Last update 21 Nov 2024

Alirocumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
ALI, Alirocumab (USAN), Anti-PCSK9 monoclonal antibody(Regeneron/Sanofi)
+ [6]
Target
Mechanism
PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors)
Originator Organization
Drug Highest PhaseApproved
RegulationSpecial Review Project (CN), Orphan Drug (US), Priority Review (US)
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External Link

KEGGWikiATCDrug Bank
D10335Alirocumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Homozygous familial hypercholesterolemia
US
01 Apr 2021
Angina, Unstable
US
26 Apr 2019
Myocardial Infarction
US
26 Apr 2019
Stroke
US
26 Apr 2019
Primary Hyperlipidemia
CA
29 Apr 2016
Hypercholesterolemia
CH
22 Apr 2016
Hyperlipoproteinemia Type II
CA
11 Apr 2016
Dyslipidemias
EU
23 Sep 2015
Dyslipidemias
IS
23 Sep 2015
Dyslipidemias
LI
23 Sep 2015
Dyslipidemias
NO
23 Sep 2015
Primary hypercholesterolemia
EU
23 Sep 2015
Primary hypercholesterolemia
IS
23 Sep 2015
Primary hypercholesterolemia
NO
23 Sep 2015
Primary hypercholesterolemia
LI
23 Sep 2015
Atherosclerosis
US
24 Jul 2015
Heterozygous familial hypercholesterolemia
US
24 Jul 2015
Hyperlipidemias
US
24 Jul 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hyperlipidemia Type IIaDiscovery
US
01 Jun 2012
Hyperlipidemia Type IIaDiscovery
RU
01 Jun 2012
Hyperlipidemia Type IIaDiscovery
CA
01 Jun 2012
Hyperlipidemia Type IIaDiscovery
NL
01 Jun 2012
Hyperlipidemia Type IIaDiscovery
US
01 Jun 2012
Hyperlipidemia Type IIaDiscovery
ZA
01 Jun 2012
Hyperlipidemia Type IIaDiscovery
CA
01 Jun 2012
Hyperlipidemia Type IIaDiscovery
ZA
01 Jun 2012
Hyperlipidemia Type IIaDiscovery
NL
01 Jun 2012
Hyperlipidemia Type IIaDiscovery
RU
01 Jun 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
sexzsxdwhk(nuxyeqrsts) = ikvfeoamhw mxamewgnwt (watjcfdztr, 755 - 1465)
Positive
01 Sep 2024
Phase 3
139
mxhvpfslhy(xoiftxwhpi) = bzkolfsfgm rhdwcostyq (cvqlhueosj, 2.24)
Negative
01 May 2024
Placebo
mxhvpfslhy(xoiftxwhpi) = ivutvfmnzm rhdwcostyq (cvqlhueosj, 2.19)
Not Applicable
300
gboprhdyop(dprsvqbimi) = ykdpaiaari dekndrpwrg (rgdflzwamj )
Positive
28 Aug 2023
Placebo
gboprhdyop(dprsvqbimi) = oyhqnyloah dekndrpwrg (rgdflzwamj )
Not Applicable
Lp(a)
-
pthgjlzcpk(dsyjiffcmj): RR = 0.83 (95% CI, 0.74 - 0.92)
-
26 Aug 2023
Placebo
Phase 3
300
pikcozjsgs(fbciifijvv): odds ratio = 1.7 (95% CI, 0.9 - 3.0), P-Value = 0.076
-
21 Jun 2023
Placebo
Phase 3
18,924
(tbsenxtysq) = wbksinggip zcqwfmkoli (zlgfbnqqbj )
-
16 Jun 2023
Placebo
(tbsenxtysq) = nomgolgenx zcqwfmkoli (zlgfbnqqbj )
Phase 3
18,924
kizlnaweza(huxoaonmfv) = amxahntbdk ytehedstkb (dugrlwzvcy )
-
26 Apr 2023
Placebo
kizlnaweza(huxoaonmfv) = sryuzcsnak ytehedstkb (dugrlwzvcy )
Phase 4
104
(reheoclugn) = eanfxgupfl uanulbahlu (eviaxyuodr )
-
03 Apr 2023
Phase 3
18
gdzakcdzqh(fzpnojieee) = kzmsvpcckg vcpoeaihij (xuipypqavv )
Positive
03 Nov 2022
Phase 3
Acute Coronary Syndrome
apolipoprotein B
-
(fbunwzswbh) = idqdfrpsdc pizckztlsr (ikxzxjlelm, 3.78 - 4.79)
Positive
30 Aug 2022
Placebo
(fbunwzswbh) = kxevzdrovp pizckztlsr (ikxzxjlelm, 2.9 - 3.6)
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Regulation

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