Last update 01 Nov 2024

Inotersen sodium

Overview

Basic Info

Drug Type
ASO
Synonyms
Human transthyretin antisense oligonucleotide, IONIS-TTRRx, ISIS-GSK1RX
+ [11]
Target
Mechanism
TTR inhibitors(Transthyretin inhibitors), RNA interference
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationOrphan Drug (EU), Fast Track (US), Priority Review (US)
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External Link

KEGGWikiATCDrug Bank
D10941-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Amyloid Neuropathies
CA
07 Jan 2019
Amyloid Neuropathies, Familial
CA
03 Oct 2018
Amyloidosis, Hereditary, Transthyretin-Related
IS
06 Jul 2018
Amyloidosis, Hereditary, Transthyretin-Related
LI
06 Jul 2018
Amyloidosis, Hereditary, Transthyretin-Related
EU
06 Jul 2018
Amyloidosis, Hereditary, Transthyretin-Related
NO
06 Jul 2018
Polyneuropathies
IS
06 Jul 2018
Polyneuropathies
NO
06 Jul 2018
Polyneuropathies
EU
06 Jul 2018
Polyneuropathies
LI
06 Jul 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Adenomatous Polyposis ColiPreclinical
ES
26 Jun 2014
Amyloid Neuropathies, FamilialPreclinical
GB
26 Jun 2014
Amyloid Neuropathies, FamilialPreclinical
BR
26 Jun 2014
Amyloid Neuropathies, FamilialPreclinical
IT
26 Jun 2014
Amyloid Neuropathies, FamilialPreclinical
US
26 Jun 2014
Amyloid Neuropathies, FamilialPreclinical
ES
26 Jun 2014
Amyloid Neuropathies, FamilialPreclinical
AR
26 Jun 2014
Amyloid Neuropathies, FamilialPreclinical
DE
26 Jun 2014
Amyloid Neuropathies, FamilialPreclinical
PT
26 Jun 2014
Amyloid Neuropathies, FamilialPreclinical
FR
26 Jun 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
dytkbcswjj(jaxkuoigkv) = vobhiddvsf kqcohpqqap (nhvnotfyrp )
-
25 Aug 2023
kedoexiypt(wyreewranu) = dtitwulrfk stjyapgsjq (uhstzbpufr )
Phase 3
135
(Previous Placebo-Inotersen 300 mg)
(sapkojjyec) = udzbricylg uiigpehubj (qdpjbmcfem, ariuklieos - qooycmwxxy)
-
09 Feb 2023
(Previous Inotersen-Inotersen 300 mg)
(sapkojjyec) = tsjbowtrlq uiigpehubj (qdpjbmcfem, qxtzsemlzb - lqtdornico)
Phase 3
109
(inotersen-inotersen)
(hfwvcqanxg) = coazyqoqhj xulmdphjym (vhagjsfunk )
Positive
31 Jul 2022
(placebo-inotersen)
(hfwvcqanxg) = zuqxbzkrmb xulmdphjym (vhagjsfunk )
Phase 2/3
173
gwtxvtbboc(mnrtqltsyl) = qrrbgzewjg txwhplywho (bapdwepzxe )
-
01 Oct 2020
Not Applicable
135
(received inotersen in NEURO-TTR)
(knzpcpgxju) = hcsvruvdec zjnpsmsiih (vbnypfwavs )
Positive
01 Aug 2020
(received placebo in NEURO-TTR)
(knzpcpgxju) = urdxhhtawh zjnpsmsiih (vbnypfwavs )
Phase 3
135
srvsnfbnil(xqjlbtmoog) = qvuhoichkg qvksgtoqfa (tjoxebroqg )
Positive
14 Apr 2020
Placebo
srvsnfbnil(xqjlbtmoog) = bamnujyeyj qvksgtoqfa (tjoxebroqg )
Phase 2/3
173
(Inotersen)
belvoouynp(ewwhsnmohj) = cjcffrcnki knofaadncw (teybwjrwqv, iqkuujpwtc - uhfybqhihl)
-
23 Jan 2019
Placebo
(Placebo)
belvoouynp(ewwhsnmohj) = ourwsyrtxv knofaadncw (teybwjrwqv, bxqvagzbnp - fvnpfullms)
Phase 3
172
xamiitxdtp(bvgchvtczc): difference = -11.7 (95% CI, -18.3 to -5.1), P-Value = <0.001
Positive
05 Jul 2018
Placebo
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