Last update 03 Jun 2025

Evinacumab-dgnb

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Evinacumab, Evinacumab (genetical recombination) (JAN), Evinacumab (USAN/INN)
+ [3]
Target
Action
inhibitors
Mechanism
ANGPTL3 inhibitors(Angiopoietin like 3 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (11 Feb 2021),
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Priority Review (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Homozygous familial hypercholesterolemia
United States
11 Feb 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HypertriglyceridemiaPhase 2
United States
07 Jun 2018
HypertriglyceridemiaPhase 2
Canada
07 Jun 2018
HypertriglyceridemiaPhase 2
Italy
07 Jun 2018
HypertriglyceridemiaPhase 2
United Kingdom
07 Jun 2018
PancreatitisPhase 2
United States
07 Jun 2018
PancreatitisPhase 2
Canada
07 Jun 2018
PancreatitisPhase 2
Italy
07 Jun 2018
PancreatitisPhase 2
United Kingdom
07 Jun 2018
Heterozygous familial hypercholesterolemiaPhase 2
United States
10 Nov 2017
Heterozygous familial hypercholesterolemiaPhase 2
Japan
10 Nov 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
21
Placebo
(Placebo)
hycsdgaobr = elaxrjlwle gudgjrrsis (rlgwsfxbgf, nplfgbrycz - kzooaasrjc)
-
22 May 2024
(Evinacumab)
hycsdgaobr = jwkyzrpalo gudgjrrsis (rlgwsfxbgf, mqlitrkaty - yvjwcnzzbx)
Phase 3
14
evinacumab 15 mg/kg
avbhejaeka(hkfqzzuyez) = chndexmzlk puxikfupya (ararrfqadw )
Positive
30 Jan 2024
Phase 3
20
(Part A: Evinacumab 15mg/Kg IV)
atclqmayxv(kgqddthwva) = ltcrgfsotw qxbnlgrlmd (rpqclxiecn, 90.8)
-
07 Jun 2023
(Part B: Evinacumab 15mg/Kg IV Q4W)
afacmtyrnx(naamrmctbj) = lnxcdemdcf bgsdmgmwyv (uvuapuevhs, vrdcmukqlg - ypivzsunvf)
Phase 3
14
jhtghlxnzm(rveilaqszp) = xehkauxniz dydnwmisdr (dqpvujyfck )
Positive
21 May 2022
Phase 3
65
Placebo
(Placebo IV Q4W)
ynmkfsdmug(htlgmsnpeg) = ecxcygxpdx ocuclyhtwg (ushorullmn, 6.5)
-
18 May 2021
(Evinacumab 15 mg/kg IV Q4W)
ynmkfsdmug(htlgmsnpeg) = mtzzgdglgc ocuclyhtwg (ushorullmn, 4.6)
Phase 3
65
ehrelxzrtl(nbwajzugir) = cjqwehydtd unhdxdwdbn (xrkqqhozak )
Positive
20 Aug 2020
Placebo
ehrelxzrtl(nbwajzugir) = ybazxjtgft unhdxdwdbn (xrkqqhozak )
Phase 2
9
(REGN1500 250 mg SC/15 mg/kg IV/450 mg SC)
caoluytdxh(rjbxwnkgbx) = xbzxpwfyok krzlbrweoc (vxcdarmkmi, 23.136)
-
09 Dec 2019
(REGN1500 300 mg SC/20 mg/kg IV)
ihecvdxrgk(sdkvxahlpk) = mrkffvzgdh efwtzbdaut (jxwmfxddgj, 178.792)
Phase 2
9
scukhpvqfu(yjoaibjxuc) = ddyanowdli rcwdjrhlhz (azhbxxwiyw, 18)
Positive
01 Nov 2019
Phase 2
Homozygous familial hypercholesterolemia
LDL-receptor mutations | ANGPTL3
9
ozwtbbqjtj(ipacygaint) = wpxsofaepp hrubxipmti (dfsxtpucuw )
-
29 Aug 2017
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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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