Last update 14 Apr 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
European Union
22 Jul 2014
Hemophilia A
Iceland
22 Jul 2014
Hemophilia A
Liechtenstein
22 Jul 2014
Hemophilia A
Norway
22 Jul 2014
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
6-Pyruvoyl-Tetrahydropterin Synthase DeficiencyPhase 3
United States
01 Jun 2011
6-Pyruvoyl-Tetrahydropterin Synthase DeficiencyPhase 3
Bulgaria
01 Jun 2011
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
Personalized Prophylaxis with Simoctocog Alfa
bfzjzluyih(rbrppwnnks) = gxdoaervyz ebldbazmco (zicnmosdnv )
Positive
24 Jun 2023
Standard Prophylaxis with Turoctocog Alfa
bfzjzluyih(rbrppwnnks) = awqkwtvszi ebldbazmco (zicnmosdnv )
Not Applicable
-
azwjrpzlnz(ivbewtlrau) = one was serious (mild pyrexia requiring hospitalisation) but resolved and treatment was continued jqhnriszwi (xxdejjixeh )
-
09 Jul 2022
Phase 3
108
poltdtnwiy(myjpcolbbo) = ozxjlvestl ssarneeyoo (lmewkuazeb )
Positive
17 Jul 2021
Not Applicable
-
97
lxetfwadgq(yelajpfezo) = ugovjqrbdb iddfrsdjbz (xlhjahueli, 300 - 509)
Positive
17 Jul 2021
Not Applicable
10
ldodazwnzr(rjxpwogtoa) = erwzextdmk orhfecclfd (ckunkwpiem )
Positive
12 Jul 2020
Phase 3
48
xitnkaiuph = fgctumniwy eckwamuonu (mbxddwokmz, hmhzabghdf - fispxdgaus)
-
17 Dec 2019
Phase 3
110
(SAF/ITT Population)
vxvicxokfg = grlajsrgfh rzxbsadmwh (khzpolshsz, kiaxospvxb - nnzbpqzwje)
-
21 Oct 2019
(PROPH Population)
vqfrqhfsgc(nfywvjmmcs) = mbsrcrwxmw biwowgcmyo (vfibkfohsw, wudwjpmkyu - jtdtuqzhom)
Not Applicable
-
ckomhtemum(ywuuowxfet) = ootmiwpmbr mwfuibpylp (aaijydfovv )
-
10 Jun 2019
Not Applicable
34
nmvrjvoevl(fergdqghae) = wlwozstkjw krwevgveqh (llvfstygfx )
-
10 Jun 2019
nmvrjvoevl(fergdqghae) = ehgugvomls krwevgveqh (llvfstygfx )
Not Applicable
1,099
rAHF ITI therapy
mtvjxysjex(soawihevji) = adpiqhhhcz obgbstatdt (aanmnqvssa )
Positive
10 Jun 2019
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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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