naxitamab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antitumor, monoclonal antibodies 5435 1879925-92-4

Description:

MoleculeDescription

Molfile

Synonyms:

  • naxitamab
  • naxitamab-gqgk
  • danyelza
  • hu3F8
  • hu3F8-IgG1
Naxitamab-gqgk is a glycolipid disialoganglioside (GD2)-binding recombinant humanized monoclonal IgG1 antibody, that contains human framework regions and murine complementarity-determining regions. Naxitamab-gqgk binds to the glycolipid GD2. GD2 is a disialoganglioside that is overexpressed on neuroblastoma cells and other cells of neuroectodermal origin, including the central nervous system and peripheral nerves. In vitro, naxitamab-gqgk was able to bind to cell surface GD2 and induce complement dependent cytotoxicity (CDC) and antibody dependent cell-mediated cytotoxicity (ADCC).
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Nov. 25, 2020 FDA Y-MABS THERAPEUTICS INC

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hypotension 72.63 59.11 31 224 523818 110065226

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FX21 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Other monoclonal antibodies and antibody drug conjugates
FDA MoA N0000191499 Glycolipid Disialoganglioside-directed Antibody Interactions
FDA EPC N0000191500 Glycolipid Disialoganglioside-directed Antibody
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

L01FX Other monoclonal antibodies and antibody drug conjugates 29 drugs

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Neuroblastoma indication 432328008 DOID:769




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
D11416 KEGG_DRUG
9K8GNJ2874 UNII
C4733494 UMLSCUI
CHEBI:757411 CHEBI
CHEMBL4297984 ChEMBL_ID
DB15965 DRUGBANK_ID
10918 INN_ID
C000718263 MESH_SUPPLEMENTAL_RECORD_UI
11341 IUPHAR_LIGAND_ID
1137637004 SNOMEDCT_US
1137667005 SNOMEDCT_US
4039899 VANDF
4039900 VANDF
341259 MMSL
39053 MMSL
d09688 MMSL
018572 NDDF
2474039 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DANYELZA HUMAN PRESCRIPTION DRUG LABEL 1 50633-230 INJECTION 40 mg INTRAVENOUS BLA 31 sections
DANYELZA HUMAN PRESCRIPTION DRUG LABEL 1 73042-201 INJECTION 40 mg INTRAVENOUS BLA 31 sections