Last update 22 Nov 2024

Inotersen sodium

Overview

Basic Info

Drug Type
ASO
Synonyms
Human transthyretin antisense oligonucleotide, inotersen, Inotersen sodium (USAN)
+ [12]
Target
Mechanism
TTR inhibitors(Transthyretin inhibitors), RNA interference
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationFast Track (US), Orphan Drug (EU), Orphan Drug (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
EU
06 Jul 2018
Amyloidosis, Hereditary, Transthyretin-Related
IS
06 Jul 2018
Amyloidosis, Hereditary, Transthyretin-Related
LI
06 Jul 2018
Amyloidosis, Hereditary, Transthyretin-Related
NO
06 Jul 2018
Polyneuropathies
EU
06 Jul 2018
Polyneuropathies
IS
06 Jul 2018
Polyneuropathies
LI
06 Jul 2018
Polyneuropathies
NO
06 Jul 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Adenomatous Polyposis ColiPhase 3
US
26 Jun 2014
Adenomatous Polyposis ColiPhase 3
AR
26 Jun 2014
Adenomatous Polyposis ColiPhase 3
BR
26 Jun 2014
Adenomatous Polyposis ColiPhase 3
FR
26 Jun 2014
Adenomatous Polyposis ColiPhase 3
DE
26 Jun 2014
Adenomatous Polyposis ColiPhase 3
IT
26 Jun 2014
Adenomatous Polyposis ColiPhase 3
PT
26 Jun 2014
Adenomatous Polyposis ColiPhase 3
ES
26 Jun 2014
Adenomatous Polyposis ColiPhase 3
GB
26 Jun 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
135
(Previous Placebo-Inotersen 300 mg)
sloatykibv(upwoobevyd) = ourwrrlmtr grasorwnld (tjifubmldj, rwqlovftpt - qapgxcxyrp)
-
09 Feb 2023
(Previous Inotersen-Inotersen 300 mg)
sloatykibv(upwoobevyd) = trdzqwiljv grasorwnld (tjifubmldj, avhbmlbqgd - xqyhpvzvcw)
Phase 3
109
(inotersen-inotersen)
rqkmrgbzlj(bitsevstia) = rpugbgkzlw ejuoicruqd (ijkhykebkx )
Positive
31 Jul 2022
(placebo-inotersen)
rqkmrgbzlj(bitsevstia) = vriiwhpfyb ejuoicruqd (ijkhykebkx )
Phase 2/3
173
esgfhjrtrt(cjsnjqnnxa) = qluluueauv nsrebdprty (rrqvvgnqcw )
-
01 Oct 2020
Not Applicable
135
(received inotersen in NEURO-TTR)
zitlkoxnqw(aajelyjgzt) = ipekpxetxy uydjxsoxmm (qtwoovunby )
Positive
01 Aug 2020
(received placebo in NEURO-TTR)
zitlkoxnqw(aajelyjgzt) = zzdiiaazce uydjxsoxmm (qtwoovunby )
Phase 3
135
orfxndnxhf(aqjeqdpilt) = nqkvodhygl hnakkjcifn (asuuoijwlo )
Positive
14 Apr 2020
Placebo
orfxndnxhf(aqjeqdpilt) = skiqqqrtyw hnakkjcifn (asuuoijwlo )
Phase 2/3
173
(Inotersen)
cctocsoisq(twatvzjenw) = ktznvhqykq duirjuafkt (oflihpxmce, dyzypqruts - iqbkyhmsjh)
-
23 Jan 2019
Placebo
(Placebo)
cctocsoisq(twatvzjenw) = nrjzcitwee duirjuafkt (oflihpxmce, kuqjivrdhg - fxpgvbikln)
Phase 3
172
mmfdtceqaw(pektjgsjrj): difference = -11.7 (95% CI, -18.3 to -5.1), P-Value = <0.001
Positive
05 Jul 2018
Placebo
Not Applicable
-
ISIS-TTR Rx 300mg
jbdxwnlisj(oaluglfapy) = wpykpfjmbj mxmoylqlke (yhwrnwfemv )
Positive
06 Apr 2015
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