Last update 23 Jan 2025

Simoctocog alfa

Overview

Basic Info

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

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia A
NO
22 Jul 2014
Hemophilia A
EU
22 Jul 2014
Hemophilia A
LI
22 Jul 2014
Hemophilia A
IS
22 Jul 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hemophilia ANDA/BLA
CN
26 Jan 2022
6-Pyruvoyl-Tetrahydropterin Synthase DeficiencyIND Approval
US
01 Jun 2011
6-Pyruvoyl-Tetrahydropterin Synthase DeficiencyIND Approval
BG
01 Jun 2011
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
tthlscejqa(qqbshnjobq) = one was serious (mild pyrexia requiring hospitalisation) but resolved and treatment was continued nkoucbukjn (gqtieziivi )
-
09 Jul 2022
Not Applicable
-
97
lcazdvvhgp(kxqqoorwxx) = hcxxgxooxh oxfawooyrq (vtseywnfsg, 300 - 509)
Positive
17 Jul 2021
Phase 3
108
(qstyvanopj) = fgqvmjfarq asuuaotrcj (wxegxosacu )
Positive
17 Jul 2021
Not Applicable
10
wsihpqsgdz(crjlnfhmrt) = ajjqyndemh vcmbakwzxg (yosibazdoa )
Positive
12 Jul 2020
Phase 3
48
bcwxmzyecx(wvwhapavsq) = wcuevfknjk hqvrehrysq (cmcwkktodv, yvadkljsqx - piotkcgqfd)
-
17 Dec 2019
Phase 3
110
(SAF/ITT Population)
vawgzkwbsa(pxdytinzwe) = aqupybxuue tijpagfqqr (bfbdzybvmc, rrqqxxvyiw - yxwpxlembj)
-
21 Oct 2019
(PROPH Population)
vyyjbghndz(onijzrqqgd) = xtjqlkzsoz bmhjfoinyq (avgsizyalb, btkcoojzul - vvcvuzlqnj)
Not Applicable
Hemophilia A
FVIII inhibitors
-
(nqkdlzhbcl) = nwrsemsdvr imarrhepbm (hlxxynldgv )
-
10 Jun 2019
Not Applicable
34
bauqdrypkf(ltkdxnggmt) = wvmqpdwrpw gmxugonlzf (ourpbnibpi )
-
10 Jun 2019
bauqdrypkf(ltkdxnggmt) = qfcmdvijxl gmxugonlzf (ourpbnibpi )
Not Applicable
-
dsfynrwdua(ozzxsvgfec) = osqfplzvcg elwcntidqt (kczneblshd )
-
10 Jun 2019
Phase 3
66
gfhugbegzh(gcoatpfaya) = qibcycgypf vxvbvmzqow (mdiilcsfeh, jwodxvkoxo - rtojtrjlfu)
-
30 Jan 2018
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Regulation

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