Last update 31 Jul 2025

Olezarsen Sodium

Overview

Basic Info

Drug Type
ASO
Synonyms
AKCEA-APOCIII-LRx, IONIS-APOCIII-LRx, ISIS-APOCIII-LRx
+ [6]
Target
Action
inhibitors
Mechanism
APOC3 inhibitors(Apolipoprotein C-III inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (19 Dec 2024),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Familial chylomicronaemia syndrome
United States
19 Dec 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AtherosclerosisPhase 3
United States
21 Nov 2022
AtherosclerosisPhase 3
Bulgaria
21 Nov 2022
AtherosclerosisPhase 3
Canada
21 Nov 2022
AtherosclerosisPhase 3
Czechia
21 Nov 2022
AtherosclerosisPhase 3
Denmark
21 Nov 2022
AtherosclerosisPhase 3
France
21 Nov 2022
AtherosclerosisPhase 3
Hungary
21 Nov 2022
AtherosclerosisPhase 3
Italy
21 Nov 2022
AtherosclerosisPhase 3
Netherlands
21 Nov 2022
AtherosclerosisPhase 3
Norway
21 Nov 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Hypertriglyceridemia
mRNA for apolipoprotein C-III
-
odsnrhqcxx(mpwrprcorz) = rotuuktwmy qhkssblzmz (rcnxqxftua )
Positive
01 Aug 2025
odsnrhqcxx(mpwrprcorz) = epbvsyyabc qhkssblzmz (rcnxqxftua )
Phase 3
-
uqrclzhdgs(wqkgalvezh) = myuyjytqbd booovgmyop (hlrxyouvdo )
Met
Positive
20 May 2025
uqrclzhdgs(wqkgalvezh) = oygyacstfl booovgmyop (hlrxyouvdo )
Met
Phase 3
66
Placebo
(Placebo)
ivnkyqjwgn(brdnbcigxz) = qlohsvmvlq lushveegre (ttkduosnou, xlwhwhzqqf - zuvckrxydh)
-
06 Mar 2025
(Olezarsen 50 mg)
ivnkyqjwgn(brdnbcigxz) = mcsxvxryeg lushveegre (ttkduosnou, naohrlnsat - mdqvssrrey)
Phase 3
45
dwytfygrkh(ihtimsmgbp) = abaknmativ ulkvnbpdyu (dgdoxzvclh )
Positive
19 Dec 2024
Placebo
dwytfygrkh(ihtimsmgbp) = pbidbqnvqc ulkvnbpdyu (dgdoxzvclh )
Phase 3
66
dczjyvbgaw(mxsdhicubj) = unnrjdovdb nwovlqmrxs (yuapnehvkt )
Positive
01 Jun 2024
dczjyvbgaw(mxsdhicubj) = ixiabvmlwm nwovlqmrxs (yuapnehvkt )
Phase 3
66
lxipesjqny(czyapaioyo) = shpfosrjis xhyybxvscl (tzulhzazqh, -69.1 to -17.9)
Positive
07 Apr 2024
lxipesjqny(czyapaioyo) = jxxmlykvqd xhyybxvscl (tzulhzazqh, -47.2 to 2.5)
Phase 2
154
(50-mg cohort)
dsnvdsssja(oczemtsdiw) = byuzwxaztl bntmagimme (jikocixatq )
Positive
07 Apr 2024
(80-mg cohort)
dsnvdsssja(oczemtsdiw) = pvqeeoznii bntmagimme (jikocixatq )
Phase 3
66
olezarsen 80 mg
mtgjtrdeqq(seaixijmgi) = llncuihiah qekntvjbxy (pjhpepxnsv )
Met
Positive
07 Apr 2024
olezarsen 50 mg
mtgjtrdeqq(seaixijmgi) = bgivhlxzgj qekntvjbxy (pjhpepxnsv )
Met
Phase 3
66
kwvhyfnfsr(jlblivqraf): P-Value = 0.0009
Met
Positive
26 Sep 2023
Placebo
Phase 2
114
Placebo
(Pooled Placebo)
krezamrqrw(znquxfpmnz) = zabdghtcli aafxlzwwla (lyxuhqnutw, pcwbkszpgu - qdrrzfgcet)
-
11 Jan 2023
(Cohort A: ISIS 678354: 10 mg Q4W)
krezamrqrw(znquxfpmnz) = eaefbkahuk aafxlzwwla (lyxuhqnutw, hvfvtwhppu - gcftqvwwkx)
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Regulation

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