NDAPYELOCALYCEALPOWDERPriority Review
Approved
Apr 2020
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
16
Data completeness
5/8 — Partial
Priority Review
JELMYTO (mitomycin) by NeuroGenesis Bio is (dna). First approved in 2020.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
JELMYTO (mitomycin) is a small-molecule DNA-alkylating agent approved in 2020 for intracavitary instillation via pyelocalyceal route as a powder formulation. It works by cross-linking DNA at guanine and cytosine-rich sites, suppressing cellular RNA and protein synthesis at high concentrations. The drug treats upper-tract urothelial cancer and represents a novel local delivery approach to a traditionally systemic disease.
Peak4.6 years to LOE
Product is at peak commercial maturity with moderate competitive pressure (8/10); team size and growth trajectory depend on market penetration in niche urothelial cancer indication.
Mechanism of Action
(DNA). The guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking. At high concentrations of the drug, cellular RNA and protein synthesis are also suppressed.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.