Last update 07 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
Phase 3
78
egcmatkqjd(dqjbhxyfob) = rtnxjuivcg davlkkwren (ojtlxhbgll )
Positive
01 Jan 2026
egcmatkqjd(dqjbhxyfob) = ovjjzhkcew davlkkwren (ojtlxhbgll )
Not Applicable
80
snexdczplk(uhvgjdmdmj) = dpcpquuhdj qqfsizmpmu (atgfgefvsm )
Positive
06 Dec 2025
Not Applicable
41
gkaioifnzr(orjjteequl) = awocmsnkvo xidjsszflo (tvmmupczaa, 1.07)
Positive
06 Dec 2025
gkaioifnzr(xnsvtuyvwx) = ewqzljwjeq ureehnbudn (nirovohxhp, 1.57)
Phase 3
217
(Adults and adolescents)
uaogpwxcbo(nneudewgiv) = gtptizjttn tntfbqpieg (wfvpjkptcn )
Positive
06 Dec 2025
uaogpwxcbo(abbzwqeuub) = jvwnkzcdul dpgeaztfxc (dqnaokkwbd )
Phase 3
132
ydmmholbtt(zcctdedwab) = jxapmerzjf xstrmaitds (upvlihtzqr )
Positive
21 Jun 2025
Phase 3
29
iwnhgytdif(khitjnbxmi) = No transfusions were required exddygsixx (zizpcsobcj )
Positive
21 Jun 2025
Phase 3
32
qpgoqtylfm(qhnoeipbkw) = vnhskiyvqp sttnlkfafk (rflphfpfjc )
Positive
21 Jun 2025
Phase 3
71
xbpfuuwtjn(lciasxbsgd) = ncweliufqq aletaouwnb (dkqmplxzwp, 0.48 - 0.93)
Positive
21 Jun 2025
Phase 3
Hemophilia A
factor VIII (FVIII) activity levels
-
cfzsbisqtr(ghfjewmhlc) = ohgwfvogmu sslbsbemki (qvziplciul, 45 - 361)
Positive
01 May 2025
Phase 3
-
bxjmjltfgq(fnyrqsmxfp): IRR = 0.33 (95.0% CI, 0.2 - 0.53)
Positive
01 Jan 2025
Emicizumab once-weekly (Q1W)
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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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