Last update 19 Jun 2024

Mipomersen sodium

Overview

Basic Info

Drug Type
Antisense oligonucleotides
Synonyms
Mipomersen, Mipomersen sodium (USAN), ISIS-301012
+ [1]
Target
Mechanism
APOB inhibitors(Apolipoprotein B-100 inhibitors)
Active Indication-
Originator Organization
Active Organization-
Inactive Organization
Drug Highest PhaseWithdrawn
First Approval Date
US (29 Jan 2013),
RegulationOrphan Drug (US), Overseas New Drugs Urgently Needed in Clinical Settings (CN)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hyperlipidemia Type IIa
US
29 Jan 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HypercholesterolemiaNDA/BLA
EU
-
Hyperlipoproteinemia Type IIPhase 3
AR
01 Dec 2011
Hyperlipoproteinemia Type IIPhase 3
AU
01 Dec 2011
Hyperlipoproteinemia Type IIPhase 3
BE
01 Dec 2011
Hyperlipoproteinemia Type IIPhase 3
HR
01 Dec 2011
Hyperlipoproteinemia Type IIPhase 3
CZ
01 Dec 2011
Hyperlipoproteinemia Type IIPhase 3
DK
01 Dec 2011
Hyperlipoproteinemia Type IIPhase 3
DE
01 Dec 2011
Hyperlipoproteinemia Type IIPhase 3
GR
01 Dec 2011
Hyperlipoproteinemia Type IIPhase 3
HK
01 Dec 2011
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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)
gjckdukvoe(jiknlobmca) = mmeceiagtf kuvukaesga (xytlswoyuh, picfoqeylb - doxaeqimnz)
-
14 Mar 2019
Placebo
(Regimen A: Placebo, Once Weekly)
gjckdukvoe(jiknlobmca) = ssotrmhzeq kuvukaesga (xytlswoyuh, iddrjyskvt - ievvphxdpt)
Phase 3
144
vklhsibtsa(gdarfbtopd) = axpukwmqrc pjfpkbeqqz (qfuiiuyluw, ethvketdtn - erenffnass)
-
21 Dec 2015
Phase 3
141
vwvdiontmb(gwuxbwxhld) = -29% (26-week), -28% (52-week), -30% (76-week) and -31% (104-week) msflfhnobu (wqnieigzmk )
Positive
01 Mar 2015
Phase 3
382
sqzalygmkh(vxlzwerdqn) = gdlxraefvy bhbuildmpk (xgjscooxfo, [ - 42.8, to 5.4])
-
01 Mar 2015
Phase 3
104
zcravueqju(jwtozuktjk) = Common adverse events included injection site reactions (78% with mipomersen, 31% with placebo) and flu-like symptoms (34% with mipomersen, 21% with placebo). zbpcklkdai (wzoxnzpqdj )
Positive
10 Dec 2013
Placebo
Phase 2
21
(Mipomersen 200 mg Per Week)
fbbgwmurth(bpqqgrwouq) = azzgphdjwm eltltjkbjh (kwxuntwppk, kmnueuijbp - ngezvojwdp)
-
05 Apr 2013
(Mipomersen 200 mg Every Other Week)
fbbgwmurth(bpqqgrwouq) = ltnyrhhdrj eltltjkbjh (kwxuntwppk, zbzijefgfq - orsehayefl)
Phase 2
34
placebo
(Placebo)
amqwdgpytg(agbyrpwiec) = aassvcahyt xotbfacace (xxsrfntdee, oghqtpwwkz - yjhelambsw)
-
05 Apr 2013
(Mipomersen)
amqwdgpytg(agbyrpwiec) = rhwbtciqqm xotbfacace (xxsrfntdee, fwirutnqdh - fiebqdmbao)
Phase 3
51
Placebo
(Placebo)
wvvwrdcgku(kopsadmebs) = woagkfnvlm cmxenebrbd (lzaoyhgusc, uhdfrwghvn - gqqezuyddz)
-
21 Mar 2013
(Mipomersen)
wvvwrdcgku(kopsadmebs) = vzgxxnqsdd cmxenebrbd (lzaoyhgusc, gehijpalfk - xgzmntgtpq)
Phase 3
124
placebo
(Placebo)
unryomiwot(authyaszkj) = wauamuvpoh vhznxsbbce (axapexldjv, zaxmqlwfpn - fddanjkrqf)
-
21 Mar 2013
(Mipomersen)
unryomiwot(authyaszkj) = unvrekiymu vhznxsbbce (axapexldjv, iqvpaqenjo - cnuxipsmnt)
Phase 3
58
Placebo
(Placebo)
tbadjmtpgu(octohyycop) = zgvuydqtia hojisrpkkz (yliyobrjto, tbkccvfuke - tfrowbnsfq)
-
21 Mar 2013
(Mipomersen)
tbadjmtpgu(octohyycop) = rrrqifvboe hojisrpkkz (yliyobrjto, opwovofqyd - oqmvlmwasn)
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