Givlaari(givosiran)
Givlaari (givosiran) is an oligonucleotide pharmaceutical. Givosiran was first approved as Givlaari on 2019-11-20. It has been approved in Europe to treat hepatic porphyrias.
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Commercial
Trade Name
FDA
EMA
Givlaari
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Givosiran sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GIVLAARI | Alnylam Pharmaceuticals | N-212194 RX | 2019-11-20 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| givlaari | New Drug Application | 2024-04-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hepatic porphyrias | — | D017094 | — |
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 | |
HCPCS
Code | Description |
|---|---|
| J0223 | Injection, givosiran, 0.5 mg |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Erythropoietic porphyria | D017092 | — | E80.0 | 3 | 1 | 1 | — | 2 | 6 |
| Porphyrias | D011164 | EFO_0000665 | — | 3 | 1 | 1 | — | 2 | 6 |
| Acute intermittent porphyria | D017118 | — | — | 3 | 1 | 1 | — | — | 4 |
| Hereditary coproporphyria | D046349 | — | E80.29 | 1 | — | 1 | — | 2 | 4 |
| Hepatic porphyrias | D017094 | — | — | 1 | — | 1 | — | 2 | 4 |
| Variegate porphyria | D046350 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Givosiran |
| INN | givosiran |
| Description | Givosiran, sold under the brand name Givlaari, is a medication used for the treatment of adults with acute hepatic porphyria. Givosiran is a small interfering RNA (siRNA) directed towards delta-aminolevulinate synthase 1 (ALAS1), an important enzyme in the production of heme.
|
| Classification | Oligonucleotide |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1639325-43-1 |
| RxCUI | 2265712 |
| ChEMBL ID | CHEMBL4297760 |
| ChEBI ID | — |
| PubChem CID | 119058042 |
| DrugBank | DB15066 |
| UNII ID | ROV204583W (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Givlaari – Alnylam Pharmaceuticals
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Trends
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Additional graphs summarizing 761 documents
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Safety
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Adverse Events
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801 adverse events reported
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