Last update 16 May 2024

Patisiran sodium

Overview

Basic Info

Drug Type
Small interfering RNA
Synonyms
Patisiran sodium (JAN), patisiran, patisiran-LNP
+ [6]
Target
Mechanism
TTR inhibitors(Transthyretin inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (JP), Fast Track (US), Breakthrough Therapy (US), Priority Review (US)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Amyloidosis
BR
01 May 2020
Polyneuropathies
LI
27 Aug 2018
Polyneuropathies
IS
27 Aug 2018
Polyneuropathies
NO
27 Aug 2018
Polyneuropathies
EU
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
Amyloidosis, Hereditary, Transthyretin-RelatedPhase 3
PT
16 Jul 2015
Amyloidosis, Hereditary, Transthyretin-RelatedPhase 3
FR
16 Jul 2015
Amyloidosis, Hereditary, Transthyretin-RelatedPhase 3
AR
16 Jul 2015
Amyloidosis, Hereditary, Transthyretin-RelatedPhase 3
BR
16 Jul 2015
AmyloidosisPhase 1
CY
01 Nov 2013
AmyloidosisPreclinical
MY
01 Nov 2013
AmyloidosisDiscovery
TR
01 Nov 2013
AmyloidosisDiscovery
CA
01 Nov 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
359
wybbswkvat(ppyusopypi) = Patisiran demonstrated a benefit or trend toward benefit in change from baseline of most echocardiographic parameters compared with placebo at Month 12 vywztofdjb (ekedvnwjgf )
Positive
30 Sep 2022
Placebo
Phase 2
29
(swzfkhfxid) = 4 SAEs were reported in 1 patient administered 0.3 mg/kg Q3W (urinary tract infection, sepsis, nausea, vomiting), and 1 patient administered 0.3 mg/kg Q4W had 1 SAE (extravasation-related cellulitis) fwkisgmdui (xepbqeypoc )
Positive
04 Sep 2015
Phase 3
Amyloidosis
transthyretin (TTR) amyloid | N-terminal prohormone B-type natriuretic peptide | troponin I ...
360
efkkagzryv(emlhczpzbb): OR = 1.58 (95% CI, 1.03 - 2.42)
-
26 Aug 2023
Placebo
Phase 2
27
(bxxwyxhzlm) = mild/moderate in severity hvmlqjbozu (zqnnrelxns )
Positive
08 Jul 2020
Phase 3
18
(wsfbywqaud) = pdoeprusot tvynbersfv (uqdyagqxfe )
Positive
27 Mar 2024
Phase 3
23
rixcxdfzyn(qeupwtslgb) = fbcchzgmke wyokshhieg (lxaawwfbth, 86.1 - 92.3)
Positive
25 Feb 2022
Phase 3
360
Patisiran 0.3 mg/kg
mafgjcyeip(bedkqjzjuz) = mwbdjbecmb prumdwlssh (fhzqzsummn, 0.69-28.69; P=0.02)
Met
Positive
25 Oct 2023
Phase 3
225
(qokxzrwjxu) = The mean (±SD) mNIS+7 at baseline was 80.9±41.5 in the patisiran group and 74.6±37.0 in the placebo group; the least-squares mean (±SE) change from baseline was -6.0±1.7 versus 28.0±2.6 phizamijhd (axutalnyri )
Positive
05 Jul 2018
Placebo
Phase 3
360
(mwmenzayuu) = zmscnwktlj ibnuuamvzi (fttccjbbiz )
Positive
08 Sep 2022
Placebo
(mwmenzayuu) = yayjerkzyh ibnuuamvzi (fttccjbbiz )
Not Applicable
-
ripupxktsm(exzkeyppql) = tijbbwueol vluryakqdf (jnmvccwkxa )
-
25 Aug 2023
kgxfltsmsc(gonlrwwnrx) = knamnpcgyx tthlunhzvv (jvjnwghesw )
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