BLAINTRAVENOUSINJECTABLEPriority Review
Approved
Mar 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
4/8 — Partial
Priority Review
UNITUXIN (dinutuximab) by United Therapeutics is glycolipid disialoganglioside-directed antibody interactions [moa]. Approved for neuroblastoma. First approved in 2015.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UNITUXIN (dinutuximab) is a chimeric monoclonal antibody that targets GD2, a glycolipid present on neuroblastoma cells, blocking tumor growth and triggering immune-mediated cell death. It is approved for high-risk neuroblastoma in pediatric and young adult patients. The drug works by directing the immune system to recognize and eliminate cancer cells expressing the GD2 antigen.
Peak
Product is at peak revenue stage with established market presence; commercial teams are focused on market maintenance and reimbursement optimization rather than rapid expansion.
Mechanism of Action
Glycolipid Disialoganglioside-directed Antibody Interactions
Pharmacologic Class:
Glycolipid Disialoganglioside-directed Antibody
Indications (1)
Clinical Trials (9)
NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab
Started Jul 2026
118 enrolled
Neuroblastoma
Rapid Administration Pilot for Infusing Dinutuximab
Started Nov 2022
11 enrolled
Neuroblastoma
Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta As Maintenance Therapy in Chinese Participants With High-Risk Neuroblastoma
Started Jun 2022
8 enrolled
High-risk Neuroblastoma
Treatment With Dinutuximab Beta, Zoledronic Acid and Low-dose Interleukin (IL-2) in Patients With Leiomyosarcoma
Started Nov 2021
7 enrolled
Leiomyosarcoma
A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta
Started Sep 2019
125 enrolled
Neuroblastoma
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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.