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Givlaari(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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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
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
GIVLAARIAlnylam PharmaceuticalsN-212194 RX2019-11-20
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
givlaariNew Drug Application2021-01-04
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
GIVOSIRAN SODIUM, GIVLAARI, ALNYLAM PHARMS INC
2026-11-20ODE-273
2024-11-20NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Givosiran Sodium, Givlaari, Alnylam Pharms Inc
101191432034-10-03DS, DPU-2672
110283922034-10-03DS, DPU-2672
91334612033-11-30DS, DPU-2672
96311932033-03-15U-2672
101253642033-03-15DS, DPU-2672
81060222029-12-12DS, DPU-2672
88289562028-12-04DS, DPU-2672
101319072028-08-24DS, DPU-2672
91506052025-08-28DS, DP
115304082024-05-18DS, DP
97086152024-03-08DP
102734772024-03-08DP
97086102024-01-01DS, DPU-2672
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AX: Various alimentary tract and metabolism products
— A16AX16: Givosiran
HCPCS
No data
Clinical
Clinical Trials
5 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acute intermittent porphyriaD017118311——4
Hepatic porphyriasD0170941—1—13
Hereditary coproporphyriaD046349E80.29——1——1
Variegate porphyriaD046350——1——1
Indications Phases 2
No data
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 nameGIVOSIRAN SODIUM
INNgivosiran
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 IDCHEMBL4594265
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDROV204583W (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Givlaari - Alnylam Pharmaceuticals
$
€
£
₣
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Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 568 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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