Praluent(alirocumab)
Praluent (alirocumab) is an antibody pharmaceutical. Alirocumab was first approved as Praluent on 2015-07-24. It is used to treat atherosclerosis and hypercholesterolemia in the USA. It has been approved in Europe to treat dyslipidemias. The pharmaceutical is active against proprotein convertase subtilisin/kexin type 9.
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YTD
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Praluent (discontinued: Praluent)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Alirocumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Praluent | alirocumab | Regeneron Pharmaceuticals | N-125559 RX | 2015-07-24 | 2 products |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| praluent | Biologic Licensing Application | 2025-09-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hypercholesterolemia | — | D006937 | — |
| atherosclerosis | EFO_0003914 | D050197 | I25.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
alirocumab, Praluent, Regeneron Pharmaceuticals, Inc. | |||
| 2028-04-01 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
107 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 | — | — | 10 | 7 | 24 | 5 | 2 | 48 |
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | 2 | 6 | 1 | — | 9 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | 1 | 1 | 3 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | 1 | 1 | 1 | 3 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | — | 1 | 1 | 1 | 3 |
| Dyslipidemias | D050171 | — | — | — | — | — | 1 | 1 | 2 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | — | — | 1 | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 1 | — | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | 1 | — | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Homozygous familial hypercholesterolemia | D000090542 | — | — | — | — | 2 | — | — | 2 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | 1 | 1 | — | — | 1 |
| Septic shock | D012772 | — | A48.3 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Alirocumab |
| INN | alirocumab |
| Description | Alirocumab (human mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2109540 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09302 |
| UNII ID | PP0SHH6V16 (ChemIDplus, GSRS) |
Target
Agency Approved
PCSK9
PCSK9
Organism
Homo sapiens
Gene name
PCSK9
Gene synonyms
NARC1
NCBI Gene ID
Protein name
proprotein convertase subtilisin/kexin type 9
Protein synonyms
convertase subtilisin/kexin type 9 preproprotein, NARC-1, neural apoptosis regulated convertase 1, Neural apoptosis-regulated convertase 1, PC9, Proprotein convertase 9, Subtilisin/kexin-like protease PC9
Uniprot ID
Mouse ortholog
Pcsk9 (100102)
proprotein convertase subtilisin/kexin type 9 (Q8CFT6)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Praluent – Regeneron Pharmaceuticals
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Praluent – Sanofi
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,214 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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20,605 adverse events reported
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