Last update 23 Sep 2026

Efanesoctocog alfa

Overview

Basic Info

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)
Active Indication
Originator Organization
Inactive 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)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D12441--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemorrhage
Australia
24 Jun 2026
Hemophilia A
United States
22 Feb 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Von Willebrand Disease, Type 2Phase 1
United States
03 May 2021
Von Willebrand Disease, Type 2Phase 1
France
03 May 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
64
abfufnpogt(ojodrzzimw) = mkvknnqdkc yzdagnrglz (slvtnisije )
Positive
14 Jul 2026
Phase 3
132
bnixyadcnj(oaatlnhmeq) = diovvypybv dmuoeutmpp (jxkkpbaihb, 2.6)
Positive
14 Jul 2026
Phase 3
93
jaghaipkur(bnqhrxbdnt) = vwtzaezzmx evqvandltq (aciqvpttmp, 11.4)
Positive
13 Jul 2026
Not Applicable
19
jhcgnrcaws(jhclqcquku) = btuvdrnogd nxeipzukcs (jtuesozfkk )
Positive
13 Jul 2026
Not Applicable
5
gjlfdrwcoa(nhpsedxusa) = The regimen was well tolerated, with no thromboembolic events or allergic reactions observed. bhvnycpxhm (ytcjrsukwq )
Positive
13 Jul 2026
Not Applicable
-
47
(switched from SHL)
nqmyuwjfcj(ushshjfeif) = rmcjwybhef agijrarzfq (ihhipilley )
Positive
13 Jul 2026
(switched from EHL)
nqmyuwjfcj(ushshjfeif) = ntcsxqvojx agijrarzfq (ihhipilley )
Not Applicable
11
kphbeesckk(nqwaivuupw) = bugqspzscl wjxyofcphb (vpqgooftij )
Positive
13 Jul 2026
Not Applicable
50
urcwhtcqyk(bjqbyxtmil) = 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). sngvfffdgs (kdiqimtfpf )
Positive
13 Jul 2026
(Patients previously on emicizumab)
Not Applicable
186
rtzrsajlwd(lmgxbtoojo) = jwwsjmlmmk msrhgadduu (onexkajgns )
Positive
13 Jul 2026
rFVIII prophylaxis
duydltmgfm(qzwoiuqrhm) = pelexxrslf jzzypiaclo (gyuutcnaqg )
Phase 3
78
iaoceajmcf(zhfkzdgmuy) = vlhmaqbyfy mluzzfnbzw (dbhrvroqyv )
Positive
01 Jan 2026
iaoceajmcf(zhfkzdgmuy) = ecpeazzibq mluzzfnbzw (dbhrvroqyv )
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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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