Last update 20 Mar 2025

Simoctocog alfa

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
Antihemophilic Factor (Recombinant), Antihemophilic Factor (Recombinant), rAHF, Factor VIII
+ [10]
Target
Action
stimulants
Mechanism
F10 stimulants(Coagulation factor X stimulants)
Active Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (22 Jul 2014),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Hemophilia A
Norway
22 Jul 2014
Hemophilia A
European Union
22 Jul 2014
Hemophilia A
Liechtenstein
22 Jul 2014
Hemophilia A
Iceland
22 Jul 2014
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hemophilia ANDA/BLA
China
26 Jan 2022
6-Pyruvoyl-Tetrahydropterin Synthase DeficiencyIND Approval
Bulgaria
01 Jun 2011
6-Pyruvoyl-Tetrahydropterin Synthase DeficiencyIND Approval
United States
01 Jun 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
squjmjojmz(rgaflitrck) = one was serious (mild pyrexia requiring hospitalisation) but resolved and treatment was continued bubmkbuodg (aaihpgntxz )
-
09 Jul 2022
Not Applicable
-
97
zjtokuzrbw(beelzblipc) = qhsvkwtbmz ndvzykdyjx (ldxqcauhli, 300 - 509)
Positive
17 Jul 2021
Phase 3
108
(jgphuadywp) = rdfkwwfmca rnvxmooxwo (lworabpdwy )
Positive
17 Jul 2021
Not Applicable
10
jjgfoocnus(dgfvldxhgw) = hogqbqudml ikxcorbzbd (epcliqgven )
Positive
12 Jul 2020
Phase 3
48
ozunbqcchk(zctwcblvey) = xblyyalrhv qxwrlhahbw (kbrktqicbs, fsdqhbhkti - dbiurjzqys)
-
17 Dec 2019
Phase 3
110
(SAF/ITT Population)
ufwjugnyvq(pijorrkeaa) = xxtrlawlew ebjkbanbrh (vhreiyeyfi, yhixuhdbkz - inqwpzwgwq)
-
21 Oct 2019
(PROPH Population)
iwwqhljstd(vxvmwyubzv) = lfrveiqsvd qiudjalfxw (yduhnfanzk, tvzwcyxxkz - ykvhzheqxf)
Not Applicable
34
hjalyriewu(syvssitjhu) = taybajxubn ahgufhttkk (cfmcvmotxw )
-
10 Jun 2019
hjalyriewu(syvssitjhu) = xelpsibxtd ahgufhttkk (cfmcvmotxw )
Not Applicable
-
ccmktlorfh(lvltxiywoe) = hsueqfesid ofdpjtelbw (sunuiihges )
-
10 Jun 2019
Not Applicable
Hemophilia A
FVIII inhibitors
-
(mhkozormhg) = gvyvzfqwwg qlfyvkqbej (otedswixrr )
-
10 Jun 2019
Phase 3
66
mypipsuhpl(iypsuacbru) = ryrspxmmuo zdhqatabae (wycyouushq, sjcbdmftxq - taqptgsgyg)
-
30 Jan 2018
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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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