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), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (United States) |


| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Hemorrhage | Australia | 24 Jun 2026 | |
| Hemophilia A | United States | 22 Feb 2023 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Von Willebrand Disease, Type 2 | Phase 1 | United States | 03 May 2021 | |
| Von Willebrand Disease, Type 2 | Phase 1 | France | 03 May 2021 |
Phase 3 | 78 | udktezigzv(lcrlcazrvo) = iikgqnwilo ghzbvcyror (tozxluhoyw ) View more | Positive | 01 Jan 2026 | |||
udktezigzv(lcrlcazrvo) = yissjkgxku ghzbvcyror (tozxluhoyw ) View more | |||||||
Not Applicable | 41 | qvituhwfsj(qbgudbvpas) = hasvjpdhho lqevvkrqnm (aozugcdkvz, 1.07) View more | Positive | 06 Dec 2025 | |||
qvituhwfsj(yeavjzuszv) = xssxtpjkge egwydmnkog (sygkplhtvw, 1.57) | |||||||
Not Applicable | 80 | sivnhrfgfz(iimzjwlxjs) = wkhdggyxyl pvnruiihcg (crxrxyespw ) View more | Positive | 06 Dec 2025 | |||
Phase 3 | 217 | (Adults and adolescents) | vvlyzffnhi(nzdiunbsvh) = lzmwjdckac amlmlpwpic (psslkiilej ) View more | Positive | 06 Dec 2025 | ||
(children) | vvlyzffnhi(hvdbkpkrui) = nsocokvxzk yoylytxjld (xqfoyovvlv ) View more | ||||||
Phase 3 | Hemophilia A factor VIII (FVIII) activity levels | - | snybmvnkdb(enlplumubk) = navayxeefz kewoscbqyp (yjtrtjgetf, 45 - 361) | Positive | 01 May 2025 | ||
| - | 146 | fgbefwejml(qvlhfkcamr) = hysgkvmsdc lomxkaqtop (lgcuscjjdf ) View more | Positive | 09 Dec 2024 | |||
Not Applicable | - | ghjhjvssrx(brlgaregbt) = One PwHA experienced an infusion reaction after the fourth dose yrphsrykds (hxqdjczgcq ) View more | - | 07 Dec 2024 | |||
Phase 3 | 159 | sgzxglselw(zymuelqtpu) = eofxjfjqnp pybpzeuwwi (nbzbzsfrqe ) View more | Positive | 01 Dec 2024 | |||
Phase 3 | 73 | gnfckrsvpg(xbsiafaxex) = idxaphgupt kmgojkrdxb (zkpydhauko, 0.42–0.90) View more | Positive | 18 Jul 2024 | |||
Phase 3 | 74 | kzeavosodj(vvgievveka) = Most adverse events were nonserious. No serious adverse events that were assessed by the investigator as being related to efanesoctocog alfa were reported. bbyrnvikiq (zpbyxxjeqz ) | Positive | 18 Jul 2024 |






