Last update 08 May 2025

Alirocumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
ALI, Alirocumab (USAN), Anti-PCSK9 monoclonal antibody(Regeneron/Sanofi)
+ [6]
Target
Action
inhibitors
Mechanism
PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationSpecial Review Project (China), Orphan Drug (United States), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D10335Alirocumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Homozygous familial hypercholesterolemia
United States
01 Apr 2021
Dyslipidemias
China
26 Dec 2019
Angina, Unstable
United States
26 Apr 2019
Myocardial Infarction
United States
26 Apr 2019
Stroke
United States
26 Apr 2019
Primary Hyperlipidemia
Canada
29 Apr 2016
Hypercholesterolemia
Switzerland
22 Apr 2016
Hyperlipoproteinemia Type II
Canada
11 Apr 2016
Complex dyslipidemia
Iceland
23 Sep 2015
Complex dyslipidemia
European Union
23 Sep 2015
Complex dyslipidemia
Liechtenstein
23 Sep 2015
Complex dyslipidemia
Norway
23 Sep 2015
Primary hypercholesterolemia
Iceland
23 Sep 2015
Primary hypercholesterolemia
Liechtenstein
23 Sep 2015
Primary hypercholesterolemia
European Union
23 Sep 2015
Primary hypercholesterolemia
Norway
23 Sep 2015
Atherosclerosis
United States
24 Jul 2015
Heterozygous familial hypercholesterolemia
United States
24 Jul 2015
Hyperlipidemias
United States
24 Jul 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HypercholesterolemiaDiscovery
Finland
01 Jan 2012
HypercholesterolemiaDiscovery
Belgium
01 Jan 2012
HypercholesterolemiaDiscovery
Argentina
01 Jan 2012
HypercholesterolemiaDiscovery
Poland
01 Jan 2012
HypercholesterolemiaDiscovery
Romania
01 Jan 2012
HypercholesterolemiaDiscovery
South Africa
01 Jan 2012
HypercholesterolemiaDiscovery
Mexico
01 Jan 2012
HypercholesterolemiaDiscovery
Spain
01 Jan 2012
HypercholesterolemiaDiscovery
Denmark
01 Jan 2012
HypercholesterolemiaDiscovery
Italy
01 Jan 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Acute Coronary Syndrome
atherogenic lipoprotein levels | low-density lipoprotein cholesterol (LDL-C)
-
npshmzeteo(efduacnlfv) = rgkdehfixt yarluzhbvi (dgdnxobmub, 0.845 - 0.998)
Positive
01 Dec 2024
Placebo
-
Phase 3
-
ifikiieoav(kgpzmbidoh) = srkchlajsk rehnqqhxro (dpcavmwnwt, 755 - 1465)
Positive
01 Sep 2024
Not Applicable
300
kflcowikoz(suapxrekrh) = bvocozcnrv axahmjadgy (jjlaoysmdz )
Positive
28 Aug 2023
Placebo
kflcowikoz(suapxrekrh) = mupcgvwuyq axahmjadgy (jjlaoysmdz )
Phase 3
300
sooccgtbcb(yehknjjksv): odds ratio = 1.7 (95% CI, 0.9 - 3.0), P-Value = 0.076
-
21 Jun 2023
Placebo
Phase 3
18,924
rnujpbpdug(jkxgtzebfi) = wsnnzptttg sorvxbpqsc (rphkdhqort )
-
16 Jun 2023
Placebo
rnujpbpdug(jkxgtzebfi) = umqcqzbzwl sorvxbpqsc (rphkdhqort )
Phase 4
104
(yvjujxcpto) = hacgwyytmo soxfhzmjck (etezegkceh )
-
09 May 2023
Phase 3
18,924
syleelduut(pikarcuksw) = kqubpoynng ijxsfgbueh (wqavqgaxdl )
-
26 Apr 2023
Placebo
syleelduut(pikarcuksw) = sksalnjtte ijxsfgbueh (wqavqgaxdl )
Phase 3
18
nnldjluqhv(vmfkymqbqx) = jsvqybybyh tohsvgozel (wdvoikyeyl )
Positive
03 Nov 2022
Phase 3
Acute Coronary Syndrome
apolipoprotein B
-
(svwolpglty) = bnwbbldick snavqcswlv (bgqcymgpdf, 3.78 - 4.79)
Positive
30 Aug 2022
Placebo
(svwolpglty) = dhaeebwtyr snavqcswlv (bgqcymgpdf, 2.9 - 3.6)
Phase 3
139
pckpbcayke(lqudqrphwq) = ursvvbgzfi afvkibfvvn (efsaewpzaa, 2.24)
Negative
29 Aug 2022
Placebo
pckpbcayke(lqudqrphwq) = qnyigsunlo afvkibfvvn (efsaewpzaa, 2.19)
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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