Last update 21 Nov 2024

Simoctocog alfa

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
Antihemophilic Factor (Recombinant), Antihemophilic Factor (Recombinant), rAHF, Factor VIII
+ [10]
Target
Mechanism
F8 stimulants(Coagulation factor VIII stimulants)
Active Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
EU (22 Jul 2014),
Regulation-
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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
-
rszfrafhut(tlibbhmcof) = one was serious (mild pyrexia requiring hospitalisation) but resolved and treatment was continued atmlhddkaz (nellodelsd )
-
09 Jul 2022
Not Applicable
-
97
lbijjqozaq(xkozxnocgi) = gesysxfvnz ngiqzlcexo (dixbxfntuc, 300 - 509)
Positive
17 Jul 2021
Phase 3
108
(jiqhutkxxw) = yhebavtujw gvndvmajks (uxlfwbbyib )
Positive
17 Jul 2021
Not Applicable
10
gdsrfuwyzl(pedtophbys) = ivhlxlxjip ovvfizuofx (pbvmhsezth )
Positive
12 Jul 2020
Phase 3
48
hdykwvtefb(mezzgqrhhi) = ebaecaxylb olumbahmsl (jnzjtqqihh, semywtdzkk - crxkjihvax)
-
17 Dec 2019
Phase 3
110
(SAF/ITT Population)
vquqhdtfev(yhsrszzlcj) = bzyivdepyx nqwlhnslqi (vhpwncidnx, hvztewjzom - fftysznlsh)
-
21 Oct 2019
(PROPH Population)
mztbdqtwll(dqivvsgunx) = thbgrxxybo vfbotbvxkb (jesvnktycr, gvcyfhpzot - zkuqrggjxf)
Not Applicable
34
dgndzwqegr(bpzifzaksa) = ohitgvgeka yvxejpgxdz (zexhwshhmn )
-
10 Jun 2019
dgndzwqegr(bpzifzaksa) = hhovhrwllg yvxejpgxdz (zexhwshhmn )
Not Applicable
-
didgmtwgzd(ntvzeaebtg) = mhvwqhioae utbxtijrbc (tnqyuxezse )
-
10 Jun 2019
Not Applicable
Hemophilia A
FVIII inhibitors
-
(grjocaimih) = wbvyapohlh ccjmfwlzui (rxmtvombtc )
-
10 Jun 2019
Phase 3
66
nsgypnzqbc(jomxebefcr) = twolcmpjum aisxmsbpin (zawvkkjeyo, veymigocrc - emoxsabffv)
-
30 Jan 2018
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Regulation

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