UGN-102 FDA Approval Status
Last updated by Judith Stewart, BPharm on Oct 30, 2024.
FDA Approved: No
Brand name: UGN-102
Generic name: mitomycin
Dosage form: for Intravesical Solution
Company: UroGen Pharma Ltd.
Treatment for: Bladder Cancer
UGN-102 (mitomycin) for intravesical solution is a sustained release, hydrogel-based formulation of mitomycin in development for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
- UGN-102 utilizes UroGen’s proprietary RTGel® technology to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means.
- UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional.
- A New Drug Application (NDA) for UGN-102 is currently under review by the FDA with a potential decision expected by June 13, 2025.
Development timeline for UGN-102
Further information
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