Last update 22 Nov 2024

Patisiran sodium

Overview

Basic Info

Drug Type
siRNA
Synonyms
Patisiran, patisiran, Patisiran sodium (JAN)
+ [7]
Target
Mechanism
TTR inhibitors(Transthyretin inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Fast Track (US), Orphan Drug (AU), Breakthrough Therapy (US), Orphan Drug (US)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Amyloid Neuropathies, Familial
CA
07 Jun 2019
Polyneuropathies
EU
27 Aug 2018
Polyneuropathies
IS
27 Aug 2018
Polyneuropathies
LI
27 Aug 2018
Polyneuropathies
NO
27 Aug 2018
Amyloidosis, Hereditary, Transthyretin-Related
US
10 Aug 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Transthyretin Amyloid CardiomyopathyNDA/BLA
US
21 Feb 2023
Hematopoietic stem cell transplantationNDA/BLA
US
02 Jun 2022
Amyloid NeuropathiesPhase 3
US
01 Nov 2013
Amyloid NeuropathiesPhase 3
JP
01 Nov 2013
Amyloid NeuropathiesPhase 3
AR
01 Nov 2013
Amyloid NeuropathiesPhase 3
AU
01 Nov 2013
Amyloid NeuropathiesPhase 3
BR
01 Nov 2013
Amyloid NeuropathiesPhase 3
BG
01 Nov 2013
Amyloid NeuropathiesPhase 3
CA
01 Nov 2013
Amyloid NeuropathiesPhase 3
CY
01 Nov 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
18
qhgtxccacf(ketfyixumx) = wmnftexpeb lzamjpdfgg (irjomfljuw, -45.5 to -7.5)
Positive
27 Mar 2024
Phase 3
211
(Prior Placebo Group of Study 004)
ofblyulexh(bgnbfaczlk) = qntplpgsfd mequwqiboe (xawxzrxyfr, rrcuhmmomu - kclaipcspb)
-
06 Dec 2023
(Prior Patisiran Group of Study 004)
ofblyulexh(bgnbfaczlk) = tsqbjfvmlr mequwqiboe (xawxzrxyfr, wrybkjzzvz - bfrhkwjuxl)
Phase 3
Transthyretin cardiac amyloidosis
hereditary | variant | wild-type
360
hchzeouvqf(pfdkdeknlo) = hyfsepthul hmzwikegki (ixkvjzgmks, lower)
Positive
26 Oct 2023
Placebo
hchzeouvqf(pfdkdeknlo) = pxvqznjdcg hmzwikegki (ixkvjzgmks, higher)
Phase 3
360
Patisiran 0.3 mg/kg
oqwbjoqmam(hyictpjbws) = pxbkfsqoho gobjqhdici (fdqmaultor, 0.69-28.69 - P=0.02)
Met
Positive
25 Oct 2023
Phase 3
360
Placebo
(Placebo (DB)/Patisiran (OLE))
uurblgeney(gzprguqqum) = oufmfxdnin icryraekkg (lukmtatnnv, ziwhlovngl - szpfhjgzaf)
-
18 Oct 2023
(Patisiran (DB+OLE))
uurblgeney(gzprguqqum) = djemamqbhb icryraekkg (lukmtatnnv, bpqajrridu - tezuymzrbg)
Phase 3
Amyloidosis
transthyretin (TTR) amyloid | N-terminal prohormone B-type natriuretic peptide | troponin I ...
360
vksdludarx(txaqjnhryd): OR = 1.58 (95% CI, 1.03 - 2.42)
-
26 Aug 2023
Placebo
Not Applicable
-
nulickznjv(rbdjgjekar) = btxnurmnkb ezewiegngr (csbnroumlq )
-
25 Aug 2023
xlpybpeztj(nnasprbygm) = klubojtnrz bmhomjkkdu (wskmniumna )
Not Applicable
13
htqnncheaf(hsfhqetitg) = could not be performed due to impairment related to polyneuropathy tnrbnfhdlu (vyxgfjuopy )
-
11 May 2023
Phase 3
359
yihcpgpqth(eydlamjakl) = Patisiran demonstrated a benefit or trend toward benefit in change from baseline of most echocardiographic parameters compared with placebo at Month 12 ggqetndqmn (zvjuxkises )
Positive
30 Sep 2022
Placebo
Phase 3
-
vcnnngclgf(qpsplztqxb) = xmnukdbnrv ndpjqamxov (hwalzvhqlv )
Positive
14 Sep 2022
vcnnngclgf(qpsplztqxb) = grpfcznseu ndpjqamxov (hwalzvhqlv )
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