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 diseases | D009750 |
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 |
|---|---|---|---|---|
| LEQVIO | Novartis | N-214012 RX | 2021-12-22 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| leqvio | New Drug Application | 2021-12-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hypercholesterolemia | HP_0003124 | D006937 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
INCLISIRAN SODIUM, LEQVIO, NOVARTIS | |||
| 2026-12-22 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Inclisiran Sodium, Leqvio, Novartis | |||
| 10851377 | 2036-08-25 | U-3272 | |
| 10125369 | 2034-08-18 | DS, DP | U-3272 |
| 8106022 | 2029-12-12 | DS, DP | U-3272 |
| 8828956 | 2028-12-04 | DS, DP | U-3272 |
| 9370582 | 2028-12-04 | DS, DP | U-3272 |
| 10806791 | 2028-12-04 | DP | |
| 10131907 | 2028-08-24 | DS, DP | U-3272 |
| 8222222 | 2027-12-29 | U-3272 | |
| 8809292 | 2027-05-10 | DS, DP | U-3272 |
| 11530408 | 2024-05-18 | DP | |
| 9708615 | 2024-03-08 | DP | |
| 10273477 | 2024-03-08 | DP | |
| 10669544 | 2024-03-08 | DP | |
| 9708610 | 2024-01-01 | DS, DP | U-3272 |
| 10266825 | 2023-11-04 | U-3272 | |
| 11078485 | 2023-11-04 | DP | U-3272 |
| 8232383 | 2023-02-20 | DS, DP | |
HCPCS
No data
Clinical
Clinical Trials
36 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypercholesterolemia | D006937 | HP_0003124 | 1 | 1 | 6 | 1 | 4 | 13 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | 4 | 6 | — | 1 | 11 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | — | — | 1 |
| Heart disease risk factors | D000082742 | — | — | 1 | — | — | 1 | ||
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | 1 | — | — | 1 | |
| Coronary artery disease | D003324 | I25.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | — | — | 1 | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carotid stenosis | D016893 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | INCLISIRAN |
| INN | inclisiran |
| 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-ID | 1639324-58-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3990033 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14901 |
| UNII ID | UOW2C71PG5 (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:
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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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