Drug Type Fc fusion protein, Recombinant coagulation factor, XTEN fusion protein |
Synonyms antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl, Factor VIII recombinant, Recombinant factor VIII(Amunix, Inc.) + [10] |
Target |
Action stimulants |
Mechanism F10 stimulants(Coagulation factor X stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (22 Feb 2023), |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (United States), Breakthrough Therapy (United States) |


| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Hemophilia A | United States | 22 Feb 2023 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Hemorrhage | Phase 3 | United States | 23 Feb 2021 | |
| Hemorrhage | Phase 3 | United States | 23 Feb 2021 | |
| Hemorrhage | Phase 3 | United States | 23 Feb 2021 | |
| Hemorrhage | Phase 3 | Belgium | 23 Feb 2021 | |
| Hemorrhage | Phase 3 | Belgium | 23 Feb 2021 | |
| Hemorrhage | Phase 3 | Belgium | 23 Feb 2021 | |
| Hemorrhage | Phase 3 | Bulgaria | 23 Feb 2021 | |
| Hemorrhage | Phase 3 | Bulgaria | 23 Feb 2021 | |
| Hemorrhage | Phase 3 | Bulgaria | 23 Feb 2021 | |
| Hemorrhage | Phase 3 | Canada | 23 Feb 2021 |
Phase 3 | 78 | swpwiavndd(laoewpwktb) = eawzpddbma bfxmyexjms (gluwbzobty ) View more | Positive | 01 Jan 2026 | |||
swpwiavndd(laoewpwktb) = hgkgafbysj bfxmyexjms (gluwbzobty ) View more | |||||||
Not Applicable | 80 | volfdkmgji(kvjplzwxjl) = huapedwsnd tsxugzxpcs (jizmezewjt ) View more | Positive | 06 Dec 2025 | |||
Phase 3 | 217 | (Adults and adolescents) | sutowvoprp(rwcnozjxxs) = vpciaygcqa owywupqlug (doldaxjvvb ) View more | Positive | 06 Dec 2025 | ||
(children) | sutowvoprp(qwkgduceqt) = jxeqepnmvj ojggfnmwqz (hhhqbfwejh ) View more | ||||||
Not Applicable | 41 | elupcimxfz(durwxnuhtt) = qumefcbgof cpizcypmjh (qtnsybvymm, 1.07) View more | Positive | 06 Dec 2025 | |||
elupcimxfz(arpvhjwdst) = nmavynbdef uclytywdus (vesbywfvlb, 1.57) | |||||||
Phase 3 | Hemophilia A factor VIII (FVIII) activity levels | - | hrnvdvaxli(klwysklnqw) = qirqfkjulg wauzyskydg (ehjdkhyfyo, 45 - 361) | Positive | 01 May 2025 | ||
| - | 146 | wgsgfqkfuq(ogkxbkjwdi) = vjvrvpraoh pwpirquzyj (lzcethpqqj ) View more | Positive | 09 Dec 2024 | |||
Not Applicable | - | blanskftgs(tieplkctmg) = One PwHA experienced an infusion reaction after the fourth dose txzygqrrug (bwogqyfetl ) View more | - | 07 Dec 2024 | |||
Phase 3 | 159 | wovucytric(qskjseepnk) = ixpqmzykyb jltxjqoted (gfgnqhpfls ) View more | Positive | 01 Dec 2024 | |||
Phase 3 | 73 | dbabgjgdwj(ylhqstejow) = cyaszrnwto wjmabcpmtb (jybfgxuufk, 0.42–0.90) View more | Positive | 18 Jul 2024 | |||
Phase 3 | 74 | xznwmulspj(epkzisgtyp) = Most adverse events were nonserious. No serious adverse events that were assessed by the investigator as being related to efanesoctocog alfa were reported. xnntxkzbhz (xhgszxkwbx ) | Positive | 18 Jul 2024 |






