BLAINTRAVENOUSINJECTABLEPriority Review
Approved
Mar 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
10
Data completeness
3/8 — Basic
Priority Review
UNITUXIN (dinutuximab) by United Therapeutics is glycolipid disialoganglioside-directed antibody interactions [moa]. First approved in 2015.
Drug data last refreshed 31m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UNITUXIN (dinutuximab) is a monoclonal antibody that targets GD2, a glycolipid expressed on neuroblastoma cells, enabling immune-mediated tumor cell destruction. It is used in combination with GM-CSF, IL-2, and isotretinoin for high-risk neuroblastoma patients. The drug works by binding to GD2 on the cell surface and facilitating antibody-dependent cellular cytotoxicity.
Peak
Established rare pediatric oncology asset with stable market position; commercial team likely lean but specialized in pediatric/rare disease infrastructure.
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 (10)
NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab
Started Dec 2026
118 enrolled
Neuroblastoma
Phase I/II Trial of Dinutuximab Beta in Combination With Irinotecan and Rapamycin in Pediatric, Adolescents and Adult Patients With Relapsed/Refractory Bone Tumors.
Started Oct 2026
89 enrolled
OsteosarcomasBone CancerEwing Sarcomas
Rapid Administration Pilot for Infusing Dinutuximab
Started Nov 2022
30 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
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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.