nedosiran 🐶 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 5746 2247026-22-6

Description:

MoleculeDescription

Molfile

Synonyms:

  • nedosiran
  • nedosiran sodium
  • rivfloza
Nedosiran is a double-stranded siRNA, conjugated to GalNAc aminosugar residues. After subcutaneous administration, the GalNAc-conjugated sugars bind to asialoglycoprotein receptors (ASGPR) to deliver nedosiran to hepatocytes. Nedosiran reduces levels of hepatic lactate dehydrogenase (LDH) via the degradation of LDHA messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference. The reduction of hepatic LDH by nedosiran reduces the production of oxalate by the liver, thereby reducing subsequent oxalate burden.
  • 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
Sept. 29, 2023 FDA NOVO NORDISK INC

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 A16AX25 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Various alimentary tract and metabolism products

Related Drugs by ATC class:

A16AX Various alimentary tract and metabolism products 23 drugs
anethole trithionedoxecitinedoxribtimineeliglustatfosdenopteringivosiranglycerol phenylbutyratelonafarniblumasiranmigalastatmiglustatnitisinone 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 128MG BASE/0.8ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION 10738311 Oct. 9, 2035 METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION 11359203 Oct. 9, 2035 METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 160MG BASE/ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION 10738311 Oct. 9, 2035 METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 160MG BASE/ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION 11359203 Oct. 9, 2035 METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION 10738311 Oct. 9, 2035 METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION 11359203 Oct. 9, 2035 METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION 11286488 Oct. 12, 2038 METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION 11661604 Oct. 12, 2038 METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 160MG BASE/ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION 11286488 Oct. 12, 2038 METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 160MG BASE/ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION 11661604 Oct. 12, 2038 METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION 11286488 Oct. 12, 2038 METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)
EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION 11661604 Oct. 12, 2038 METHOD OF TREATING PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION March 27, 2028 NEW PATIENT POPULATION
EQ 160MG BASE/ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION March 27, 2028 NEW PATIENT POPULATION
EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION March 27, 2028 NEW PATIENT POPULATION
EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION Sept. 29, 2028 NEW CHEMICAL ENTITY
EQ 160MG BASE/ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION Sept. 29, 2028 NEW CHEMICAL ENTITY
EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION Sept. 29, 2028 NEW CHEMICAL ENTITY
EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION Sept. 29, 2030 TO LOWER URINARY OXALATE LEVELS IN CHILDREN 9 YEARS OF AGE AND OLDER AND ADULTS WITH PRIMARY HYPEROXALURIA TYPE 1 (PH1) AND RELATIVELY PRESERVED KIDNEY FUNCTION, E.G., EGFR GREATER THAN OR EQUAL TO 30 ML/MIN/1.73 M^2
EQ 160MG BASE/ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION Sept. 29, 2030 TO LOWER URINARY OXALATE LEVELS IN CHILDREN 9 YEARS OF AGE AND OLDER AND ADULTS WITH PRIMARY HYPEROXALURIA TYPE 1 (PH1) AND RELATIVELY PRESERVED KIDNEY FUNCTION, E.G., EGFR GREATER THAN OR EQUAL TO 30 ML/MIN/1.73 M^2
EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION Sept. 29, 2030 TO LOWER URINARY OXALATE LEVELS IN CHILDREN 9 YEARS OF AGE AND OLDER AND ADULTS WITH PRIMARY HYPEROXALURIA TYPE 1 (PH1) AND RELATIVELY PRESERVED KIDNEY FUNCTION, E.G., EGFR GREATER THAN OR EQUAL TO 30 ML/MIN/1.73 M^2
EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION March 27, 2032 TO LOWER URINARY OXALATE LEVELS IN CHILDREN 2 TO LESS THAN 9 YEARS OF AGE WITH PRIMARY HYPEROXALURIA TYPE 1 (PH1) AND RELATIVELY PRESERVED KIDNEY FUNCTION, E.G., EGFR GREATER THAN OR EQUAL TO 30 ML/MIN/1.73 M2
EQ 160MG BASE/ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION March 27, 2032 TO LOWER URINARY OXALATE LEVELS IN CHILDREN 2 TO LESS THAN 9 YEARS OF AGE WITH PRIMARY HYPEROXALURIA TYPE 1 (PH1) AND RELATIVELY PRESERVED KIDNEY FUNCTION, E.G., EGFR GREATER THAN OR EQUAL TO 30 ML/MIN/1.73 M2
EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) RIVFLOZA NOVO N215842 Sept. 29, 2023 RX SOLUTION INJECTION March 27, 2032 TO LOWER URINARY OXALATE LEVELS IN CHILDREN 2 TO LESS THAN 9 YEARS OF AGE WITH PRIMARY HYPEROXALURIA TYPE 1 (PH1) AND RELATIVELY PRESERVED KIDNEY FUNCTION, E.G., EGFR GREATER THAN OR EQUAL TO 30 ML/MIN/1.73 M2

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
L-lactate dehydrogenase A chain mRNA RNA ANTISENSE INHIBITOR UNKNOWN DRUG LABEL
Asialoglycoprotein receptor 1 Membrane receptor BINDING AGENT UNKNOWN DRUG LABEL
Asialoglycoprotein receptor 2 Membrane receptor BINDING AGENT UNKNOWN DRUG LABEL

External reference:

IDSource
2266591-83-5 SECONDARY_CAS_RN
CHEBI:758150 CHEBI
CHEMBL4650244 ChEMBL_ID
C000723113 MESH_SUPPLEMENTAL_RECORD_UI
13615 IUPHAR_LIGAND_ID
4042917 VANDF
C5446775 UMLSCUI
CHEMBL4594338 ChEMBL_ID
11373 INN_ID
371760 MMSL
42026 MMSL
d10115 MMSL
019569 NDDF
019570 NDDF
13U9R5J3WL UNII
2675287 RXNORM
D12723 KEGG_DRUG

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
RIVFLOZA HUMAN PRESCRIPTION DRUG LABEL 1 0169-5306 INJECTION, SOLUTION 160 mg SUBCUTANEOUS NDA 24 sections
RIVFLOZA HUMAN PRESCRIPTION DRUG LABEL 1 0169-5307 INJECTION, SOLUTION 128 mg SUBCUTANEOUS NDA 24 sections
RIVFLOZA HUMAN PRESCRIPTION DRUG LABEL 1 0169-5308 INJECTION, SOLUTION 80 mg SUBCUTANEOUS NDA 24 sections