Naxitamab
Danyelza (naxitamab) is an antibody pharmaceutical. Naxitamab was first approved as Danyelza on 2020-11-25. It is used to treat neuroblastoma in the USA.
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FDA Novel Drug Approvals 2020
Drugs Approved for Childhood Cancers
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
Trade Name
FDA
EMA
Danyelza
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)
Naxitamab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Danyelza | naxitamab-gqgk | Y-mAbs Therapeutics | N-761171 RX | 2020-11-25 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| danyelza | Biologic Licensing Application | 2021-01-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| neuroblastoma | EFO_0000621 | D009447 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
naxitamab, Danyelza, Y-mABs Therapeutics, Inc | |||
| 2027-11-25 | Orphan excl. | ||
Patent Expiration
No data
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| J9348 | Injection, naxitamab-gqgk, 1 mg |
Clinical
Clinical Trials
12 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroblastoma | D009447 | EFO_0000621 | 5 | 7 | — | — | 2 | 12 | |
| Neoplasms | D009369 | C80 | 1 | 1 | — | — | — | 1 | |
| Osteosarcoma | D012516 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | NAXITAMAB |
| INN | naxitamab |
| Description | Naxitamab, sold under the brand name Danyelza, is an anti-cancer medication. It is a monoclonal antibody used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for people one year of age and older with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1879925-92-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297984 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15965 |
| UNII ID | 9K8GNJ2874 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Danyelza - Y-mAbs Therapeutics
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€
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 106 documents
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Safety
Black-box Warning
Black-box warning for: Danyelza
Adverse Events
Top Adverse Reactions
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831 adverse events reported
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