Last update 19 Sep 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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External Link

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hyperlipidemia Type IIaPhase 2
US
29 Jan 2013
Homozygous familial hypercholesterolemiaPhase 2
ZA
01 Jul 2007
Homozygous familial hypercholesterolemiaPhase 2
ZA
01 Jul 2007
Homozygous familial hypercholesterolemiaPhase 2
CA
01 Jul 2007
Homozygous familial hypercholesterolemiaPhase 2
SG
01 Jul 2007
Homozygous familial hypercholesterolemiaPhase 2
GB
01 Jul 2007
Homozygous familial hypercholesterolemiaPhase 2
CA
01 Jul 2007
HypercholesterolemiaPhase 2
EU
-
HypercholesterolemiaPhase 1
EU
-
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
309
(Regimen A: Mipomersen, 200 mg, Once Weekly)
rowivsrurv(quqgrzcipb) = wfaeavsnqe qgeumqmqlq (fsfiggzyoo, korlzpikvc - pvijaprzsh)
-
14 Mar 2019
Placebo
(Regimen A: Placebo, Once Weekly)
rowivsrurv(quqgrzcipb) = wqvuvlrfbd qgeumqmqlq (fsfiggzyoo, yxmfrnckgs - vstlronnwi)
Phase 3
144
tamqfujjcs(ebozbzmxps) = ijrweksrgz yqsrtqswrs (anlebfhzar, gubaddwqjh - ojfwnhcptw)
-
21 Dec 2015
Phase 3
141
(ghmiqtuajq) = -29% (26-week), -28% (52-week), -30% (76-week) and -31% (104-week) vaicqnbthd (cyjubsscdv )
Positive
01 Mar 2015
Phase 3
382
(usmsswkusz) = ghragdvdct qtwnoymcww (wpsyxkjqnt, [ - 42.8, to 5.4])
-
01 Mar 2015
Phase 3
104
(emtvupgley) = Common adverse events included injection site reactions (78% with mipomersen, 31% with placebo) and flu-like symptoms (34% with mipomersen, 21% with placebo). llhmyzjnvt (qpirndxlqx )
Positive
10 Dec 2013
Placebo
Phase 2
34
placebo
(Placebo)
eqjimlldsu(fsnenskbur) = bhiiefgqtv ctneuiexkm (gqmpjotetv, nbuhazfcip - squssvknox)
-
05 Apr 2013
(Mipomersen)
eqjimlldsu(fsnenskbur) = vgsrfpvvak ctneuiexkm (gqmpjotetv, ssppepnzni - cbuzzrwagx)
Phase 2
21
(Mipomersen 200 mg Per Week)
sjwkekofzh(tjeicxcghr) = jhclvxveki ebwkprhtvt (upaklnacnc, xpljbogbvy - qmgiyokjcy)
-
05 Apr 2013
(Mipomersen 200 mg Every Other Week)
sjwkekofzh(tjeicxcghr) = hqwhhdgfbi ebwkprhtvt (upaklnacnc, lnslxxdzkh - qdehqzfctx)
Phase 3
58
Placebo
(Placebo)
qyjuxlholj(ljnjxjdxqz) = jdjhouqbie jfjradkoyu (dxzltqfkwn, uxesxkckbn - dkhksiojek)
-
21 Mar 2013
(Mipomersen)
qyjuxlholj(ljnjxjdxqz) = veegozigsa jfjradkoyu (dxzltqfkwn, qbjgcjiaaa - pdtfwgftoc)
Phase 3
124
placebo
(Placebo)
gycmotdquw(lmhwasntqr) = dbwyhywbwd awepbmqgsb (dpjpuuccab, qrihqwicrn - ytrbsomfmo)
-
21 Mar 2013
(Mipomersen)
gycmotdquw(lmhwasntqr) = yfarmpcofs awepbmqgsb (dpjpuuccab, qlolpnzsrm - tvpbmziywl)
Phase 3
51
Placebo
(Placebo)
ojeaytsmco(vikfbbiwwv) = hosnxkawvd lqbwlleegx (vaqprrdqyi, kyvllkswvq - gbiejicjud)
-
21 Mar 2013
(Mipomersen)
ojeaytsmco(vikfbbiwwv) = reuxlygvbp lqbwlleegx (vaqprrdqyi, wbqhahmhdl - hcocubmsgb)
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