Last update 08 May 2025

Andexanet alfa

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
Andexanet alfa (USAN/INN), 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), Orphan Drug (United States), Accelerated Approval (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
HemorrhageNDA/BLA
China
16 Dec 2023
HemorrhageNDA/BLA
China
16 Dec 2023
HemorrhageNDA/BLA
China
16 Dec 2023
Massive hemorrhagePhase 2
Japan
02 Aug 2024
Massive hemorrhagePhase 2
Australia
02 Aug 2024
Massive hemorrhagePhase 2
New Zealand
02 Aug 2024
Massive hemorrhagePhase 2
Spain
02 Aug 2024
Massive hemorrhagePhase 2
Slovenia
02 Aug 2024
Massive hemorrhagePhase 2
Slovakia
02 Aug 2024
Massive hemorrhagePhase 2
United Kingdom
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)
huecszbsdd(jdgkqqzimr) = nucjsohafz wnwygieerp (rriavivhue, ajbpxxknjr - nqezmsvetl)
-
03 Jul 2024
Usual care
(Usual Care)
huecszbsdd(jdgkqqzimr) = npqkfawomr wnwygieerp (rriavivhue, sxcrwwdjkc - dcqiaqdjoc)
Phase 4
530
(qfxohgchcq) = wrvkntnbbh ehvamcccov (djqetzgcep )
Positive
16 May 2024
Andexanet
(Usual care)
(qfxohgchcq) = qhvlrrmttm ehvamcccov (djqetzgcep )
Not Applicable
Hemorrhage
factor Xa (FXa) inhibitors rivaroxaban | apixaban
-
ipkmrlduxx(kmqxneglet) = vvotlvkrsy lynxbderuz (tozwqnwlqu )
-
24 Jun 2023
ipkmrlduxx(kmqxneglet) = wjimdbrwsm lynxbderuz (tozwqnwlqu )
Not Applicable
-
(lmefzmtwwn) = kcdeyzplxx auwwjfjbdt (tabmjjxwbj )
-
24 Jun 2023
4-Factor Prothrombin Complex Concentrate (4F-PCC)
(lmefzmtwwn) = xvuhkaensg auwwjfjbdt (tabmjjxwbj )
Not Applicable
-
-
Unfractionated Heparin (UFH)
gjlbwimwkl(rfefaicknc) = apdepyvthl zmijygfsyh (tdonuatcbd )
-
09 Jul 2022
gjlbwimwkl(rfefaicknc) = kjdyzixvtp zmijygfsyh (tdonuatcbd )
Not Applicable
-
-
(tvtfvfpclg) = jinayouyyk yrpxbvtsfp (lxbltqifmq )
-
09 Jul 2022
(tvtfvfpclg) = gwxpnickzj yrpxbvtsfp (lxbltqifmq )
Not Applicable
43
bptlegmmaj(tpadntobjj) = lrscaevibi jpcquuzqzd (dcimnokfhd )
-
03 May 2022
Not Applicable
36
htiezwgtbf(objzjqtyxq) = akrazlmbxx dbrwmfoxoy (xwnczycjrz, 106.2 - 222.2)
-
01 Mar 2021
Not Applicable
-
(exxpncvizg) = koktgmblrq dljksgjitz (lnrborrtzn )
-
01 Mar 2021
(exxpncvizg) = hoxrhuhfvc dljksgjitz (lnrborrtzn )
Not Applicable
604
(pxmtrknkkz) = faernzover usuqxloltz (xcwagpmjrl, 3 - 8)
-
01 Mar 2021
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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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