Givosiran sodium
Givlaari (givosiran sodium) is an oligonucleotide pharmaceutical. Givosiran sodium was first approved as Givlaari on 2019-11-20. It has been approved in Europe to treat hepatic porphyrias.
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Abbreviated New Drug Application (ANDA)
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| givlaari | New Drug Application | 2025-09-10 |
Indications
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
GIVOSIRAN SODIUM, GIVLAARI, ALNYLAM PHARMS INC | |||
| 2026-11-20 | ODE-273 | ||
| 2024-11-20 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Givosiran Sodium, Givlaari, Alnylam Pharms Inc | |||
| 10119143 | 2034-10-03 | DS, DP | U-2672 |
| 11028392 | 2034-10-03 | DS, DP | U-2672 |
| 9133461 | 2033-11-30 | DS, DP | U-2672 |
| 9631193 | 2033-03-15 | U-2672 | |
| 10125364 | 2033-03-15 | DS, DP | U-2672 |
| 8106022 | 2029-12-12 | DS, DP | U-2672 |
| 8828956 | 2028-12-04 | DS, DP | U-2672 |
| 10131907 | 2028-08-24 | DS, DP | U-2672 |
| 9150605 | 2025-08-28 | DS, DP | |
| 11530408 | 2024-05-18 | DS, DP | |
| 9708615 | 2024-03-08 | DP | |
| 10273477 | 2024-03-08 | DP | |
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Clinical Trials
2 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute intermittent porphyria | D017118 | — | — | 1 | 1 | 1 | — | — | 2 |
| Erythropoietic porphyria | D017092 | — | — | 1 | 1 | 1 | — | — | 2 |
| Porphyrias | D011164 | EFO_0000665 | — | 1 | 1 | 1 | — | — | 2 |
| Hereditary coproporphyria | D046349 | — | E80.29 | — | — | 1 | — | — | 1 |
| Variegate porphyria | D046350 | — | — | — | — | 1 | — | — | 1 |
| Hepatic porphyrias | D017094 | — | — | — | — | 1 | — | — | 1 |
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Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Givosiran sodium |
| INN | givosiran |
| Description | Givlaari (givosiran sodium) is an oligonucleotide pharmaceutical. Givosiran sodium was first approved as Givlaari on 2019-11-20. It has been approved in Europe to treat hepatic porphyrias. |
| Classification | Oligonucleotide |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4594265 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | ROV204583W (ChemIDplus, GSRS) |
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Givlaari – Alnylam Pharmaceuticals
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Safety
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1,176 adverse events reported
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