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

Stem definitionDrug idCAS RN
humanized origin 5279 680188-33-4

Description:

MoleculeDescription

Molfile

Synonyms:

  • ibalizumab
  • TNX-355
  • TMB-355
  • trogarzo
  • ibalizumab-uiyk
Ibalizumab-uiyk, a recombinant humanized monoclonal antibody, blocks HIV-1 from infecting CD4+ T cells by binding to domain 2 of CD4 and interfering with post-attachment steps required for the entry of HIV-1 virus particles into host cells and preventing the viral transmission that occurs via cell-cell fusion
  • 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
March 6, 2018 FDA TAIMED BIOLOGICS USA
Sept. 26, 2019 EMA Theratechnologies International Limited

FDA Adverse Event Reporting System (Female)

None

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
Viral load increased 83.60 48.10 14 180 2983 42618158

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
Viral load increased 59.01 40.59 9 149 3381 110585760
Product use in unapproved therapeutic environment 50.93 40.59 6 152 318 110588823
Blood HIV RNA increased 47.16 40.59 7 151 2181 110586960

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J05AX23 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Other antivirals
FDA CS M0556300 Antibodies, Monoclonal, Humanized
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D019380 Anti-HIV Agents
MeSH PA D044966 Anti-Retroviral Agents
FDA MoA N0000193805 CD4-directed Antibody Interactions
FDA EPC N0000193806 CD4-directed Blocking Antibody
FDA MoA N0000193807 HIV 1 Post-attachment Fusion Inhibitors
FDA EPC N0000193808 Human Immunodeficiency Virus 1 Post-attachment Fusion Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:64946 anti-HIV agent

Related Drugs by ATC class:

J05AX Other antivirals 15 drugs
amenamevirbaloxavir marboxilbulevirtideenfuvirtidefavipiravirfostemsavirinosine pranobexlenacapavirletermovirmaravirocmaribavirmoroxydine show all 15 →

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

DiseaseRelationSNOMED_IDDOID
Human immunodeficiency virus infection indication 86406008 DOID:526




🐶 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
T-cell surface glycoprotein CD4 Membrane receptor ANTIBODY BINDING UNKNOWN DRUG LABEL

External reference:

IDSource
LT369U66CE UNII
4037413 VANDF
C1434792 UMLSCUI
CHEBI:750107 CHEBI
CHEMBL1743029 ChEMBL_ID
DB12698 DRUGBANK_ID
D09575 KEGG_DRUG
8818 INN_ID
C481504 MESH_SUPPLEMENTAL_RECORD_UI
10208 IUPHAR_LIGAND_ID
770963001 SNOMEDCT_US
771575008 SNOMEDCT_US
271552 MMSL
33850 MMSL
33959 MMSL
d08751 MMSL
017473 NDDF
2043283 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TROGARZO HUMAN PRESCRIPTION DRUG LABEL 1 62064-122 INJECTION, SOLUTION 150 mg INTRAVENOUS BLA 27 sections