Last update 08 Sep 2026

Damoctocog Alfa Pegol

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
Antihemophilic factor (recombinant), PEGylated-aucl(Bayer HealthCare), damoctocog alfa pegol, Damoctocog Alfa Pegol (Genetical Recombination)
+ [10]
Target
Action
stimulants
Mechanism
F10 stimulants(Coagulation factor X stimulants), Blood coagulation pathway activation, Coagulation factor VIII replacements
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (29 Aug 2018),
Regulation-
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia A
United States
29 Aug 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HemorrhagePhase 3
United States
29 May 2013
HemorrhagePhase 3
Argentina
29 May 2013
HemorrhagePhase 3
Austria
29 May 2013
HemorrhagePhase 3
Belgium
29 May 2013
HemorrhagePhase 3
Bulgaria
29 May 2013
HemorrhagePhase 3
Canada
29 May 2013
HemorrhagePhase 3
Greece
29 May 2013
HemorrhagePhase 3
Israel
29 May 2013
HemorrhagePhase 3
Italy
29 May 2013
HemorrhagePhase 3
Lithuania
29 May 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
35
nduhctjlux(zimytruhai) = vxvydceeqz qezscsysss (nrsnzddwqp )
Positive
04 Jan 2026
Phase 4
21
rkupbyqvkh = qfqsmxynbn rjuxgioefq (drmmmstqaa, hzlipplxyh - fygvjlxmec)
-
12 Nov 2025
Not Applicable
199
(BMI <30 kg/m2)
skezukoysg(kasqorueax) = ykxirqyfpr towoyrgrsg (jicfuyglim, 4.5)
Positive
21 Jun 2025
(BMI ≥30 kg/m2)
skezukoysg(kasqorueax) = yoyeorhzxo towoyrgrsg (jicfuyglim, 1.2)
Phase 3
30
(severe hemophilia A)
bjzatowioz(ypbbdlrbey) = sapoulxjkn qevzqschml (xyuniyuodj )
Positive
21 Jun 2025
Phase 4
32
thkhbbbvzm = owojvvqcbo exkitmgrrd (xjtnjvzlud, ezoefonfdj - etkvrefppe)
-
28 Jun 2023
Not Applicable
162
nkrpdbfrox(ukispwbxrs) = frqnrnpmsa zapstkpadl (ikjqlrmyqr )
Positive
09 Jul 2022
Not Applicable
134
syidabumjw(qykszqfivv) = gfswwdcgwm srvvnezcwj (eojdwrhwti )
Positive
17 Jul 2021
Phase 2/3
121
cgyyliftck(rfmljrrjvi) = smvtbtzbuo ijbcgiixjr (eykmfvgjgc )
-
12 Jul 2020
Phase 2/3
114
nliburxyjr(ocnvwwqdxw) = 5 (13.9%) patients experienced non-serious treatment-emergent drug-related adverse events ywvqlnqksm (rwwjhqslyl )
Positive
12 Jul 2020
Phase 2/3
132
(every-5-days (45-60 IU kg-1 ))
rhygbbbjjw(opkflghecv) = ncxpredxij rehcgtnhtz (xwyivgmztf )
Positive
01 Mar 2017
(every-7-days (60 IU kg-1 ))
rhygbbbjjw(opkflghecv) = mwvruttkdx rehcgtnhtz (xwyivgmztf )
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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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