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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
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 | 2021-05-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| atherosclerosis | EFO_0003914 | D050197 | I25.1 |
| hypercholesterolemia | HP_0003124 | D006937 | — |
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
101 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 | — | 10 | 9 | 23 | 4 | 5 | 51 |
| Dyslipidemias | D050171 | HP_0003119 | — | — | 1 | 1 | 3 | 4 | 9 |
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | 1 | 3 | 2 | 1 | 7 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 1 | — | — | 3 | 3 | 7 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 2 | 1 | 2 | 5 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | 1 | — | 1 | 3 | 5 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | — | 1 | — | 2 | — | 3 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | 2 | 1 | 3 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | 2 | — | 2 |
| Angina pectoris | D000787 | EFO_0003913 | I20 | — | — | — | 1 | — | 1 |
Show 3 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | HP_0100806 | A41.9 | 1 | 1 | 1 | — | — | 2 |
| Atherosclerotic plaque | D058226 | HP_0031678 | I70 | — | — | 2 | — | — | 2 |
| Septic shock | D012772 | — | A48.3 | — | 1 | 1 | — | — | 1 |
| Peritoneal dialysis | D010530 | — | — | — | — | 1 | — | — | 1 |
| Carotid artery diseases | D002340 | EFO_0003781 | — | — | — | 1 | — | — | 1 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | 1 | — | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 1 | — | — | 1 |
| Homozygous familial hypercholesterolemia | D000090542 | — | — | — | — | 1 | — | — | 1 |
| Coronary circulation | D003326 | — | — | — | — | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intracranial arteriosclerosis | D002537 | EFO_1000860 | I67.2 | 1 | 1 | — | — | — | 2 |
| Ischemic stroke | D000083242 | — | — | — | 1 | — | — | 1 | 2 |
| St elevation myocardial infarction | D000072657 | — | — | — | 1 | — | — | — | 1 |
| Nephrotic syndrome | D009404 | EFO_0004255 | N04 | — | 1 | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | — | — | — | 1 | 2 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | — | — | — | — | 1 |
| Coronary disease | D003327 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Genetic testing | D005820 | — | — | — | — | — | — | 1 | 1 |
| Hyperlipoproteinemia type iii | D006952 | — | — | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
| Treatment adherence and compliance | D000074822 | — | — | — | — | — | — | 1 | 1 |
| Patient compliance | D010349 | — | — | — | — | — | — | 1 | 1 |
| Motivational interviewing | D062405 | — | — | — | — | — | — | 1 | 1 |
| Compliance | D003187 | — | — | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Genetic polymorphism | D011110 | — | — | — | — | — | — | 1 | 1 |
| Cognition | D003071 | EFO_0003925 | — | — | — | — | — | 1 | 1 |
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
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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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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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16,020 adverse events reported
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