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Drug ReportsAlirocumab
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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Variants
Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
nutritional and metabolic diseasesD009750
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
PraluentalirocumabRegeneron PharmaceuticalsN-125559 RX2015-07-24
2 products
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
praluentBiologic Licensing Application2024-09-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypercholesterolemia—D006937—
atherosclerosisEFO_0003914D050197I25.1
Agency Specific
FDA
EMA
Expiration
Code
alirocumab, Praluent, Regeneron Pharmaceuticals, Inc.
2028-04-01Orphan excl.
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C10: Lipid modifying agents
— C10A: Lipid modifying agents, plain
— C10AX: Other lipid modifying agents in atc
— C10AX14: Alirocumab
HCPCS
No data
Clinical
Clinical Trials
105 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypercholesterolemiaD006937——108254148
Hyperlipoproteinemia type iiD006938EFO_0004911E78.00—381—12
AtherosclerosisD050197EFO_0003914I25.11—12—4
DyslipidemiasD050171———1—2—3
Atherosclerotic plaqueD058226HP_0031678I70——12—3
Myocardial infarctionD009203EFO_0000612I21———2—2
InfarctionD007238EFO_0009463————2—2
HyperlipidemiasD006949EFO_0003774E78.5——11—2
SyndromeD013577———1—1—2
Acute coronary syndromeD054058EFO_0005672———11—2
Show 2 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Homozygous familial hypercholesterolemiaD000090542————2——2
Peritoneal dialysisD010530————1——1
Carotid artery diseasesD002340EFO_0003781———1——1
Renal dialysisD006435EFO_0010690Z99.2——1——1
Type 2 diabetes mellitusD003924EFO_0001360E11——1——1
Diabetes mellitusD003920EFO_0000400E08-E13——1——1
Coronary circulationD003326————1——1
Cardiovascular diseasesD002318EFO_0000319I98——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289———2———2
Lung neoplasmsD008175—C34.90—2———2
Nephrotic syndromeD009404EFO_0004255N04—1———1
NephrosisD009401———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
HemorrhageD006470MP_0001914R581————1
StrokeD020521EFO_0000712I63.91————1
Intracranial arteriosclerosisD002537EFO_1000860I67.21————1
SepsisD018805EFO_0001420A41.91————1
ToxemiaD014115——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAlirocumab
INNalirocumab
Description
Alirocumab (human mab)
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2109540
ChEBI ID—
PubChem CID—
DrugBankDB09302
UNII IDPP0SHH6V16 (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 3,766 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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20,114 adverse events reported
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