Last update 08 May 2025

Fitusiran

Overview

Basic Info

Drug Type
siRNA
Synonyms
Fitusiran Sodium, 费妥赛仑
+ [5]
Target
Action
inhibitors
Mechanism
AT III inhibitors(Antithrombin-III inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (28 Mar 2025),
RegulationFast Track (United States), Orphan Drug (United States), Priority Review (China)
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Structure/Sequence

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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia A
United States
28 Mar 2025
Hemophilia B
United States
28 Mar 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hemophilia ANDA/BLA
United States
-
Hemophilia ANDA/BLA
China
-
Hemophilia BNDA/BLA
United States
-
HemorrhagePhase 3
Spain
01 Feb 2023
HemorrhagePhase 3
Italy
01 Feb 2023
HemorrhagePhase 3
United States
01 Feb 2023
HemorrhagePhase 3
Saudi Arabia
01 Feb 2023
HemorrhagePhase 3
India
01 Feb 2023
HemorrhagePhase 3
Turkey
01 Feb 2023
HemorrhagePhase 3
Canada
01 Feb 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
QFITLIA AT-DR
(prior bypassing agent)
(xcnqbdtoza) = qrfguxssva vkmavecebw (fwlqtktalu, 2.8 - 9.5)
Positive
28 Mar 2025
On-Demand BPA
(prior bypassing agent)
(xcnqbdtoza) = olcxdvxhyt vkmavecebw (fwlqtktalu, 11.8 - 31.0)
Phase 2
34
(AT-based dose regimen)
(ktszqepbjb) = zkyrnaiydf rvskmbmhwg (vavusvljrx )
Positive
06 Dec 2024
(the original dose regimen)
(ktszqepbjb) = maoklnvhxa rvskmbmhwg (vavusvljrx )
Phase 1/2
34
(Original Dose Regimen (SAS 1))
ypefioxmfg(nkclcwcacl) = jjtwakyole filuccqfvr (lhxuwynzxn, ltzgeekuex - ayvptuzuzk)
-
05 Jun 2024
(AT-Based Dose Regimen (SAS 2))
ypefioxmfg(nkclcwcacl) = sikoedyumd filuccqfvr (lhxuwynzxn, ainmtcrmny - sipwamgkfi)
Phase 3
57
(yastfaaloh) = gcmhecgjtg wysmwyljyt (jmeqpomnmz, 1.0 - 2.7)
Positive
29 Apr 2023
bypassing agents
(yastfaaloh) = kfwwsggmom wysmwyljyt (jmeqpomnmz, 10.6 - 30.8)
Phase 3
80
(rtsfktjkou) = thffclkbqw qcgicqblqa (lgvmbarntm )
Positive
10 Jul 2022
Phase 3
217
xbwlkkcmsp(ojnphrplmo) = bpooalkjob aqsvctkqti (vjfuuadnnv )
-
09 Jul 2022
Phase 3
-
bygjqkpwgu(fouxbdoucy) = qtnnuevpzi iwriuatenk (fdohkkwjcp )
-
09 Jul 2022
Phase 3
Hemophilia
inhibitors
118
letpxbbdsv(wdgexvwkqr) = wgaffzeetj ujpplsqees (lqluxlhmwr )
-
09 Jul 2022
Phase 3
116
once-monthly 80 mg SC fitusiran prophylaxis
(ifebkwmpgr) = fhkudnxejw bwbksqxwjh (mancbozdxy, 84.1 - 93.6)
Positive
04 Dec 2021
on-demand (OD) treatment with factor concentrates
(hfmgjrqczt) = uhedfaopta anouxqtrif (ctyluiexmu, 8.4 - 41.0)
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Translational Medicine

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Deal

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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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