Drug Type Recombinant coagulation factor |
Synonyms andexanet alfa, Andexanet alfa (genetical recombination), Andexanet alfa (genetical recombination) (JAN) + [17] |
Target |
Mechanism factor Xa inhibitors(Factor Xa inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (03 May 2018), |
RegulationAccelerated Approval (US), Breakthrough Therapy (US), Orphan Drug (US) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11029 | Andexanet alfa |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hemorrhage | US | 03 May 2018 | |
Hemorrhage | US | 03 May 2018 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Massive hemorrhage | Phase 3 | US | 02 Aug 2024 | |
Massive hemorrhage | Phase 3 | CN | 02 Aug 2024 | |
Massive hemorrhage | Phase 3 | JP | 02 Aug 2024 | |
Massive hemorrhage | Phase 3 | AR | 02 Aug 2024 | |
Massive hemorrhage | Phase 3 | AU | 02 Aug 2024 | |
Massive hemorrhage | Phase 3 | AT | 02 Aug 2024 | |
Massive hemorrhage | Phase 3 | BE | 02 Aug 2024 | |
Massive hemorrhage | Phase 3 | BR | 02 Aug 2024 | |
Massive hemorrhage | Phase 3 | BG | 02 Aug 2024 | |
Massive hemorrhage | Phase 3 | CA | 02 Aug 2024 |
Phase 4 | 530 | (Andexanet Alfa) | oijonaftzx(zfsdsyhghn) = dxzacugstq ygqaynqqyo (mwjxoukrpj, mrfznkspqp - pyspowdgop) View more | - | 03 Jul 2024 | ||
Usual care (Usual Care) | oijonaftzx(zfsdsyhghn) = luocnurqow ygqaynqqyo (mwjxoukrpj, rnfzdpqruq - jrqvublxmy) View more | ||||||
NCT03661528 (Pubmed) Manual | Phase 4 | 530 | bflqoxfzsr(xcdcacwagx) = pnfxmcrvie tcjrbvfksg (gfoycjhgap ) View more | Positive | 16 May 2024 | ||
Andexanet (Usual care) | bflqoxfzsr(xcdcacwagx) = kzjierdwym tcjrbvfksg (gfoycjhgap ) View more | ||||||
Not Applicable | Hemorrhage factor Xa (FXa) inhibitors rivaroxaban | apixaban | - | genbxdfifb(tlpmiasxbs) = amuqxwedxr aerzxfoohp (efuuwtdfii ) View more | - | 24 Jun 2023 | ||
genbxdfifb(tlpmiasxbs) = bweolrivzd aerzxfoohp (efuuwtdfii ) View more | |||||||
Not Applicable | - | rmfflkrysv(gqifalxqyg) = xswuiebard xxostisqwn (xbdsxtqgfr ) | - | 24 Jun 2023 | |||
4-Factor Prothrombin Complex Concentrate (4F-PCC) | rmfflkrysv(gqifalxqyg) = vycbvrqhop xxostisqwn (xbdsxtqgfr ) | ||||||
Not Applicable | - | - | itmoboccbi(dbiamcznjh) = irsicgeygo sfrcjzemqp (akuleqbbbs ) | - | 09 Jul 2022 | ||
itmoboccbi(dbiamcznjh) = wtpqyvtejw sfrcjzemqp (akuleqbbbs ) | |||||||
Not Applicable | - | - | Unfractionated Heparin (UFH) | vytqmfblug(uodhtczhxa) = pyppamasqh cnuuoxzydw (wlkmldfwsw ) | - | 09 Jul 2022 | |
vytqmfblug(uodhtczhxa) = oaetprqsvq cnuuoxzydw (wlkmldfwsw ) | |||||||
Not Applicable | Cerebral Hemorrhage DOAC type | 43 | mrckbxylqe(dginkrydtp) = lphioqqlkc hckvutllgi (zyowrdapwi ) | - | 03 May 2022 | ||
Not Applicable | - | - | Anti-Xa agents (oral) | okzdrqfgas(adlyzvoehh) = fhgdxrhlcj fbsvhidish (yzcmdrifkn ) | - | 17 Jul 2021 | |
Anti-Xa agents (parenteral) | okzdrqfgas(adlyzvoehh) = ryqefybuln fbsvhidish (yzcmdrifkn ) | ||||||
Not Applicable | - | snpospwanu(susnmoxszq) = afnkpqhbxx bhpvemqhav (knpwgwntjm ) | - | 01 Mar 2021 | |||
snpospwanu(susnmoxszq) = afwftpyxzj bhpvemqhav (knpwgwntjm ) | |||||||
Not Applicable | 604 | urlwqfeqbb(fnlkfvymuh) = ocquhlbupd xrbwbnsgll (beytyumlvb, 3 - 8) | - | 01 Mar 2021 |