BLAINTRAVENOUSSOLUTIONPriority Review
Approved
Nov 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
4/8 — Partial
Priority Review
DANYELZA (naxitamab) by Y-mAbs Therapeutics is glycolipid disialoganglioside-directed antibody interactions [moa]. First approved in 2020.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DANYELZA (naxitamab) is a monoclonal antibody targeting glycolipid disialoganglioside (GD2), a tumor-associated antigen expressed on neuroblastoma and other cancers. It works by directing immune interactions against GD2-positive cells. The drug is administered intravenously as a solution.
Peak
Product is in peak commercial phase with moderate competitive pressure (30%), indicating stable team structures and established go-to-market operations.
Mechanism of Action
Glycolipid Disialoganglioside-directed Antibody Interactions
Pharmacologic Class:
Glycolipid Disialoganglioside-directed Antibody
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5
Started May 2026
10 enrolled
High-Risk Neuroblastoma
Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
Started Sep 2025
31 enrolled
Metastatic Triple-Negative Breast Cancer
Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
Started Jun 2025
18 enrolled
NeuroblastomaNeuroblastoma RecurrentRelapsed Neuroblastoma+1 more
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.
Started Oct 2023
62 enrolled
Neuroblastoma
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
Started Sep 2022
93 enrolled
Neuroblastoma
Worked on DANYELZA at Y-mAbs Therapeutics? Share your interview experience or compensation data (+7 days Pro)
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.