BLAINTRAVENOUSINJECTABLEPriority Review
Approved
Mar 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
9
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 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UNITUXIN (dinutuximab) is a chimeric monoclonal antibody targeting GD2 (glycolipid disialoganglioside), a tumor-associated antigen expressed on neuroblastoma cells. It is indicated for high-risk neuroblastoma in pediatric patients as part of multimodal therapy. The drug works by binding to GD2 on tumor cells, triggering antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity to eliminate cancer cells.
Peak
Product is at peak commercial maturity in a niche, rare disease oncology segment with sustained but limited team scale opportunities.
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 (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.