phase 3 trial NCT06331299 was an uncontrolled, single-group study without randomization or blinding, enrolling 99 adults aged 18 years and older of all sexes. It did not select patients by biomarker and excluded healthy volunteers, focusing only on patients with low-grade intermediate-risk non-muscle invasive bladder cancer.