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Drug ReportsInclisiran
Leqvio(inclisiran)
Leqvio (inclisiran) is an oligonucleotide pharmaceutical. Inclisiran was first approved as Leqvio on 2020-12-09. It is used to treat hypercholesterolemia in the USA. It has been approved in Europe to treat dyslipidemias and hypercholesterolemia.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Leqvio
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Inclisiran sodium
Tradename
Company
Number
Date
Products
LEQVIONovartisN-214012 RX2021-12-22
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
leqvioNew Drug Application2024-07-09
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypercholesterolemiaHP_0003124D006937
Agency Specific
FDA
EMA
Expiration
Code
INCLISIRAN SODIUM, LEQVIO, NOVARTIS
2026-12-22NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Inclisiran Sodium, Leqvio, Novartis
108513772036-08-25U-3652
101253692034-08-18DS, DPU-3652
81060222029-12-12DS, DPU-3652
88289562028-12-04DS, DPU-3652
93705822028-12-04DS, DPU-3652
108067912028-12-04DP
101319072028-08-24DS, DPU-3652
82222222027-12-29U-3652
88092922027-05-10DS, DPU-3652
115304082024-05-18DP
97086152024-03-08DP
102734772024-03-08DP
106695442024-03-08DP
ATC Codes
C: Cardiovascular system drugs
C10: Lipid modifying agents
C10A: Lipid modifying agents, plain
C10AX: Other lipid modifying agents in atc
C10AX16: Inclisiran
HCPCS
Code
Description
J1306
Injection, inclisiran, 1 mg
Clinical
No data
Drug
General
Drug common nameInclisiran
INNinclisiran
Description
Inclisiran, sold under the brand name Leqvio, is a medication used for the treatment of high low-density lipoprotein (LDL) cholesterol and for the treatment of people with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk-equivalents, and heterozygous familial hypercholesterolemia (HeFH). It is a small interfering RNA (siRNA) that acts as an inhibitor of a proprotein convertase, specifically, inhibiting translation of the protein PCSK9.
Classification
Oligonucleotide
Drug classAntilipemic agent
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID1639324-58-5
RxCUI
ChEMBL IDCHEMBL3990033
ChEBI ID
PubChem CID
DrugBankDB14901
UNII IDUOW2C71PG5 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Leqvio Novartis
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Estimated US medical usage
No data
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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