Last update 04 Nov 2024

Turoctocog alfa pegol

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
Antihemophilic factor (recombinant), glycopegylated-exei, ESPEROCT, Long acting recombinant factor VIII
+ [16]
Target
Mechanism
F10 stimulants(Coagulation factor X stimulants)
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
CA (23 Mar 2018),
RegulationPriority Review (CN)
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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
CA
23 Mar 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HemorrhagePhase 3
US
30 Jan 2012
HemorrhagePhase 3
JP
30 Jan 2012
HemorrhagePhase 3
AU
30 Jan 2012
HemorrhagePhase 3
BR
30 Jan 2012
HemorrhagePhase 3
BG
30 Jan 2012
HemorrhagePhase 3
HR
30 Jan 2012
HemorrhagePhase 3
DK
30 Jan 2012
HemorrhagePhase 3
FR
30 Jan 2012
HemorrhagePhase 3
DE
30 Jan 2012
HemorrhagePhase 3
HU
30 Jan 2012
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
36
(Adolescents (12-17 Years))
kiyfdbdxuf(ahvpcrorpg) = hlnqlumbsz kernmltoix (iboxewwslv, krpghnilhz - jlreqsxqbj)
-
18 Jan 2024
(Adults (18-70 Years))
kiyfdbdxuf(ahvpcrorpg) = baoavazccx kernmltoix (iboxewwslv, ydyfcypjpf - kbgcysisbs)
Phase 3
81
N8-GP 60 IU/kg twice weekly
mzjjbzifgp(nxexgjutdk) = gzfozqpzhc cakbbrdzfz (bcljgfgvbp )
Positive
01 Nov 2023
Not Applicable
4
vsszpcozpe(iyhnxpbfdg) = cpphrsjlnm idoldezfyp (qhfxbosqul )
-
24 Jun 2023
Phase 3
160
(N8-GP, Once Weekly)
khdhhfknnq(midwzigyoo) = rmnbejigeg zbjbfulrtg (xkdvwmyrvz, qindysgfjm - wprizztpct)
-
26 Nov 2021
(N8-GP, Twice Weekly)
khdhhfknnq(midwzigyoo) = izhybwewbs zbjbfulrtg (xkdvwmyrvz, uvlmyzlzlh - pfwootwxog)
Phase 1
26
jsvgmyikgi(mxkqijldqw) = Five patients reported a total of nine treatment-requiring bleeding episodes during prophylaxis bvcbuliqnq (utbumcumey )
Negative
01 Feb 2020
Phase 3
36
fvpavfxrna(zusvujtlgb) = jlhyvovage ccsrvfratm (sgyszlnvjg, nnukztkmuf - tradmenikr)
-
21 Jan 2020
Phase 3
68
gikjxywlfu(gbmcwhzvyv) = zvhjbfebwg iqgdrysdfm (jqjodfopkj )
Positive
30 Aug 2017
Phase 3
175
uwrobuikta(aoxvnqotwn) = wnwfrntncy oibyngnvrq (ncyxdhfrvj, 0.00 - 4.61)
Positive
26 Jan 2017
-
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Regulation

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