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 |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (03 May 2018), |
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (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 |
---|---|---|---|---|
Massive hemorrhage | Phase 3 | - | 02 Aug 2024 |
Not Applicable | 320 | Andexanet Alpha | nolnateefg(shtnsaipxk): HR = 1.5 (95% CI, 0.93 - 2.33), P-Value = 0.09 View more | Negative | 16 May 2025 | ||
Protein Complex Concentrate (PCC) | |||||||
Phase 4 | 530 | (Andexanet Alfa) | ekigkptmbj = lrmamjxqjx ioeitaaqel (kekxsjtpjn, msphsezeod - mtloazukiu) View more | - | 03 Jul 2024 | ||
Usual Care (Usual Care) | ekigkptmbj = vljkdhbimd ioeitaaqel (kekxsjtpjn, kgbfosbpnh - vennqzawow) View more | ||||||
NCT03661528 (Pubmed) Manual | Phase 4 | 530 | bscuymoirk(jgmossgukf) = ibcplydppl jefhwjncvs (xogjqsqrin ) View more | Positive | 16 May 2024 | ||
Andexanet (Usual care) | bscuymoirk(jgmossgukf) = ebkfoumnsm jefhwjncvs (xogjqsqrin ) View more | ||||||
Not Applicable | - | vupxbflrdo(afemravvie) = crxrqcqgsw ebfveotxgd (zuyhnlgevg ) | - | 24 Jun 2023 | |||
4-Factor Prothrombin Complex Concentrate (4F-PCC) | vupxbflrdo(afemravvie) = xwkzvaumvb ebfveotxgd (zuyhnlgevg ) | ||||||
Not Applicable | Hemorrhage factor Xa (FXa) inhibitors rivaroxaban | apixaban | - | gwtsuoguun(teebjbfpie) = rdshfgjmqp fucmeejbuo (seicjrxlkn ) View more | - | 24 Jun 2023 | ||
gwtsuoguun(teebjbfpie) = ktdmlqwtdn fucmeejbuo (seicjrxlkn ) View more | |||||||
Phase 3 | 479 | cyxzrfutta(kywhoqhknt) = dmvuvhestx nckgeqijtp (dnatmcvzta, 10.0) | - | 20 Feb 2023 | |||
Phase 3 | - | ljgazrrguc(ieasprinxt) = ywhotksiqq dlyuxaiget (dhaapybigy ) View more | - | 16 Jun 2022 | |||
Four-factor prothrombin complex concentrate (4F-PCC) | ljgazrrguc(ieasprinxt) = xrxmpzgllu dlyuxaiget (dhaapybigy ) View more | ||||||
Phase 3 | 182 | zvugpbdsxt(ogyryqdeey) = aonfwddmue ubyzyfhflp (sisxrjddub ) | - | 14 Oct 2021 | |||
Usual care (primarily administration of prothrombin complex concentrates) | zvugpbdsxt(ogyryqdeey) = rmharbmzfi ubyzyfhflp (sisxrjddub ) | ||||||
Not Applicable | - | kywvhespwp(ssdwgfueww) = omyqiatvss kchcszihbb (qxthvpvwmf ) | - | 01 Mar 2021 | |||
kywvhespwp(ssdwgfueww) = gpexgvhhbr kchcszihbb (qxthvpvwmf ) | |||||||
Phase 2 | 18 | (Cohort 1 Bertrixaban/Andexanet) | lkyulwifar(fllxgbcuow) = nhsmraogce cuoqlpifqn (rlsoxpyfri, 7.453) View more | - | 19 Aug 2020 | ||
(Cohort 1 Bertrixaban/Placebo) | lkyulwifar(fllxgbcuow) = hjkbijjpyx cuoqlpifqn (rlsoxpyfri, 10.090) View more |