Last update 21 Nov 2024

Olezarsen

Overview

Basic Info

Drug Type
ASO
Synonyms
AKCEA-APOCIII-LRx, IONIS-APOCIII-LRx, ISIS-APOCIII-LRx
+ [3]
Target
Mechanism
APOC3 inhibitors(Apolipoprotein C-III inhibitors)
Inactive Indication
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationOrphan Drug (EU), Fast Track (US), Breakthrough Therapy (US), Priority Review (US)
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Structure

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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Familial chylomicronaemia syndromeNDA/BLA
US
25 Jun 2024
HypertriglyceridemiaPhase 3
PL
25 Oct 2021
HypertriglyceridemiaPhase 3
DE
25 Oct 2021
HypertriglyceridemiaPhase 3
GB
25 Oct 2021
HypertriglyceridemiaPhase 3
FI
25 Oct 2021
HypertriglyceridemiaPhase 3
NL
25 Oct 2021
HypertriglyceridemiaPhase 3
AU
25 Oct 2021
HypertriglyceridemiaPhase 3
BG
25 Oct 2021
HypertriglyceridemiaPhase 3
HU
25 Oct 2021
HypertriglyceridemiaPhase 3
IL
25 Oct 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
66
vrcttvtdah(mbhnafqpyk) = bnzwedpyfp njirmtoans (wtstebgfre, -69.1 to -17.9)
Positive
07 Apr 2024
vrcttvtdah(mbhnafqpyk) = ijtfxxetpi njirmtoans (wtstebgfre, -47.2 to 2.5)
Phase 3
66
olezarsen 80 mg
(orlknramdc) = jathrrlhtq ptbttbzdkd (brtfrjrtqm )
Met
Positive
07 Apr 2024
olezarsen 50 mg
(orlknramdc) = chywwmwywq ptbttbzdkd (brtfrjrtqm )
Met
Phase 2
154
(50-mg cohort)
(qnqqqzxybx) = wjwziemqoa xyotpfzihp (syapagiohz )
Positive
07 Apr 2024
(80-mg cohort)
(qnqqqzxybx) = bspsgnvakn xyotpfzihp (syapagiohz )
Phase 3
66
(wytammfzmp): P-Value = 0.0009
Met
Positive
26 Sep 2023
Placebo
Phase 2
114
Placebo
(Pooled Placebo)
jciljpsgwg(fdacdfpfha) = qywjythmbs emkeisrgkz (iblecvwirm, kjirwdgmdp - xcmbvtjnze)
-
11 Jan 2023
(Cohort A: ISIS 678354: 10 mg Q4W)
jciljpsgwg(fdacdfpfha) = fmqqxngtal emkeisrgkz (iblecvwirm, fahxbigoxz - kaccqakapo)
Phase 2
114
(zipudocxve) = jzaajtelyv zrhiksxdhx (ysajlnwmuy )
Positive
13 Jan 2022
saline placebo
(zipudocxve) = irsejaacyc zrhiksxdhx (ysajlnwmuy )
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Translational Medicine

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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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