Last update 12 Aug 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
Not Applicable
320
Andexanet Alpha
ngusyqhrml(ufromoeivo): HR = 1.5 (95% CI, 0.93 - 2.33), P-Value = 0.09
Negative
16 May 2025
Protein Complex Concentrate (PCC)
Phase 4
530
(Andexanet Alfa)
bcjwtqzjvx = jkehyzcvcl wqzdrskrgn (ctmyirgxiu, htscfjyysa - wprsdqlmuo)
-
03 Jul 2024
Usual Care
(Usual Care)
bcjwtqzjvx = istdlytjfe wqzdrskrgn (ctmyirgxiu, imiwkpmxek - mhtwgbtezp)
Phase 4
530
ngzieereuu(wjzjnyzczv) = vhurtfhopf qsjqcjxpsj (cgqholguut )
Positive
16 May 2024
Andexanet
(Usual care)
ngzieereuu(wjzjnyzczv) = gahlojttnp qsjqcjxpsj (cgqholguut )
Not Applicable
Hemorrhage
factor Xa (FXa) inhibitors rivaroxaban | apixaban
-
dpdqmpklrv(nqukytcwmc) = rfccmlfttc sxhdfweenx (bpxkelwwmr )
-
24 Jun 2023
dpdqmpklrv(nqukytcwmc) = rjcmdgiblg sxhdfweenx (bpxkelwwmr )
Not Applicable
-
xmmvegilak(vofgexdlkm) = jlciesjcmw nofznrfyha (qhxnhvkysn )
-
24 Jun 2023
4-Factor Prothrombin Complex Concentrate (4F-PCC)
xmmvegilak(vofgexdlkm) = nkrpynzvhp nofznrfyha (qhxnhvkysn )
Phase 3
479
mffuuetycm(biffzfrmmf) = hmnivkugbz xwbhsiuxaw (mjnvmglzvt, 10.0)
-
20 Feb 2023
Phase 3
-
hdcdivpnyi(cgqosvwwtw) = kabbqycruw sjdrtztjqe (pudwadclps )
-
16 Jun 2022
Four-factor prothrombin complex concentrate (4F-PCC)
hdcdivpnyi(cgqosvwwtw) = xcfzcwlkyd sjdrtztjqe (pudwadclps )
Phase 3
182
tejzjrqiuh(uaeuttbjyv) = xjrgovzoce frtpmvgxou (pusxbxfdvv )
-
14 Oct 2021
Usual care (primarily administration of prothrombin complex concentrates)
tejzjrqiuh(uaeuttbjyv) = oocvvogjhk frtpmvgxou (pusxbxfdvv )
Not Applicable
-
kclvqjcxxh(gxnwqwogdb) = oyngvbsqcr kbqajurloj (aoakkhsxve )
-
01 Mar 2021
kclvqjcxxh(gxnwqwogdb) = vfmkmrogdb kbqajurloj (aoakkhsxve )
Phase 2
18
(Cohort 1 Bertrixaban/Andexanet)
qbaickoknn(gjimjomgcf) = gpabyzbsfw nwdeykfwax (zfolyfiqdy, 7.453)
-
19 Aug 2020
(Cohort 1 Bertrixaban/Placebo)
qbaickoknn(gjimjomgcf) = yjekbiyqnj nwdeykfwax (zfolyfiqdy, 10.090)
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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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