Dinutuximab is a Monoclonal Antibody owned by United Therapeutics, and is involved in 23 clinical trials, of which 12 were completed, 9 are ongoing, and 2 are planned.

Dinutuximab binds to the glycolipid GD2 expressed on cancer cells. This glycolipid is expressed on neuroblastoma cells and on normal cells of neuroectodermal origin, including the central nervous system and peripheral nerves. Dinutuximab binds to cell surface GD2 and induces cell lysis of GD2­ expressing cells through antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).

The revenue for Dinutuximab is expected to reach a total of $2.4bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Dinutuximab NPV Report.

Dinutuximab was originated by University of California San Diego and is currently owned by United Therapeutics.

Dinutuximab Overview

Dinutuximab (Unituxin) is a chimeric monoclonal antibody, composed of a combination of mouse and human DNA acts as an anti-neoplastic agent. It is formulated as solution, concentrate solution for intravenous or Intravenous drip route of administration. Unituxin is indicated in combination with granulocyte-macrophage colonystimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

Dinutuximab is under development for the treatment of osteosarcoma. It was also under development for relapsed and refractory small-cell lung cancer.

United Therapeutics Overview

United Therapeutics develops and commercializes innovative pharmaceutical products for the treatment of cardiovascular disorders, particularly pulmonary arterial hypertension, and infectious diseases. The company’s products consist of prostacyclin analogues including Remodulin (treprostinil) injection; Tyvaso (treprostinil) inhalation solution; and Orenitram (treprostinil). Adcirca (tadalafil) is a phosphodiesterase type 5 (PDE-5) inhibitor and Unituxin (dinutuximab), a monoclonal antibody for oncologic applications, are the other products. Its product candidates include monoclonal antibodies (mAbs), glycobiology antiviral agents and cell-based therapies. The company also develops engineered lungs for transplantation in pre-clinical stage. It manufactures products in its facility in Silver Spring, Maryland. It markets its products in the US, Europe, South America and Israel. United Therapeutics is headquartered in Silver Spring, Maryland, the US.

The company reported revenues of (US Dollars) US$1,685.5 million for the fiscal year ended December 2021 (FY2021), an increase of 13.6% over FY2020. In FY2021, the company’s operating margin was 32.8%, compared to an operating margin of 39.3% in FY2020. In FY2021, the company recorded a net margin of 28.2%, compared to a net margin of 34.7% in FY2020. The company reported revenues of US$516 million for the third quarter ended September 2022, an increase of 10.5% over the previous quarter.

Quick View – Dinutuximab

Report Segments
  • Innovator (NME)
Drug Name
  • Dinutuximab
Administration Pathway
  • Intravenous
  • Intravenous Drip
Therapeutic Areas
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.