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

Stem definitionDrug idCAS RN
monoclonal antibodies 5776 None

Description:

MoleculeDescription

Molfile

Synonyms:

  • garadacimab
  • garadacimab-gxii
  • andembry
  • CSL312
Garadacimab is a fully human IgG4/lambda recombinant monoclonal antibody which binds to the catalytic domain of activated Factor XII (FXIIa and βFXIIa) and inhibits its catalytic activity. The inhibition of FXIIa, the first factor activated in the contact system, prevents HAE attacks by blocking the activation of prekallikrein to kallikrein and the generation of bradykinin, which is associated with inflammation and swelling in HAE attacks.
  • 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
Feb. 10, 2025 EMA CSL Behring GmbH
June 16, 2025 FDA CSL Behring
Feb. 20, 2025 PMDA CSL Behring K.K.

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
Hereditary angioedema 35.53 25.54 4 4 1477 42619850

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B06AC07 BLOOD AND BLOOD FORMING ORGANS
OTHER HEMATOLOGICAL AGENTS
OTHER HEMATOLOGICAL AGENTS
Drugs used in hereditary angioedema

Related Drugs by ATC class:

B06AC Drugs used in hereditary angioedema 7 drugs
berotralstatconestat alfadonidalorsenecallantideicatibantlanadelumabsebetralstat

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

DiseaseRelationSNOMED_IDDOID
Hereditary angioneurotic edema indication 82966003 DOID:14735




🐶 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
Coagulation factor XII Enzyme INHIBITOR Kd 7.26 DRUG LABEL DRUG LABEL

External reference:

IDSource
2162134-62-3 SECONDARY_CAS_RN
C000731822 MESH_SUPPLEMENTAL_RECORD_UI
13402 IUPHAR_LIGAND_ID
DB15629 DRUGBANK_ID
4044062 VANDF
4044063 VANDF
C5238067 UMLSCUI
10996 INN_ID
D12613 KEGG_DRUG
44182 MMSL
d10289 MMSL
020146 NDDF
32W6AJL0DY UNII
2717168 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ANDEMBRY HUMAN PRESCRIPTION DRUG LABEL 1 63833-925 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 28 sections