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

Stem definitionDrug idCAS RN
primate origin 5676 2097104-58-8

Description:

MoleculeDescription

Molfile

Synonyms:

  • spesolimab
  • spesolimab-sbzo
  • BI 655130
  • spevigo
Spesolimab-sbzo is a humanized monoclonal immunoglobulin G1 antibody that inhibits interleukin-36 (IL-36) signaling by specifically binding to the IL36R. Binding of spesolimab-sbzo to IL36R prevents the subsequent activation of IL36R by cognate ligands (IL-36 alpha, beta and gamma) and downstream activation of pro inflammatory and pro-fibrotic pathways. The precise mechanism linking reduced IL36R activity and the treatment of flares of GPP is unclear.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
0.90 g P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Sept. 1, 2022 FDA BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Dec. 9, 2022 EMA BOEHRINGER INGELHEIM INTERNATIONAL GMBH
Sept. 26, 2022 PMDA NIPPON BOEHRINGER INGELHEIM CO., LTD.

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:

SourceCodeDescription
ATC L04AC22 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Interleukin inhibitors
MeSH PA D003879 Dermatologic Agents
FDA EPC N0000194039 Interleukin-36 Receptor Antagonist
FDA MoA N0000194040 Interleukin-36 Receptor Antagonists
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:67079 anti-inflammatory agent

Related Drugs by ATC class:

L04AC Interleukin inhibitors 18 drugs

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

DiseaseRelationSNOMED_IDDOID
Pustular psoriasis indication 200973000
Erythrodermic psoriasis indication 200977004
Generalized pustular psoriasis indication 238612002




🐶 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
Interleukin-1 receptor-like 2 Membrane receptor ANTAGONIST Kd 9.65 DRUG LABEL DRUG LABEL

External reference:

IDSource
CHEBI:757347 CHEBI
CHEMBL4297911 ChEMBL_ID
C000712973 MESH_SUPPLEMENTAL_RECORD_UI
12169 IUPHAR_LIGAND_ID
DB15626 DRUGBANK_ID
1025551000122104 SNOMEDCT_US
4041692 VANDF
4041693 VANDF
C5238146 UMLSCUI
10845 INN_ID
D12066 KEGG_DRUG
361370 MMSL
40858 MMSL
d09913 MMSL
019169 NDDF
5IB2J79MCX UNII
2610417 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
SPEVIGO HUMAN PRESCRIPTION DRUG LABEL 1 0597-0035 INJECTION 60 mg INTRAVENOUS BLA 30 sections
SPEVIGO HUMAN PRESCRIPTION DRUG LABEL 1 0597-0035 INJECTION 60 mg INTRAVENOUS BLA 30 sections
SPEVIGO HUMAN PRESCRIPTION DRUG LABEL 1 0597-0620 INJECTION 150 mg INTRAVENOUS BLA 30 sections
SPEVIGO HUMAN PRESCRIPTION DRUG LABEL 1 0597-0620 INJECTION 150 mg INTRAVENOUS BLA 30 sections
SPEVIGO HUMAN PRESCRIPTION DRUG LABEL 1 0597-7705 INJECTION 300 mg INTRAVENOUS BLA 30 sections
SPEVIGO HUMAN PRESCRIPTION DRUG LABEL 1 0597-7705 INJECTION 300 mg INTRAVENOUS BLA 30 sections
SPEVIGO HUMAN PRESCRIPTION DRUG LABEL 1 50222-360 INJECTION 60 mg SUBCUTANEOUS BLA 30 sections
SPEVIGO HUMAN PRESCRIPTION DRUG LABEL 1 50222-361 INJECTION 150 mg SUBCUTANEOUS BLA 30 sections
SPEVIGO HUMAN PRESCRIPTION DRUG LABEL 1 50222-362 INJECTION 300 mg SUBCUTANEOUS BLA 30 sections