Zusduri FDA Approval History
Last updated by Judith Stewart, BPharm on June 13, 2025.
FDA Approved: Yes (First approved June 12, 2025)
Brand name: Zusduri
Generic name: mitomycin
Dosage form: for Intravesical Solution
Previous Name: UGN-102
Company: UroGen Pharma Ltd.
Treatment for: Bladder Cancer
Zusduri (mitomycin) is a sustained release, hydrogel-based formulation of mitomycin for intravesical treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
- Non-muscle invasive bladder (NMIBC) cancer is cancer that is located only in the urothelium (inner layer of the bladder). Low-grade intermediate-risk NMIBC (LG-IR-NMIBC) means the cancer cells are slow growing with an intermediate-risk of spreading (risk determined by stage, grade, size, and number of tumors present).
- Zusduri contains mitomycin, an antineoplastic antibiotic first approved over forty years ago for intravenous use in the treatment of certain types of cancer, then more recently for administration directly into the bladder for the treatment of bladder cancer. UroGen's Jelmyto (mitomycin) for pyelocalyceal solution was approved in 2020 for the treatment of low-grade upper tract urothelial cancer (LG UTUC). Mitomycin is an alkylating agent that works to stop the growth of cancer cells by inhibiting the synthesis of deoxyribonucleic acid (DNA).
- Zusduri 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.
- FDA approval was based on positive results from the Phase 3 ENVISION trial that demonstrated that Zusduri delivered a 78% complete response for patients at 3 months, and of those patients, 79% remained event-free 12 months later.
- Zusduri is administered once a week, every six weeks using a standard urinary catheter in an outpatient setting by a trained healthcare professional.
- Common (≥ 10%) adverse reactions include dysuria, urinary tract infection, and hematuria.
Common laboratory abnormalities include increased creatinine, increased potassium, , decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, and decreased neutrophils.
Development timeline for Zusduri
Further information
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