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

Stem definitionDrug idCAS RN
primate origin 5512 2049079-64-1

Description:

MoleculeDescription

Molfile

Synonyms:

  • sutimlimab
  • sutimlimab-jome
  • enjaymo
  • TNT009
  • BIVV009
  • sutimlimab (genetical recombination)
Sutimlimab-jome is an immunoglobulin G (IgG), subclass 4 (IgG4) monoclonal antibody (mAb) that inhibits the classical complement pathway (CP) and specifically binds to complement protein component 1, s subcomponent (C1s), a serine protease which cleaves C4. Sutimlimab­-jome does not inhibit the lectin and alternative pathways. Inhibition of the classical complement pathway at the level of C1s prevents deposition of complement opsonins on the surface of RBCs, resulting in inhibition of hemolysis in patients with CAD.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
0.46 g P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Feb. 4, 2022 FDA BIOVERATIV THERAPEUTICS INC
June 20, 2022 PMDA SANOFI K.K
Nov. 15, 2022 EMA GENZYME EUROPE BV

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

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
Haemolysis 56.06 43.62 11 170 15628 110573490
Disseminated varicella zoster virus infection 49.93 43.62 7 174 1274 110587844
Hepatitis viral 48.95 43.62 7 174 1468 110587650

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AJ04 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Complement inhibitors
FDA MoA N0000193990 Classical Complement Pathway Inhibitors
FDA EPC N0000193991 Classical Complement Pathway Inhibitor
CHEBI has role CHEBI:75835 anti-anaemic agent

Related Drugs by ATC class:

L04AJ Complement inhibitors 10 drugs
avacopancrovalimab-akkzdanicopaneculizumabiptacopanpegcetacoplanpozelimabravulizumabvilobelimabzilucoplan

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

DiseaseRelationSNOMED_IDDOID
Cold autoimmune hemolytic anemia indication 398937006




🐶 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
Complement C1s subcomponent Enzyme INHIBITOR Kd 9.59 DRUG LABEL DRUG LABEL

External reference:

IDSource
CHEBI:757276 CHEBI
CHEMBL4297832 ChEMBL_ID
C000634098 MESH_SUPPLEMENTAL_RECORD_UI
9807 IUPHAR_LIGAND_ID
DB14996 DRUGBANK_ID
548401000202100 SNOMEDCT_US
4041155 VANDF
4041156 VANDF
C4727016 UMLSCUI
D11530 KEGG_DRUG
10737 INN_ID
356904 MMSL
40469 MMSL
d09855 MMSL
018948 NDDF
GNWE7KJ995 UNII
2591404 RXNORM
C000623343 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Enjaymo HUMAN PRESCRIPTION DRUG LABEL 1 55292-820 INJECTION, SOLUTION, CONCENTRATE 50 mg INTRAVENOUS BLA 28 sections
Enjaymo HUMAN PRESCRIPTION DRUG LABEL 1 80203-347 INJECTION, SOLUTION, CONCENTRATE 50 mg INTRAVENOUS BLA 28 sections