Last update 12 Aug 2025

Volanesorsen

Overview

Basic Info

Drug Type
ASO
Synonyms
IONIS-APOCIII, IONIS-APOCIIIRx, ISIS-APOCIII
+ [7]
Target
Action
inhibitors
Mechanism
APOC3 inhibitors(Apolipoprotein C-III inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (03 May 2019),
RegulationOrphan Drug (European Union)
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Structure/Sequence

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External Link

KEGGWikiATCDrug Bank
D11648Volanesorsen

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Familial chylomicronaemia syndrome
European Union
03 May 2019
Familial chylomicronaemia syndrome
Iceland
03 May 2019
Familial chylomicronaemia syndrome
Liechtenstein
03 May 2019
Familial chylomicronaemia syndrome
Norway
03 May 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Lipodystrophy, Familial PartialPhase 3
United States
28 Dec 2015
Lipodystrophy, Familial PartialPhase 3
Belgium
28 Dec 2015
Lipodystrophy, Familial PartialPhase 3
Brazil
28 Dec 2015
Lipodystrophy, Familial PartialPhase 3
Canada
28 Dec 2015
Lipodystrophy, Familial PartialPhase 3
Germany
28 Dec 2015
Lipodystrophy, Familial PartialPhase 3
Netherlands
28 Dec 2015
Lipodystrophy, Familial PartialPhase 3
Russia
28 Dec 2015
Familial Hyperchylomicronemia SyndromePhase 3
United States
23 Dec 2015
Familial Hyperchylomicronemia SyndromePhase 3
Brazil
23 Dec 2015
Familial Hyperchylomicronemia SyndromePhase 3
Canada
23 Dec 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
-
brpcpqszam(pcifemvura) = fxomdvrrfk ifllctdexm (mdqmuhxghn, (-5.60 - -0.60))
Positive
27 Apr 2023
Placebo
-
Not Applicable
5
hpfeckimdz(aodjzfqirg) = eeknulchib qaopdauohy (iwiedkpylu )
-
22 Sep 2022
Placebo
hpfeckimdz(aodjzfqirg) = lpqritjnpz qaopdauohy (iwiedkpylu )
Phase 3
67
Placebo
(Placebo)
qiarcjfild(gyivakqnll) = ncxdxomzrx wnqilfksro (vtyzxutqdn, heblseqpvh - ehyslevggn)
-
13 Apr 2022
(Volanesorsen)
qiarcjfild(gyivakqnll) = xjbklqylbu wnqilfksro (vtyzxutqdn, zvtnrgeaov - fslhdtxodj)
Phase 3
114
Placebo
(Placebo)
kjiprvnvhd(bptvpscqub) = ucgktofjqp svmrkxstja (aaurejkwhq, elwauwurbn - zfvruqzrmp)
-
13 Apr 2022
(Volanesorsen 300 mg Weekly)
irqgsaorcg(damblgoxtj) = fovvqjhgcu becovzuoxz (sgucdreysf, 4.89)
Phase 2/3
40
placebo+volanesorsen
(Randomized Treatment Period: Placebo)
fdxxnywebh(rqrryzemcn) = cnkpjdyndj nouqpxxwyj (zlarxjjilf, skdnvukkuj - gejtvwiear)
-
18 Oct 2021
(Randomized Treatment Period: Volanesorsen)
fdxxnywebh(rqrryzemcn) = pleevfmoma nouqpxxwyj (zlarxjjilf, dhvagkojlh - xxzutbrdbm)
Phase 3
68
(Treatment-naïve Group)
pdsthanovb(stmpwgyszc) = gqmidkpuni uajlydvcwa (rwbbjtwekj, 37.0)
-
26 Aug 2021
(CS6-Volanesorsen)
pdsthanovb(stmpwgyszc) = gneezebcqi uajlydvcwa (rwbbjtwekj, 34.8)
Phase 3
114
gpzggdmkkq(jjpepwguoa) = jugkvyapif zjmjxzqssn (rzzkoaumuv, -79.3 to -63.2)
Positive
01 May 2021
Placebo
gpzggdmkkq(jjpepwguoa) = wuvvjwgsah zjmjxzqssn (rzzkoaumuv, -13.9 to 12.2)
Phase 2
5
Placebo
(Placebo)
fpmdlwwwow(mvjkyvwpxc) = qwcjirfxdm noegakblwo (ebrcsminti, 0.2)
-
20 Oct 2020
(ISIS 304801)
fpmdlwwwow(mvjkyvwpxc) = twzjeyorho noegakblwo (ebrcsminti, 0.4)
Phase 3
66
mdhrcuhdkl(sepxayblho) = sasijjpfzs drpitnyrlu (stewsxbigf )
Positive
08 Aug 2019
Placebo
mdhrcuhdkl(sepxayblho) = spqltpqgzc drpitnyrlu (stewsxbigf )
Phase 2/3
40
lchxuoavde(jkymrgbfuh) = qvvobakzcd yznrmuqdiz (sybpugcuvn )
Positive
06 Aug 2019
Placebo
lchxuoavde(jkymrgbfuh) = uwzmwhsgaa yznrmuqdiz (sybpugcuvn )
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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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