inebilizumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
humanized origin	5397	1299440-37-1

Description:

Molecule	Description
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

Molecule

Description

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

Approvals:

Date	Agency	Company
April 25, 2022	EMA	Horizon Therapeutics Ireland DAC
June 11, 2020	FDA	VIELA BIO
March 23, 2021	PMDA	Mitsubishi Tanabe Pharma Corporation

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L04AA47	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
FDA MoA	N0000191422	CD19-directed Antibody Interactions
FDA EPC	N0000194013	CD19-directed Cytolytic Antibody

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

Disease	Relation	SNOMED_ID	DOID
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
B-lymphocyte antigen CD19	Surface antigen	P15391	CD19_HUMAN	ANTIBODY BINDING	Kd	9.80		IUPHAR	DRUG LABEL
Low affinity immunoglobulin gamma Fc region receptor III-A	Membrane receptor	P08637	FCG3A_HUMAN	ANTIBODY BINDING	Kd	7.11		SCIENTIFIC LITERATURE

External reference:

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

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
UPLIZNA	HUMAN PRESCRIPTION DRUG LABEL	1	72677-551	INJECTION	10 mg	INTRAVENOUS	BLA	28 sections
UPLIZNA	HUMAN PRESCRIPTION DRUG LABEL	1	72677-551	INJECTION	10 mg	INTRAVENOUS	BLA	28 sections
UPLIZNA	HUMAN PRESCRIPTION DRUG LABEL	1	75987-150	INJECTION	10 mg	INTRAVENOUS	BLA	28 sections
UPLIZNA	HUMAN PRESCRIPTION DRUG LABEL	1	75987-150	INJECTION	10 mg	INTRAVENOUS	BLA	28 sections