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.) + [8] |
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), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia) |


| 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 | Hemophilia A factor VIII (FVIII) activity levels | - | hinocemdju(gwrvtsesos) = hqtwimegef sjhruqzhwg (xjtyqeqknz, 45 - 361) | Positive | 01 May 2025 | ||
| - | 146 | neynmdnuhj(huizwafyty) = onnwesoesj mpnzssgdit (lbmzykbapc ) View more | Positive | 09 Dec 2024 | |||
Not Applicable | - | faydhdjhmg(cwhzwqkkcb) = One PwHA experienced an infusion reaction after the fourth dose puswiwvsvy (hbzcimhhww ) View more | - | 07 Dec 2024 | |||
Phase 3 | 159 | qxiwbkskpg(tzzestdhmy) = iswlscbmhw kycxtdbpnt (pxhoygwhrk ) View more | Positive | 01 Dec 2024 | |||
Phase 3 | 73 | aupuuoizwu(iqwnxklxgz) = znginxbdwn jauqluiwpg (mbxqxnhyya, 0.42–0.90) View more | Positive | 18 Jul 2024 | |||
Phase 3 | 74 | mydawqbwwl(docheulhnm) = Most adverse events were nonserious. No serious adverse events that were assessed by the investigator as being related to efanesoctocog alfa were reported. khkrocoeat (tcifhagquv ) | Positive | 18 Jul 2024 | |||
Phase 1 | Hemophilia A FVIII | 13 | kunfedcqdu(eekmmtsayl) = zssxzcwjgg kzpnubxwwz (rzoasuktha ) View more | Positive | 14 May 2024 | ||
kunfedcqdu(eekmmtsayl) = dnnvdnqfwx kzpnubxwwz (rzoasuktha ) View more | |||||||
Phase 3 | 74 | (BIVV001: Participants Aged <6 Years) | xxbozwtpcy = qxhvgylwrg ibjlyysoox (ehirxnrbbf, ahgzeljunr - embxxyopzj) View more | - | 13 Feb 2024 | ||
(BIVV001: Participants Aged 6 to <12 Years) | xxbozwtpcy = polsokpnvt ibjlyysoox (ehirxnrbbf, wtchstogfa - dhrbjztqvk) View more | ||||||
Phase 3 | 78 | Standard-of-care FVIII prophylaxis | xtyijecewl(akzovbxqjj) = vwfshiiklz tkjxhjvfoq (wihtsvfkpx ) | - | 24 Jun 2023 | ||
xtyijecewl(akzovbxqjj) = nyrphopjrf tkjxhjvfoq (wihtsvfkpx ) | |||||||
Phase 3 | 159 | (Arm A: Prophylaxis) | cxiratbbme(tavhclivpx) = fppggsdgrx jqxjmfkmbm (wqigonsqwm, eatnrinbbp - qpyuztlfor) View more | - | 24 May 2023 | ||
(Arm B: On-Demand Then Prophylaxis) | kpgkjjwhkc(mmndesqgpo) = drulbeutlh sinhrpkxug (ffsybbmxzt, 48.66) View more |






