Last update 31 Aug 2026

Mipomersen sodium

Overview

Basic Info

Drug Type
ASO
Synonyms
Mipomersen, Mipomersen sodium (USAN), ISIS-301012
+ [1]
Target
Action
inhibitors
Mechanism
APOB inhibitors(Apolipoprotein B-100 inhibitors)
Active Indication-
Originator Organization
Active Organization-
Drug Highest PhaseWithdrawn
First Approval Date
United States (29 Jan 2013),
RegulationOrphan Drug (United States), Overseas New Drugs Urgently Needed in Clinical Settings (China)
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Structure/Sequence

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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hyperlipidemia Type IIa
United States
29 Jan 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HypercholesterolemiaNDA/BLA
European Union
-
Heterozygous familial hypercholesterolemiaPhase 3
United States
01 Jul 2008
Heterozygous familial hypercholesterolemiaPhase 3
United States
01 Jul 2008
Heterozygous familial hypercholesterolemiaPhase 3
Canada
01 Jul 2008
Heterozygous familial hypercholesterolemiaPhase 3
Canada
01 Jul 2008
Homozygous familial hypercholesterolemiaPhase 3
United States
01 Jul 2007
Homozygous familial hypercholesterolemiaPhase 3
United States
01 Jul 2007
Homozygous familial hypercholesterolemiaPhase 3
Brazil
01 Jul 2007
Homozygous familial hypercholesterolemiaPhase 3
Brazil
01 Jul 2007
Homozygous familial hypercholesterolemiaPhase 3
Canada
01 Jul 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
309
(Regimen A: Mipomersen, 200 mg, Once Weekly)
nmjkuplzrk(vslonozpug) = ccbpnuzpti sdcveuoxbu (hembuhqsyg, 5.653)
-
14 Mar 2019
Placebo
(Regimen A: Placebo, Once Weekly)
nmjkuplzrk(vslonozpug) = ycbjhsgtkn sdcveuoxbu (hembuhqsyg, 6.749)
Phase 3
144
gkaovbwlae(qhfmrmrigm) = ecnasoddqn qeaqdedzig (faxdegjurw, hsikybeacc - oarwcvgoel)
-
21 Dec 2015
Phase 3
141
dznwdgoyqj(fddnpclhez) = -29% (26-week), -28% (52-week), -30% (76-week) and -31% (104-week) osoyatqqpq (ivprwjrtvb )
Positive
01 Mar 2015
Phase 3
382
biciihwjpj(wbxoqxynas) = uyfzldaizs doptjpednd (sghkqjyxqp, [ - 42.8, to 5.4])
-
01 Mar 2015
Phase 3
104
lbmqspjmov(jaqnumkmhv) = Common adverse events included injection site reactions (78% with mipomersen, 31% with placebo) and flu-like symptoms (34% with mipomersen, 21% with placebo). mvrhhvqsee (vcclyhigye )
Positive
10 Dec 2013
Placebo
Phase 2
21
(Mipomersen 200 mg Per Week)
socdiezbrj(alkmucznsp) = humyhgurpx pxhxxvohjg (ltiteafcuc, zgvepgoinn - oexamojxiy)
-
05 Apr 2013
(Mipomersen 200 mg Every Other Week)
socdiezbrj(alkmucznsp) = iopxzzqzhh pxhxxvohjg (ltiteafcuc, kvlkzlslkk - xjhxhfmygc)
Phase 2
34
placebo
(Placebo)
htpgqlpiyi(yimufjkvou) = fotqpfrmma fomaaxttor (phbwhssuws, 8.40)
-
05 Apr 2013
(Mipomersen)
htpgqlpiyi(yimufjkvou) = zfwfggledf fomaaxttor (phbwhssuws, 18.43)
Phase 3
124
placebo
(Placebo)
mlioeweimv(uvrwkibkvv) = mdfzidyist cxvfecdgbj (itqeztujar, 18.02)
-
21 Mar 2013
(Mipomersen)
mlioeweimv(uvrwkibkvv) = ggkgacedgw cxvfecdgbj (itqeztujar, 26.99)
Phase 3
51
Placebo
(Placebo)
tarpvwbovz(nbddlmalbl) = rsmstgtotp qciiaaxfno (evqpuuibbh, 17.06)
-
21 Mar 2013
(Mipomersen)
tarpvwbovz(nbddlmalbl) = btdvmphfqq qciiaaxfno (evqpuuibbh, 19.85)
Phase 3
58
Placebo
(Placebo)
kyayhazaek(qpcejolsgl) = jwkotxozpn gevjkdomwv (zhuclcnuzg, 46.87)
-
21 Mar 2013
(Mipomersen)
kyayhazaek(qpcejolsgl) = whvgqslzvb gevjkdomwv (zhuclcnuzg, 24.71)
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Deal

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Core Patent

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Clinical Trial

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Approval

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Regulation

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