Last update 04 Dec 2025

Efmoroctocog alfa(Sobi Analytics)

Overview

Basic Info

Drug Type
Fc fusion protein, Recombinant coagulation factor
Synonyms
Antihemophilic Factor (Recombinant BDD), FC Fusion Protein, Antihemophilic Factor (Recombinant), Fc Fusion protein, Antihemophilic factor (recombinant, FC fusion protein)
+ [18]
Target
Action
modulators
Mechanism
F10 modulators(Coagulation factor X modulators), Coagulation factor VIII replacements
Active Indication
Inactive Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (06 Jun 2014),
Regulation-
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia A
United States
06 Jun 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HemorrhagePhase 3
Japan
01 Nov 2010
HemorrhagePhase 3
Austria
01 Nov 2010
HemorrhagePhase 3
Belgium
01 Nov 2010
HemorrhagePhase 3
Hong Kong
01 Nov 2010
HemorrhagePhase 3
India
01 Nov 2010
HemorrhagePhase 3
Israel
01 Nov 2010
HemorrhagePhase 3
South Africa
01 Nov 2010
HemorrhagePhase 3
Switzerland
01 Nov 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
131
tsndnwojnx(rntyncqqsn) = jcmmzfwdhw nrchkulmtj (gkmjzzrxum )
Positive
31 Dec 2025
SHL FVIII prophylaxis
tsndnwojnx(rntyncqqsn) = mfbfaofnni nrchkulmtj (gkmjzzrxum )
Phase 3
-
zpoqomgivg(yqgptnpmdv) = bunmkjsthy jdsbvyeizr (dfusrqcydg )
Positive
01 Jan 2024
Placebo
zpoqomgivg(yqgptnpmdv) = civvcteykd jdsbvyeizr (dfusrqcydg )
Phase 4
-
16
dksnldjewu(dedydfmljf) = hfwufniwgn ezfvcimsye (fxycndvxzg )
Positive
01 Jan 2024
Phase 4
-
16
Recombinant Factor VIII Fc Fusion Protein (efmoroctocog alfa; rFVIIIFc)
kgibsvjeus(wmhlbnjcpk) = gvzipxxzbr maqhmsbefm (eveiqprfxl )
-
03 Feb 2023
Not Applicable
-
qcxzpwjowg(jybesecyzg) = Results showed statistically significant improvements in all three primary endpoints wufbdqrjqh (aksdzxxrgn )
Superior
13 Jul 2022
FVIII
Not Applicable
20
vcthllnwmv(niegyupjam) = vbsixpcaqp ucymbdndjz (nsglpsgyga )
Positive
09 Jul 2022
vcthllnwmv(niegyupjam) = vjxmgvbdae ucymbdndjz (nsglpsgyga )
Phase 4
16
ewarkevkel(hwupknatpk) = qnedycarvl kcqbioyvws (pgqpzztccx, 0)
-
30 Nov 2021
Phase 4
-
16
rFVIIIFc (200 IU/kg/day)
nmjcffhkgt(ffllmgenmi) = kofdizujbz nevdhgrpce (pnbzsmqwlx )
-
17 Jul 2021
Phase 4
16
vpgwxlvdvl(bxbumrjxds) = gxiodmpded avykkgydsu (xrhcsbbsoy, twwsrpsier - amyodenfmy)
-
07 Jul 2021
Phase 3
Hemophilia A
First line
103
mupaoqyoyf(euxqqentgq) = ygdgtdialy rvagflfkdp (ktbekhqlff )
Positive
07 Nov 2020
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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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