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Get patients startedZUSDURI delivered powerful, durable efficacy1
Not an actual patient.
ZUSDURI was studied in the ENVISION phase 3 single-arm, multicenter trial (N=223) as primary tumor ablation in patients with at least 1 prior episode of LG-NMIBC requiring TURBT. Dosing was 75 mg once weekly for 6 weeks as intravesical instillations.1-3*
Complete response (CR)
of patients achieved CR at 3 months with ZUSDURI
n=173/223 (95% CI: 72, 83)1†
Duration of response (DoR)
of patients who achieved CR remained in CR 12 months later (15 months from treatment initiation) n=137/1731‡§
Compelling outcomes, given:
55%
of patients had recurred within 12 months of prior episode1
84%
had multifocal disease3
0%
were treated with TURBT as part of this study treatment1
ZUSDURI demonstrated potent tumor ablation with durable responses1
24-Month Duration of Response
Long-term follow-up in the phase 3 ENVISION trial is ongoing
24-Month follow-up as published in the peer-reviewed Journal of Urology
UGN-102 for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer:
24-Month Duration of Response Results From the Phase 3 ENVISION Trial4
- This updated analysis of the single-arm ENVISION trial reports longer-term data with ZUSDURI in recurrent LG-IR-NMIBC, through at least 24 months after achieving a CR following a course of 6 once-weekly intravesical instillations of ZUSDURI4
- This publication includes information that is not in the FDA-approved Prescribing Information for ZUSDURI and has not been evaluated by FDA1
With longer follow-up, ZUSDURI continues to demonstrate durable CR without TURBT.4
Of the patients who achieved CR at 3 months, a majority remained in CR 24 months later4‖
At 23.7 months median follow-up, the median DoR had not been reached due to the low number of events (95% CI: 29.6, NE)4¶#
LIMITATIONS
Limitations of the current study include its single-arm design, which requires caution when interpreting outcomes without a concurrent control.
CI=confidence interval; ITT=intent-to-treat; LG-IR-NMIBC=low-grade intermediate-risk non-muscle invasive bladder cancer; NE=not estimable; TURBT=transurethral resection of bladder tumor.
*LG-IR-NMIBC was defined as having Ta disease that was histologically confirmed by biopsy and having 1 or 2 of the following: the presence of multiple tumors, a solitary tumor >3 cm, and/or early or frequent recurrence (≥1 occurrence of low-grade NMIBC within 1 year of the current diagnosis). The trial excluded patients with T1 tumors, history of high-grade NMIBC within the previous 2 years, treatment with chemotherapy in the past 2 years except for a single dose of chemotherapy immediately after any previous TURBT, and/or Bacillus Calmette-Guérin treatment within the previous year.1,2
†CR was assessed by cystoscopy, urine cytology, and for-cause biopsy at 3 months.2
‡Based on observed DoR for 173 patients who had a CR.1
§All patients were followed for a minimum of 15 months. Study is ongoing and further results will follow.1
‖Durable CR rate defined as the proportion of patients who maintained CR (ie, no detectable disease) up to that particular follow-up disease assessment, at scheduled disease assessment time points in patients who achieved a CR at 3 months.4
¶As estimated by Kaplan-Meier analysis.4
#In the ENVISION publication, all 240 patients screened and enrolled into the trial were assessed for efficacy and safety. The 240 patients are considered the ITT or safety analysis population. Seventeen patients enrolled in the trial were later found to have protocol deviations that could have interfered with interpretation of efficacy. Per the ZUSDURI PI, those 17 patients were removed from the efficacy evaluation, resulting in an FDA analysis population of 223 patients.1,4
References: 1. ZUSDURI [package insert]. Princeton, NJ: UroGen Pharma, Inc.; 2025. 2. Prasad SM, Shishkov D, Vladimirov Mihaylov N, et al. Primary chemoablation of recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer with UGN-102: a single-arm, open-label, phase 3 trial (ENVISION). J Urol. 2025;213(2):205-216. 3. Data on file. UroGen Pharma, Inc., Princeton, NJ. 4. Prasad SM, Shishkov D, Mihaylov NV, et al. UGN-102 for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer: 24-month duration of response results from the phase 3 ENVISION trial. J Urol. 2026;216(2):194-205.
Indications and Usage
ZUSDURI® is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
IMPORTANT SAFETY INFORMATION
Contraindications
ZUSDURI is contraindicated in patients with perforation of the bladder or in patients with prior hypersensitivity reactions to mitomycin or any component of the product.
Warnings and Precautions
Risks in Patients with Perforated Bladder
ZUSDURI may lead to systemic exposure to mitomycin and severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised. Evaluate the bladder before the intravesical instillation of ZUSDURI and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored.
Embryo-Fetal Toxicity
Based on findings in animals and mechanism of action, ZUSDURI can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of mitomycin resulted in teratogenicity. Advise females of reproductive potential to use effective contraception during treatment with ZUSDURI and for 6 months following the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZUSDURI and for 3 months following the last dose.
Adverse Reactions
Common Adverse Reactions
The most common (≥10%) adverse reactions, including laboratory abnormalities, that occurred in patients treated with ZUSDURI were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria.
Additional Adverse Reactions Information
Clinically relevant adverse reactions occurring in <10% of patients who received ZUSDURI included increased urinary frequency, fatigue, urinary incontinence, urinary retention, urethral stenosis, genital pain, urinary urgency, genital edema, genital pruritus, genital rash, urethritis, acute kidney injury, balanoposthitis, and nocturia.
Use in Specific Populations
Lactation
Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ZUSDURI and for 1 week following the last dose.
Preparation and Administration Information
ZUSDURI is to be administered by intravesical instillation only. Do not administer ZUSDURI by pyelocalyceal instillation or by any other route.
ZUSDURI must be prepared and administered by a healthcare provider. To ensure proper dosing, it is important to follow the preparation instructions found in the ZUSDURI Instructions for Pharmacy and administration instructions found in the ZUSDURI Instructions for Administration.
ZUSDURI may discolor urine to a violet to blue color following the instillation procedure. Advise patients for at least 24 hours post-instillation to avoid urine contact with skin, to void urine sitting on a toilet, and to flush the toilet several times after use. Advise patients to wash hands, perineum or glans with soap and water after each instillation procedure.
ZUSDURI is a hazardous drug. Follow applicable special handling and disposal procedures.
Please click here for Full Prescribing Information, Instructions for Pharmacy, and Instructions for Administration.