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 |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (03 May 2018), |
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Accelerated Approval (United States) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11029 | Andexanet alfa |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hemorrhage | United States | 03 May 2018 | |
Hemorrhage | United States | 03 May 2018 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hemorrhage | NDA/BLA | China | 16 Dec 2023 | |
Hemorrhage | NDA/BLA | China | 16 Dec 2023 | |
Hemorrhage | NDA/BLA | China | 16 Dec 2023 | |
Massive hemorrhage | Phase 2 | Japan | 02 Aug 2024 | |
Massive hemorrhage | Phase 2 | Australia | 02 Aug 2024 | |
Massive hemorrhage | Phase 2 | New Zealand | 02 Aug 2024 | |
Massive hemorrhage | Phase 2 | Spain | 02 Aug 2024 | |
Massive hemorrhage | Phase 2 | Slovenia | 02 Aug 2024 | |
Massive hemorrhage | Phase 2 | Slovakia | 02 Aug 2024 | |
Massive hemorrhage | Phase 2 | United Kingdom | 02 Aug 2024 |
Phase 4 | 530 | (Andexanet Alfa) | huecszbsdd(jdgkqqzimr) = nucjsohafz wnwygieerp (rriavivhue, ajbpxxknjr - nqezmsvetl) View more | - | 03 Jul 2024 | ||
Usual care (Usual Care) | huecszbsdd(jdgkqqzimr) = npqkfawomr wnwygieerp (rriavivhue, sxcrwwdjkc - dcqiaqdjoc) View more | ||||||
NCT03661528 (Pubmed) Manual | Phase 4 | 530 | (qfxohgchcq) = wrvkntnbbh ehvamcccov (djqetzgcep ) View more | Positive | 16 May 2024 | ||
Andexanet (Usual care) | (qfxohgchcq) = qhvlrrmttm ehvamcccov (djqetzgcep ) View more | ||||||
Not Applicable | Hemorrhage factor Xa (FXa) inhibitors rivaroxaban | apixaban | - | ipkmrlduxx(kmqxneglet) = vvotlvkrsy lynxbderuz (tozwqnwlqu ) View more | - | 24 Jun 2023 | ||
ipkmrlduxx(kmqxneglet) = wjimdbrwsm lynxbderuz (tozwqnwlqu ) View more | |||||||
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 | Cerebral Hemorrhage DOAC type | 43 | bptlegmmaj(tpadntobjj) = lrscaevibi jpcquuzqzd (dcimnokfhd ) | - | 03 May 2022 | ||
Not Applicable | 36 | htiezwgtbf(objzjqtyxq) = akrazlmbxx dbrwmfoxoy (xwnczycjrz, 106.2 - 222.2) View more | - | 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 |