NDAINTRAVESICALPOWDER
Approved
Jun 2025
Lifecycle
Launch
Competitive Pressure
8/100
Clinical Trials
16
Data completeness
5/8 — Partial
ZUSDURI (mitomycin) by NeuroGenesis Bio is alkylating activity [moa]. Approved for glaucoma, non-muscle invasive bladder cancer. First approved in 2025.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZUSDURI (mitomycin) is an alkylating agent administered intravesically as a powder formulation for treating non-muscle invasive bladder cancer and glaucoma. It works by directly alkylating DNA to inhibit tumor cell proliferation and reduce intraocular pressure. The product launched in June 2025 under NDA approval from NeuroGenesis Bio.
Launch4.7 years to LOE
Early-stage launch product with significant competitive pressure (8/10) in glaucoma market; expect investment in field and marketing infrastructure build-out.
Mechanism of Action
Alkylating Activity
Indications (2)
Clinical Trials (16)
Comparative Study of Mitomycin and Lobaplatin in Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy
Started Sep 2022
201 enrolled
Colorectal CancerChemotherapy EffectSurgery+2 more
Safety and Efficacy of an Ab Interno Gelatin Stent (XEN63) With or Without Mitomycin C
Started Nov 2020
30 enrolled
Glaucoma, Open-Angle
Ab Interno Gelatin Stent With Mitomycin C Using Targeted Supra-tenon's Placement
Started Jun 2019
142 enrolled
Glaucoma
Comparing Preoperative Injection of Mitomycin-C vs. Intraoperative Injection of Mitomycin-C vs. Topical Application of Mitomycin-C (Conventional Use) in Trabeculectomy
Started Mar 2019
19 enrolled
Glaucoma Open-Angle PrimaryGlaucomaOpen Angle Glaucoma+1 more
A Study of Mitomycin-c/ Capecitabine ChemoRadiotherapy Combined With Nivolumab Monotherapy or Ipilumimab and Nivolumab, as Bladder Sparing Curative Treatment for Muscle Invasive Bladder Cancer: the CRIMI Study
Started Jan 2019
50 enrolled
Urinary Bladder CancerInvasive Bladder Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.