Last update 26 May 2025

Human prothrombin complex(CSL bering)

Overview

Basic Info

Drug Type
Non-recombinant coagulation factor
Synonyms
4-factor PCC, 4-factor prothrombin complex concentrate, Beriplex
+ [7]
Action
modulators
Mechanism
F10 modulators(Coagulation factor X modulators), factor IX modulators(Coagulation factor IX modulators), factor VII modulators(Coagulation factor VII modulators)
Therapeutic Areas
Active Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (29 Apr 2013),
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
Hemorrhage
United States
29 Apr 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Wounds and InjuriesPhase 3
United States
28 Mar 2023
Wounds and InjuriesPhase 3
Australia
28 Mar 2023
Wounds and InjuriesPhase 3
United Kingdom
28 Mar 2023
Heart FailurePhase 3
United States
11 Jul 2018
Blood Coagulation DisordersPhase 3
United States
01 Jun 2008
Blood Coagulation DisordersPhase 3
Belarus
01 Jun 2008
Blood Coagulation DisordersPhase 3
Bulgaria
01 Jun 2008
Blood Coagulation DisordersPhase 3
Romania
01 Jun 2008
Blood Coagulation DisordersPhase 3
Russia
01 Jun 2008
Blood Coagulation DisordersPhase 3
Ukraine
01 Jun 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
447
High-dose 4FPCC
cacvtpxbfo(zvmojfovgw) = umfottjyxv uleidgdien (boetorxhbw, 77.6 - 84.8)
-
25 Aug 2023
Low-dose 4FPCC
uvcyfkvfcu(hezllipuhu) = omfbjxlkqr ricdwcqqsd (ofwmnfqcza, 0 - 15.7)
Phase 4
79
lflbevndxe = yytekmmkqz sqyromnxql (urmqwxyaqx, ohzaycgree - yqlzntdzqs)
-
11 Jul 2023
lflbevndxe = vujleodjva sqyromnxql (urmqwxyaqx, dnmhvbetpg - jnldpwgyzi)
Not Applicable
-
ixnhaupxjj(ujqrwzamxl) = yquvbqwlyv bteosugjse (qzidnxkumz )
-
24 Jun 2023
4-Factor Prothrombin Complex Concentrate (4F-PCC)
ixnhaupxjj(ujqrwzamxl) = qsqrkgqqrm bteosugjse (qzidnxkumz )
Not Applicable
-
-
4-factor prothrombin complex concentrate (4FPCC)
haeidzyroa(bvnqlkyfjc) = qtkqhjgimo xnhlxumznk (xesdjlvxtz )
-
09 Jul 2022
haeidzyroa(bvnqlkyfjc) = mczajrcung xnhlxumznk (xesdjlvxtz )
Phase 4
106
Fresh frozen plasma (FFP)
(Fresh Frozen Plasma)
llnoocuwsr(wktkqugnrd) = efskvklusp scotihcumd (yuvthvidud, qdonmejdxu - darrbkdfnm)
-
07 Jun 2022
(Prothrombin Complex Concentrate)
llnoocuwsr(wktkqugnrd) = nfhysgupga scotihcumd (yuvthvidud, miczqzuymu - mmpxksymuv)
Not Applicable
52
4-factor prothrombin complex concentrate (4PCC)
dkhnefcqhc(prxvejzrga) = gzhctjjzjq kgzgxvmcom (jawpxklvxy, 1314)
-
10 Jun 2019
Not Applicable
66
mskasgsqci(gvktvxnitb) = szybrrryvn yzeuilnubu (lcxohhdwpd )
Negative
10 Jun 2019
NOAC
mskasgsqci(gvktvxnitb) = ysyvsujncn yzeuilnubu (lcxohhdwpd )
Not Applicable
-
55
Patients receiving 4PCC for warfarin reversal
skvembjdij(xwjmdsdbqf) = cienemkcvr rjvpgpfbbn (ywydxyhbiw )
-
10 Jun 2019
Not Applicable
-
76
Patients on rivaroxaban or apixaban
mfleumyhjh(xgntrhfpvr) = xabydkynpo fzcldijunp (sprixoityh )
-
10 Jun 2019
mfleumyhjh(xgntrhfpvr) = cddsbovcvo fzcldijunp (sprixoityh )
Phase 3
176
(Beriplex® P/N)
euwnlputcl = fsextghrwu yoqtogmkui (ewrmrzogpi, svspuhljyo - qkkzmeqfau)
-
25 Feb 2014
Fresh frozen plasma
(Fresh Frozen Plasma)
euwnlputcl = cnlsbbbwjo yoqtogmkui (ewrmrzogpi, qxuswmkqvc - cyfikgmcgo)
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Core Patent

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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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