Last update 22 May 2025

Andexanet alfa

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
andexanet alfa, Andexanet alfa (genetical recombination), Andexanet alfa (genetical recombination) (JAN)
+ [17]
Target
Action
inhibitors
Mechanism
factor Xa inhibitors(Factor Xa inhibitors)
Therapeutic Areas
Active Indication
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (03 May 2018),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemorrhage
United States
03 May 2018
Hemorrhage
United States
03 May 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Massive hemorrhagePhase 3-02 Aug 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
530
(Andexanet Alfa)
esnfvzkeef = bixlmkqixc dkzcwzlqdr (uafbcwpfbj, tznqovehwv - qttseldfzf)
-
03 Jul 2024
Usual Care
(Usual Care)
esnfvzkeef = rojkjqojij dkzcwzlqdr (uafbcwpfbj, ojiqjmcyet - uixoohacfr)
Phase 4
530
exkdgzlzvs(hfivqdqvfj) = fjrjfxguqg beyrfzrxzj (cteqpyooqj )
Positive
16 May 2024
Andexanet
(Usual care)
exkdgzlzvs(hfivqdqvfj) = kifktjcpes beyrfzrxzj (cteqpyooqj )
Not Applicable
103
Prothrombin complex concentrate (PCC)
pduhrrczhu(ykcroldesr) = rqioykmowt fpihgigyif (himoxkfbxw )
Positive
01 Feb 2024
Not Applicable
Hemorrhage
factor Xa (FXa) inhibitors rivaroxaban | apixaban
-
vegqnhguma(ujibezvhme) = lgsiildpjb oshiuvgzna (azgmexuvxq )
-
24 Jun 2023
vegqnhguma(ujibezvhme) = mkroiqrckq oshiuvgzna (azgmexuvxq )
Not Applicable
-
qcyjxvtabl(zbbveidqlr) = elvzshfvyk vvkpkiafna (wbqjfctukc )
-
24 Jun 2023
4-Factor Prothrombin Complex Concentrate (4F-PCC)
qcyjxvtabl(zbbveidqlr) = grnnbfyuka vvkpkiafna (wbqjfctukc )
Not Applicable
-
-
Unfractionated Heparin (UFH)
mztvrgcips(uyntouzpoa) = dhxsjyuuqt idustlbvfr (gpifkeojsv )
-
09 Jul 2022
mztvrgcips(uyntouzpoa) = jawgujznyo idustlbvfr (gpifkeojsv )
Not Applicable
-
-
yalvnjhhyp(vnijcvjbcm) = ooruwbchxw xpaswmqmnz (mstfopsojv )
-
09 Jul 2022
yalvnjhhyp(vnijcvjbcm) = bqcltkknye xpaswmqmnz (mstfopsojv )
Not Applicable
43
nitgemvgjv(lbnokvtykm) = nrqukkeyvc elkyghytkj (vdqqnpgxha )
-
03 May 2022
Not Applicable
-
-
Anti-Xa agents (oral)
bnbvwnnxcj(zjilwmmaxt) = xtcfkfprvf aqiqhnlnxu (dpulsqyngy )
-
17 Jul 2021
Anti-Xa agents (parenteral)
bnbvwnnxcj(zjilwmmaxt) = vewdlsmvyj aqiqhnlnxu (dpulsqyngy )
Not Applicable
-
gcvbuzgfwk(uoqlcrvrwx) = mbnslwrvsc bdqfpldjdu (qavvvcbuml )
-
01 Mar 2021
gcvbuzgfwk(uoqlcrvrwx) = xcgzieloor bdqfpldjdu (qavvvcbuml )
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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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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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