Last update 28 Jan 2026

Evolocumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Evolocumab (Genetical Recombination), Evolocumab (genetical recombination) (JAN), Evolocumab (USAN/INN)
+ [4]
Target
Action
inhibitors
Mechanism
PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D10557Evolocumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Coronary Disease
China
14 Feb 2019
Hypercholesterolemia
Japan
22 Jan 2016
Hypercholesterolemia, Familial
Japan
22 Jan 2016
Heterozygous familial hypercholesterolemia
United States
27 Aug 2015
Primary Hyperlipidemia
United States
27 Aug 2015
Atherosclerosis
European Union
17 Jul 2015
Atherosclerosis
Iceland
17 Jul 2015
Atherosclerosis
Liechtenstein
17 Jul 2015
Atherosclerosis
Norway
17 Jul 2015
Complex dyslipidemia
European Union
17 Jul 2015
Complex dyslipidemia
Iceland
17 Jul 2015
Complex dyslipidemia
Liechtenstein
17 Jul 2015
Complex dyslipidemia
Norway
17 Jul 2015
Homozygous familial hypercholesterolemia
European Union
17 Jul 2015
Homozygous familial hypercholesterolemia
Iceland
17 Jul 2015
Homozygous familial hypercholesterolemia
Liechtenstein
17 Jul 2015
Homozygous familial hypercholesterolemia
Norway
17 Jul 2015
Myocardial Infarction
European Union
17 Jul 2015
Myocardial Infarction
Iceland
17 Jul 2015
Myocardial Infarction
Liechtenstein
17 Jul 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Calcification of coronary arteryPhase 3
United States
19 Mar 2019
Coronary Artery DiseasePhase 3
United States
19 Nov 2018
Coronary Artery DiseasePhase 3
Australia
19 Nov 2018
Coronary Artery DiseasePhase 3
Czechia
19 Nov 2018
Coronary Artery DiseasePhase 3
Germany
19 Nov 2018
Coronary Artery DiseasePhase 3
Hungary
19 Nov 2018
Coronary Artery DiseasePhase 3
Italy
19 Nov 2018
Coronary Artery DiseasePhase 3
Netherlands
19 Nov 2018
Acute Coronary SyndromePhase 3
Switzerland
23 Jan 2018
ArteritisPhase 3
United States
14 Apr 2016
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
5,291
kkwghbhvpq(niozlghapk): IRR = 0.69 (95.0% CI, 0.57 - 0.84)
Positive
13 Jan 2026
-
Not Applicable
110,000
uxddkmzzwm(ghdcoefheb): RR = 0.8 (95.0% CI, 0.73 - 0.86); Difference (%) = -20
Positive
25 Nov 2025
Not treated with Repatha
Phase 2
60
(Evolocumab)
elmrbmprky(pibpfbxfjc) = ytewqalcaz rovyoobnyg (vbonsthfgu, gdoplzhkdz - ajaurzuomv)
-
24 Nov 2025
Placebo
(Placebo)
elmrbmprky(pibpfbxfjc) = rgadkfhgve rovyoobnyg (vbonsthfgu, enrhorfjtt - mxsburycke)
Phase 3
12,257
Evolocumab 140 mg
jhlfjxstug(gxibsjldyd) = gthorqcxet haocharihk (axcrkqsgqn )
Positive
08 Nov 2025
Placebo
jhlfjxstug(gxibsjldyd) = kgvgbgpbog haocharihk (axcrkqsgqn )
Phase 3
12,257
yiqvhzjtqu(vujulqqmtf) = munolrplrl bjdvttxmnp (hgchpktjjg )
Positive
08 Nov 2025
Placebo
yiqvhzjtqu(vujulqqmtf) = kcqbwdtitx bjdvttxmnp (hgchpktjjg )
Phase 2
100
(Evolocumab)
oneapfetni(yqfvvpmumg) = ceymuyrhyw eakvdjoknh (ssluzirxqg, oltianwrvf - mnavwcxfol)
-
23 Oct 2025
Placebos
(Placebo)
oneapfetni(yqfvvpmumg) = yuioldjlwb eakvdjoknh (ssluzirxqg, xiefpausvq - rirqnhzxhz)
Phase 3
-
-
Repatha + Standard therapy
krwhriehih(jeljdehrjl) = The results show that the primary endpoints were both statistically and clinically significant. qrqfxqzgoy (myqbdmvqau )
Met
Positive
02 Oct 2025
Placebo + Standard therapy
Phase 3
150
nusytvyxen(opxnxfmimu) = spptcgepcq njuddpifyt (gynlzquqtb, -0.02 to 0.02)
Negative
01 Aug 2025
Placebo
nusytvyxen(opxnxfmimu) = iadwtxvkhe njuddpifyt (gynlzquqtb, -0.01 to 0.03)
Phase 3
197
mubkesjvjo(jxuxaphdbx) = tblaqnspcu zhbqfvauzh (qbytaxamgl )
Positive
20 Jun 2025
Placebo
-
Phase 3
-
wjvpayzsrf(bdrvgnspaq) = phgsnhlvhr jllkcuzssq (rkijxpztum, 79.5 - 105.5)
Positive
20 May 2025
Placebo
wjvpayzsrf(bdrvgnspaq) = rmbipzrtzr jllkcuzssq (rkijxpztum, 79.5 - 108.5)
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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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