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

Stem definitionDrug idCAS RN
humanized origin 5397 1299440-37-1

Description:

MoleculeDescription

Molfile

Synonyms:

  • inebilizumab
  • inebilizumab-cdon
  • uplizna
  • 16C4-aFuc
  • A-fucosylated anti-CD19 antibody
  • anti-CD19 MAb-Viela-Bio
  • MEDI-551
  • MT-0551
Inebilizumab-cdon is a CD19-directed humanized afucosylated IgG1 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The precise mechanism by which inebilizumab-cdon exerts its therapeutic effects in NMOSD is unknown but is presumed to involve binding to CD19, a cell surface antigen presents on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, inebilizumab-cdon results in antibody-dependent cellular cytolysis (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
June 11, 2020 FDA VIELA BIO
March 23, 2021 PMDA Mitsubishi Tanabe Pharma Corporation
April 25, 2022 EMA Horizon Therapeutics Ireland DAC

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
Neuromyelitis optica spectrum disorder 50.28 44.12 8 330 1482 90626627

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AG10 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Monoclonal antibodies
FDA MoA N0000191422 CD19-directed Antibody Interactions
FDA EPC N0000194013 CD19-directed Cytolytic Antibody
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent

Related Drugs by ATC class:

L04AG Monoclonal antibodies 14 drugs

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

DiseaseRelationSNOMED_IDDOID
Neuromyelitis optica indication 25044007 DOID:8869
Tuberculosis contraindication 56717001
Viral hepatitis type B contraindication 66071002 DOID:2043




🐶 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
B-lymphocyte antigen CD19 Surface antigen ANTIBODY BINDING Kd 9.80 IUPHAR DRUG LABEL
Low affinity immunoglobulin gamma Fc region receptor III-A Membrane receptor ANTIBODY BINDING Kd 7.11 SCIENTIFIC LITERATURE

External reference:

IDSource
D11757 KEGG_DRUG
74T7185BMM UNII
4039495 VANDF
4039496 VANDF
C4519594 UMLSCUI
CHEBI:754166 CHEBI
CHEMBL2109334 ChEMBL_ID
DB12530 DRUGBANK_ID
9985 INN_ID
C000609745 MESH_SUPPLEMENTAL_RECORD_UI
7992 IUPHAR_LIGAND_ID
879883007 SNOMEDCT_US
879892005 SNOMEDCT_US
335069 MMSL
38531 MMSL
d09575 MMSL
018404 NDDF
2373950 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
UPLIZNA HUMAN PRESCRIPTION DRUG LABEL 1 75987-150 INJECTION 10 mg INTRAVENOUS BLA 30 sections