Nedosiran
Rivfloza (nedosiran) is an oligonucleotide pharmaceutical. Nedosiran was first approved as Rivfloza on 2023-09-29. It is used to treat primary hyperoxaluria in the USA.
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Commercial
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Trade Name
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Rivfloza
Drug Products
FDA
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nedosiran sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RIVFLOZA | Novo Nordisk | N-215842 RX | 2023-09-29 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| rivfloza | New Drug Application | 2023-09-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| primary hyperoxaluria | — | D006960 | E72.53 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
NEDOSIRAN SODIUM, RIVFLOZA, NOVO | |||
| 2030-09-29 | ODE-443 | ||
| 2028-09-29 | NCE | ||
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Clinical
Clinical Trials
6 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primary hyperoxaluria | D006960 | — | E72.53 | 1 | 3 | 1 | — | 1 | 6 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | 1 | — | — | 2 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | 1 | 1 | — | — | 2 |
| Urologic diseases | D014570 | — | N39.9 | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nedosiran |
| INN | nedosiran |
| Description | Nedosiran, sold under the brand name Rivfloza, is a medication used for the treatment of primary hyperoxaluria. It is an LDHA-directed small interfering RNA developed by Dicerna Pharmaceuticals.
|
| Classification | Oligonucleotide |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 2266591-83-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4650244 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB17635 |
| UNII ID | 13U9R5J3WL (ChemIDplus, GSRS) |
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Safety
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Adverse Events
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