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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 Application2021-12-22
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-3272
101253692034-08-18DS, DPU-3272
81060222029-12-12DS, DPU-3272
88289562028-12-04DS, DPU-3272
93705822028-12-04DS, DPU-3272
108067912028-12-04DP
101319072028-08-24DS, DPU-3272
82222222027-12-29U-3272
88092922027-05-10DS, DPU-3272
115304082024-05-18DP
97086152024-03-08DP
102734772024-03-08DP
106695442024-03-08DP
97086102024-01-01DS, DPU-3272
102668252023-11-04U-3272
110784852023-11-04DPU-3272
82323832023-02-20DS, DP
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
No data
Clinical
Clinical Trials
36 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypercholesterolemiaD006937HP_00031241161413
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hyperlipoproteinemia type iiD006938EFO_0004911E78.0046111
Cardiovascular diseasesD002318EFO_0000319I9811
Heart disease risk factorsD00008274211
Acute coronary syndromeD054058EFO_000567211
Coronary artery diseaseD003324I25.111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AtherosclerosisD050197EFO_0003914I25.1112
Type 2 diabetes mellitusD003924EFO_0001360E1111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperlipidemiasD006949EFO_0003774E78.511
Renal insufficiencyD051437HP_0000083N1911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Carotid stenosisD01689311
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameINCLISIRAN
INNinclisiran
Description
Inclisiran, sold under the brand name Leqvio, is a medication 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 class
Image (chem structure or protein)
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
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 879 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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