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

Stem definitionDrug idCAS RN
monoclonal antibodies (chimeric origin); tumor 5837 None

Description:

MoleculeDescription

Molfile

Synonyms:

  • zolbetuximab
  • zolbetuximab-clzb
  • vyloy
  • IMAB362
  • claudiximab
Zolbetuximab-clzb is a monoclonal antibody directed against Claudin 18.2 (CLDN18.2). Zolbetuximab-clzb binds to CLDN18.2-expressing tumor cells and induces antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
  • 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
Oct. 18, 2024 FDA Astellas Pharma
Sept. 19, 2024 EMA Astellas Pharma Europe B.V.
March 26, 2024 PMDA Astellas Pharma Inc.

FDA Adverse Event Reporting System (Female)

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
Nausea 235.32 54.60 141 785 1110175 89517346
Vomiting 107.55 54.60 77 849 788216 89839305
Hypoalbuminaemia 96.37 54.60 24 902 15873 90611648
Decreased appetite 91.20 54.60 53 873 376487 90251034
Protein-losing gastroenteropathy 85.92 54.60 12 914 326 90627195
Malignant neoplasm progression 77.70 54.60 32 894 106838 90520683
Blood albumin decreased 75.54 54.60 20 906 16783 90610738
Myelosuppression 67.58 54.60 24 902 53567 90573954
Ascites 62.54 54.60 22 904 47718 90579803

FDA Adverse Event Reporting System (Male)

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
Nausea 475.17 45.23 260 1623 396539 42222913
Hypoalbuminaemia 214.10 45.23 61 1822 15549 42603903
Vomiting 144.20 45.23 111 1772 289612 42329840
Ascites 140.43 45.23 62 1821 56616 42562836
Decreased appetite 132.36 45.23 90 1793 193047 42426405
Blood albumin decreased 119.97 45.23 39 1844 15363 42604089
Malignant neoplasm progression 52.18 45.23 41 1842 108359 42511093
Gastritis 49.01 45.23 23 1860 23924 42595528
Neutrophil count decreased 46.53 45.23 31 1852 63384 42556068

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
Nausea 527.38 45.33 342 2441 1235348 109351168
Hypoalbuminaemia 321.50 45.33 85 2698 28889 110557627
Ascites 242.37 45.33 90 2693 92718 110493798
Decreased appetite 226.77 45.33 143 2640 475703 110110813
Blood albumin decreased 204.28 45.33 59 2724 27593 110558923
Vomiting 165.46 45.33 154 2629 910521 109675995
Malignant neoplasm progression 115.19 45.33 65 2718 174502 110412014
Protein-losing gastroenteropathy 88.93 45.33 16 2767 890 110585626
Neutrophil count decreased 85.04 45.33 47 2736 120894 110465622
Myelosuppression 81.33 45.33 42 2741 94298 110492218
Gastritis 77.20 45.33 34 2749 53665 110532851

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FX31 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Other monoclonal antibodies and antibody drug conjugates
FDA MoA N0000194106 Claudin 18.2-directed Antibody Interactions
FDA EPC N0000194107 Claudin 18.2-directed Cytolytic Antibody
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

L01FX Other monoclonal antibodies and antibody drug conjugates 29 drugs
amivantamabbelantamab mafodotinblinatumomabbrentuximab vedotincatumaxomabdatopotamab deruxtecanelotuzumabelranatamabenfortumab vedotinepcoritamabgemtuzumab ozogamicinglofitamab show all 29 →

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

DiseaseRelationSNOMED_IDDOID
Locally advanced or metastatic HER2-negative gastroesophageal junction adenocarcinoma indication 187734007
Locally advanced or metastatic HER2-negative gastric adenocarcinoma indication 408647009 DOID:3717




🐶 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Claudin-18 Membrane other ANTIBODY BINDING Kd 8.54 DRUG LABEL DRUG LABEL

External reference:

IDSource
CHEMBL2109427 ChEMBL_ID
DB15118 DRUGBANK_ID
4043498 VANDF
4043499 VANDF
C5964728 UMLSCUI
CHEBI:754224 CHEBI
1496553-00-4 SECONDARY_CAS_RN
390115 MMSL
43363 MMSL
d10229 MMSL
9209 IUPHAR_LIGAND_ID
10473 INN_ID
2695869 RXNORM
43534311000001109 SNOMEDCT_US
C585662 MESH_SUPPLEMENTAL_RECORD_UI
D11527 KEGG_DRUG
TF5MPQ8WGY UNII
019900 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
VYLOY HUMAN PRESCRIPTION DRUG LABEL 1 0469-3425 INJECTION, POWDER, FOR SUSPENSION 20 mg INTRAVENOUS BLA 24 sections
VYLOY HUMAN PRESCRIPTION DRUG LABEL 1 0469-4425 INJECTION, POWDER, FOR SUSPENSION 20 mg INTRAVENOUS BLA 24 sections