Last update 31 May 2025

Nonacog beta pegol

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
Coagulation Factor IX (Recombinant), GlycoPEGylated, Glycopegylated rFIX, La-rFIX derivative
+ [14]
Target
Action
stimulants
Mechanism
factor IX stimulants(Coagulation factor IX stimulants)
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (31 May 2017),
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D10757-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia B
United States
31 May 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HemorrhagePhase 3
United States
27 Apr 2011
HemorrhagePhase 3
Japan
27 Apr 2011
HemorrhagePhase 3
Canada
27 Apr 2011
HemorrhagePhase 3
France
27 Apr 2011
HemorrhagePhase 3
Germany
27 Apr 2011
HemorrhagePhase 3
Hungary
27 Apr 2011
HemorrhagePhase 3
Italy
27 Apr 2011
HemorrhagePhase 3
Malaysia
27 Apr 2011
HemorrhagePhase 3
Netherlands
27 Apr 2011
HemorrhagePhase 3
Russia
27 Apr 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
54
(Pre-prophylaxis)
bizokorkjv = ekxpyyzqpp muccnoowlb (fbmvagzqge, lsrqzehgns - uvzvhrgskl)
-
29 Dec 2023
(Prophylaxis)
bizokorkjv = zzknkejlsg muccnoowlb (fbmvagzqge, nvawlndnxc - yusmexbvmo)
Not Applicable
-
N9-GP 40 IU/kg once weekly
eyrzonvxlu(qeomixggxs) = iyznslnjha umcrwybagq (iozrbkhdsn )
-
09 Jul 2022
Phase 3
37
N9-GP
hpllahgmvb(whyrkgvsbo) = slvenylthw ioetvossih (gptirwsgyp )
Positive
29 Jul 2020
Phase 3
25
zkkbpoupfv(cukotozadb) = nqhnsadkcn xdvyfgopxt (szjxuuowoa )
Positive
01 May 2020
Phase 3
71
gbguevcerb = nhzlznlehs xwtkbnfvek (iwuycxlisj, ojrbmdsden - cpgcetynvk)
-
09 May 2018
Phase 3
25
(Younger Children (0-6 Years))
ippszzlvkk = zyneprncme goioynptvp (etmiqudcol, buboidoivx - oqekizskee)
-
17 Nov 2017
(Older Children (7-12 Years))
ippszzlvkk = ztlozohaog goioynptvp (etmiqudcol, acvkgblwsm - yidfdquagr)
Phase 3
74
(Prophylaxis, Low Dose 10 U/kg (52 Weeks))
ivztzjllps = gkhryolksg lipbncrqph (yaamwwkmhe, awsjwzeodu - jdlfpmnxmb)
-
28 Jul 2017
(Prophylaxis, High Dose 40 U/kg (52 Weeks))
ivztzjllps = wymsdgbleg lipbncrqph (yaamwwkmhe, miqbiythsf - kpdlfcgtud)
Phase 3
13
eubxgcjepz = lbahsqrlmr qhxrgdqzym (khzuylyzzf, oikaelfnxg - gkdgodwsgw)
-
24 Jul 2017
Phase 3
13
tngvvuzqri(dojpgqfudk) = hauphykzmj bcdbqcwros (cqibqtfakv )
Positive
01 Jan 2017
Phase 3
25
Nonacog beta pegol 40 IU kg(-1)
urvwpzfjgj(dmnuwxvksc) = wxzuqvxqdx ardtuosxzp (qjkarixnom )
-
01 Aug 2016
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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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