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| Stem definition | Drug id | CAS RN |
|---|---|---|
| small interfering RNA including siRNA, miRNA and piRNA | 5746 | 2247026-22-6 |
| Molecule | Description |
|---|---|
|
Synonyms:
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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.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 29, 2023 | FDA | NOVO NORDISK INC |
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| Source | Code | Description |
|---|---|---|
| ATC | A16AX25 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Various alimentary tract and metabolism products |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Primary hyperoxaluria, type I | indication | 65520001 | DOID:0111670 |
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| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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) |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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 |
| ID | Source |
|---|---|
| 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 |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |