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

Stem definitionDrug idCAS RN
small interfering RNA including siRNA, miRNA and piRNA 5415 1834610-13-7

Description:

MoleculeDescription

Molfile

Synonyms:

  • lumasiran
  • oxlumo
  • ALN-G01
  • ALN-65585
  • AD-65585
  • lumasiran sodium
Lumasiran is a hydroxyacid oxidase 1 (HAO1)-directed double-stranded small interfering ribonucleic acid (siRNA), covalently linked to a ligand containing N-acetylgalactosamine (GalNAc). It reduces levels of glycolate oxidase (GO) enzyme by targeting the HAO1 gene messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference. Decreased GO enzyme levels reduce the amount of available glyoxylate, a substrate for oxalate production. As the GO enzyme is upstream of the deficient alanine:glyoxylate aminotransferase (AGT) enzyme that causes PH1, the mechanism of action of lumasiran is independent of the underlying AGXT gene mutation.
  • 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
Nov. 23, 2020 FDA ALNYLAM PHARMS INC
Nov. 19, 2020 EMA Alnylam Netherlands B.V.

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 A16AX18 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Various alimentary tract and metabolism products
MeSH PA D012076 Renal Agents

Related Drugs by ATC class:

A16AX Various alimentary tract and metabolism products 23 drugs
anethole trithionedoxecitinedoxribtimineeliglustatfosdenopteringivosiranglycerol phenylbutyratelonafarnibmigalastatmiglustatnedosirannitisinone show all 23 →

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

DiseaseRelationSNOMED_IDDOID
Primary hyperoxaluria, type I indication 65520001 DOID:0111670




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) OXLUMO ALNYLAM PHARMS INC N214103 Nov. 23, 2020 RX SOLUTION SUBCUTANEOUS 10131907 Aug. 24, 2028 TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) OXLUMO ALNYLAM PHARMS INC N214103 Nov. 23, 2020 RX SOLUTION SUBCUTANEOUS 8828956 Dec. 4, 2028 TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) OXLUMO ALNYLAM PHARMS INC N214103 Nov. 23, 2020 RX SOLUTION SUBCUTANEOUS 8106022 Dec. 12, 2029 TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) OXLUMO ALNYLAM PHARMS INC N214103 Nov. 23, 2020 RX SOLUTION SUBCUTANEOUS 10435692 Dec. 26, 2034 TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) OXLUMO ALNYLAM PHARMS INC N214103 Nov. 23, 2020 RX SOLUTION SUBCUTANEOUS 10465195 Dec. 26, 2034 TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) OXLUMO ALNYLAM PHARMS INC N214103 Nov. 23, 2020 RX SOLUTION SUBCUTANEOUS 10487330 Dec. 26, 2034 TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) OXLUMO ALNYLAM PHARMS INC N214103 Nov. 23, 2020 RX SOLUTION SUBCUTANEOUS 11060093 Dec. 26, 2034 TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) OXLUMO ALNYLAM PHARMS INC N214103 Nov. 23, 2020 RX SOLUTION SUBCUTANEOUS 10612024 Aug. 14, 2035 TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) OXLUMO ALNYLAM PHARMS INC N214103 Nov. 23, 2020 RX SOLUTION SUBCUTANEOUS 10612027 Aug. 14, 2035 TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) OXLUMO ALNYLAM PHARMS INC N214103 Nov. 23, 2020 RX SOLUTION SUBCUTANEOUS 11401517 Aug. 14, 2035 TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) OXLUMO ALNYLAM PHARMS INC N214103 Nov. 23, 2020 RX SOLUTION SUBCUTANEOUS 10478500 Oct. 9, 2035 TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) OXLUMO ALNYLAM PHARMS INC N214103 Nov. 23, 2020 RX SOLUTION SUBCUTANEOUS 11261447 Nov. 20, 2038 TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) OXLUMO ALNYLAM PHARMS INC N214103 Nov. 23, 2020 RX SOLUTION SUBCUTANEOUS Nov. 23, 2027 TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1) TO LOWER URINARY OXALATE LEVELS IN PEDIATRIC AND ADULT PATIENTS
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) OXLUMO ALNYLAM PHARMS INC N214103 Nov. 23, 2020 RX SOLUTION SUBCUTANEOUS Oct. 6, 2029 TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1) TO LOWER PLASMA OXALATE LEVELS IN PEDIATRIC AND ADULT PATIENTS

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Hydroxyacid oxidase 1 (HAO1) mRNA RNA ANTISENSE INHIBITOR DRUG LABEL DRUG LABEL
Asialoglycoprotein receptor 1 Membrane receptor BINDING AGENT DRUG LABEL DRUG LABEL
Asialoglycoprotein receptor 2 Membrane receptor BINDING AGENT DRUG LABEL DRUG LABEL

External reference:

IDSource
D11925 KEGG_DRUG
RZT8C352O1 UNII
1834612-06-4 SECONDARY_CAS_RN
C5418443 UMLSCUI
CHEBI:757227 CHEBI
CHEMBL4297779 ChEMBL_ID
DB15935 DRUGBANK_ID
CHEMBL4650275 ChEMBL_ID
10684 INN_ID
C000716350 MESH_SUPPLEMENTAL_RECORD_UI
13613 IUPHAR_LIGAND_ID
1137368005 SNOMEDCT_US
1137588005 SNOMEDCT_US
1217201009 SNOMEDCT_US
341103 MMSL
39040 MMSL
d09686 MMSL
018570 NDDF
018571 NDDF
2467140 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
OXLUMO HUMAN PRESCRIPTION DRUG LABEL 1 71336-1002 INJECTION, SOLUTION 94.50 mg SUBCUTANEOUS NDA 27 sections