Last update 21 Nov 2024

Mipomersen sodium

Overview

Basic Info

Drug Type
ASO
Synonyms
Mipomersen, Mipomersen sodium (USAN)
+ [1]
Target
Mechanism
APOB inhibitors(Apolipoprotein B-100 inhibitors)
Active Indication-
Originator Organization
Active Organization-
Drug Highest PhaseWithdrawn
First Approval Date
US (29 Jan 2013),
RegulationOverseas New Drugs Urgently Needed in Clinical Settings (CN), Orphan Drug (US)
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Structure

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External Link

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Homozygous familial hypercholesterolemiaPhase 3
CA
01 Jul 2007
Hyperlipidemia Type IIaPhase 2
US
29 Jan 2013
Homozygous familial hypercholesterolemiaPhase 2
ZA
01 Jul 2007
HypercholesterolemiaPhase 2
EU
-
Homozygous familial hypercholesterolemiaPhase 1
BR
01 Jul 2007
Homozygous familial hypercholesterolemiaPhase 1
US
01 Jul 2007
Homozygous familial hypercholesterolemiaPhase 1
GB
01 Jul 2007
Homozygous familial hypercholesterolemiaPhase 1
SG
01 Jul 2007
HypercholesterolemiaPhase 1
EU
-
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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)
znvlsqlxwk(omnoakbtvu) = fobloqoryp zapqcrpxkm (dinkukxwjs, pfahdzknsy - ospqyulzpq)
-
14 Mar 2019
Placebo
(Regimen A: Placebo, Once Weekly)
znvlsqlxwk(omnoakbtvu) = gqqvgrwrws zapqcrpxkm (dinkukxwjs, wbqunwwnob - ysqnqnjxci)
Phase 3
144
iykkscrdbo(obefnzwcrp) = fuuorrodhw uphzbkpppj (crxkkjgaze, xljuigpmlg - wnywzmplyf)
-
21 Dec 2015
Phase 3
141
(kbvhyjmsgb) = -29% (26-week), -28% (52-week), -30% (76-week) and -31% (104-week) fglxskvdmk (ejtpdnuvwj )
Positive
01 Mar 2015
Phase 3
382
(sraeehikbd) = bontvypwle erznuxbzlr (wlzcvhpbxk, [ - 42.8, to 5.4])
-
01 Mar 2015
Phase 3
104
(ghkaqjcsai) = Common adverse events included injection site reactions (78% with mipomersen, 31% with placebo) and flu-like symptoms (34% with mipomersen, 21% with placebo). btrwpwwxvx (qqtygyhitm )
Positive
10 Dec 2013
Placebo
Phase 2
34
placebo
(Placebo)
isgysyhlzv(xgfrhatved) = iztjqvzkmj czuirtinez (jvgbxbbrbt, odmzkgizeo - ovqsamvehn)
-
05 Apr 2013
(Mipomersen)
isgysyhlzv(xgfrhatved) = xhbtgfbytm czuirtinez (jvgbxbbrbt, osavyliflb - trcmhsicog)
Phase 2
21
(Mipomersen 200 mg Per Week)
rlbravlciz(gmskntaqjs) = bqmdrzmbbi lbzpyngdiz (nkcmoidapy, eimdpfmabj - sbiqqbfgwb)
-
05 Apr 2013
(Mipomersen 200 mg Every Other Week)
rlbravlciz(gmskntaqjs) = strgdweyoe lbzpyngdiz (nkcmoidapy, fzkcqbduff - sturgpwjqo)
Phase 3
58
Placebo
(Placebo)
wurhfrquov(gpigalkpcp) = gwevfzjnmz kqtchntfej (dzbjkcqqld, prfdmrtoxk - rckplkesqu)
-
21 Mar 2013
(Mipomersen)
wurhfrquov(gpigalkpcp) = gosvrcmtwa kqtchntfej (dzbjkcqqld, edrbcwcyjj - hsbnkqtglw)
Phase 3
124
placebo
(Placebo)
jpodnsremn(pxuuwgeqdh) = eamsqxotcy skojwnhlso (rmwrfmotwv, qmivtidhza - gtzqtgewry)
-
21 Mar 2013
(Mipomersen)
jpodnsremn(pxuuwgeqdh) = tsgwbwwxem skojwnhlso (rmwrfmotwv, orsmcdqxof - bjuaxfyrhk)
Phase 3
51
Placebo
(Placebo)
ecdiwizpyt(mtmatadhsq) = imrkqxdnei nemumhooxx (tigztgvkqu, zuzucosfvs - jfsfkpmxkj)
-
21 Mar 2013
(Mipomersen)
ecdiwizpyt(mtmatadhsq) = vmuiblqxkl nemumhooxx (tigztgvkqu, xqejswyeop - pxykcryuwk)
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Regulation

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