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


| 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 | 19 | qqkmrsjjme(mpsldznwcq) = hkeahzbpur wuiwhkrozb (ssebechtzb ) View more | Positive | 24 Sep 2026 | |||
Phase 3 | 132 | meaasjfqzf(aeujoenvxs) = pqdzxqgeut iqvdeatbfh (xqbhbfwdje, 2.6) View more | Positive | 14 Jul 2026 | |||
Not Applicable | 64 | xazydtlkpa(tfgdyipayh) = qjnpfegakw optbtbspjj (tjlkpggrqg ) View more | Positive | 14 Jul 2026 | |||
Phase 3 | 93 | jgylchclpm(eppydjdhgd) = gbrlfzlgxd yjhrjmxsko (ftsgnesmwk, 11.4) View more | Positive | 13 Jul 2026 | |||
Not Applicable | 50 | mxjbeyyrpm(fzwtcxfhsr) = In the 29 patients with available data, the median centralized FVIII:C trough level was 9 IU/dL (IQR: 6-15). A paired comparison conducted for 16 patients from the FVIII subgroup revealed significantly lower centralized CSA FVIII :C (median 7 IU/dL; IQR 5-10) compared to local OSA measurements (median 14 IU/dL; IQR 10-15; p < 0.01) across various reagents (Triniclot APTT HS, CK Prest, Pathromtin SL, Synthasil). erqxcaijqq (zuqdiljitw ) View more | Positive | 13 Jul 2026 | |||
(Patients previously on emicizumab) | |||||||
Not Applicable | - | 47 | (switched from SHL) | cyymlqsmfk(xcanxmsvtg) = zavdrpyspt tlxuglcklb (lolblvwtsd ) | Positive | 13 Jul 2026 | |
(switched from EHL) | cyymlqsmfk(xcanxmsvtg) = qumnibtkol tlxuglcklb (lolblvwtsd ) | ||||||
Not Applicable | 186 | azyzcfshcd(safpoibsnj) = nsqsukfkdp zqmudnjipf (mkmwdyuhxh ) View more | Positive | 13 Jul 2026 | |||
rFVIII prophylaxis | octiksnjrf(wnxhmcmckq) = zlcjkpixsd jkrkaskpvz (nytilypsov ) | ||||||
Not Applicable | 19 | dhzxhtbvel(jifmrsaykw) = tzleusgfoy zlssoaqlso (gbruswfnma ) View more | Positive | 13 Jul 2026 | |||
Not Applicable | 5 | kqvgetgtro(dgrcknmtgp) = The regimen was well tolerated, with no thromboembolic events or allergic reactions observed. uppxistpsn (rnzmsmugwy ) View more | Positive | 13 Jul 2026 | |||
Not Applicable | 11 | ubvuhiwmvz(vewizxdozm) = aatdvbsdea mdanuigcnj (kjjkmzzhem ) View more | Positive | 13 Jul 2026 |






