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

Stem definitionDrug idCAS RN
enzymes 5703 927883-84-9

Description:

MoleculeDescription

Molfile

Synonyms:

  • olipudase alfa
  • olipudase alfa-rpcp
  • xenpozyme
  • GZ402665
Olipudase alfa is a recombinant human acid sphingomyelinase that reduces sphingomyelin (SM) accumulation in organs of patients with Acid Sphingomyelinase Deficiency (ASMD).
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
15 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
June 24, 2022 EMA GENZYME EUROPE BV
Aug. 31, 2022 FDA GENZYME CORP
March 28, 2022 PMDA Sanofi K.K.

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 A16AB25 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Enzymes

Related Drugs by ATC class:

A16AB Enzymes 24 drugs

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

DiseaseRelationSNOMED_IDDOID
Niemann-Pick disease, type B indication 39390005
Niemann-Pick disease, type A indication 52165006




🐶 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:

None

External reference:

IDSource
CHEBI:755825 CHEBI
CHEMBL3707358 ChEMBL_ID
C000608782 MESH_SUPPLEMENTAL_RECORD_UI
DB12835 DRUGBANK_ID
2054161000122108 SNOMEDCT_US
4041694 VANDF
4041695 VANDF
C4278198 UMLSCUI
9966 INN_ID
D10820 KEGG_DRUG
361411 MMSL
40866 MMSL
d09916 MMSL
019170 NDDF
6D5766Q4OP UNII
2610406 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
XENPOZYME HUMAN PRESCRIPTION DRUG LABEL 1 58468-0050 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 20 mg INTRAVENOUS BLA 31 sections
XENPOZYME HUMAN PRESCRIPTION DRUG LABEL 1 58468-0051 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 4 mg INTRAVENOUS BLA 31 sections