Unituxin(dinutuximab)
Unituxin (dinutuximab) is an antibody pharmaceutical. Dinutuximab was first approved as Unituxin on 2015-03-10. It is used to treat neuroblastoma in the USA. It has been approved in Europe to treat neuroblastoma.
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Commercial
Trade Name
FDA
EMA
Unituxin
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Dinutuximab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Unituxin | dinutuximab | United Therapeutics | N-125516 RX | 2015-03-10 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| unituxin | Biologic Licensing Application | 2024-04-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| neuroblastoma | EFO_0000621 | D009447 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
dinutuximab, Unituxin, United Therapeutics Corporation | |||
| 2122-03-10 | Orphan excl. | ||
Patent Expiration
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HCPCS
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Clinical
Clinical Trials
48 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroblastoma | D009447 | EFO_0000621 | — | 16 | 17 | 8 | 1 | 5 | 43 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ganglioneuroblastoma | D018305 | — | — | — | 3 | 3 | — | — | 6 |
| Osteosarcoma | D012516 | — | — | 2 | 2 | 1 | — | — | 5 |
| Retinoblastoma | D012175 | — | — | 1 | — | 1 | — | 1 | 3 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 1 | 1 | — | — | 1 |
| Small cell lung carcinoma | D055752 | — | — | — | 1 | 1 | — | — | 1 |
| Sarcoma | D012509 | — | — | — | — | 1 | — | — | 1 |
| Rhabdomyosarcoma | D012208 | — | — | — | — | 1 | — | — | 1 |
| Alveolar rhabdomyosarcoma | D018232 | — | — | — | — | 1 | — | — | 1 |
| Embryonal rhabdomyosarcoma | D018233 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | 3 | 1 | — | — | — | 4 |
| Neoplasms | D009369 | — | C80 | 2 | 2 | — | — | — | 3 |
| Residual neoplasm | D018365 | — | — | — | 1 | — | — | — | 1 |
| Leiomyosarcoma | D007890 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease progression | D018450 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Neurotoxicity syndromes | D020258 | — | G92 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dinutuximab |
| INN | dinutuximab |
| Description | Dinutuximab (Ch14.18, tradename Unituxin) and Dinutuximab beta (tradename Qarziba) are monoclonal antibodies used as a second-line treatment for children with high-risk neuroblastoma. Each antibody is made of both mouse and human components and targets glycolipid GD2, expressed on neuroblastoma cells and on normal cells of neuroectodermal origin, including the central nervous system and peripheral nerves. They differ in that dinutuximab is manufactured using mouse cells, and dinutuximab beta is manufactured using hamster cells. The dosing regime differs, and dinutuximab is given in combination with granulocyte-macrophage colony stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), while dinutuximab beta can be given alone.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3137342 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09077 |
| UNII ID | 7SQY4ZUD30 (ChemIDplus, GSRS) |
Target
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Unituxin – United Therapeutics
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Trends
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Additional graphs summarizing 1,590 documents
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Safety
Black-box Warning
Black-box warning for: Unituxin
Adverse Events
Top Adverse Reactions
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705 adverse events reported
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