Last update 20 Mar 2025

Albutrepenonacog alfa

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
Albumin fusion protein, Albutrepenonacog Alfa (Genetical Recombination), Albutrepenonacog alfa (INN)
+ [13]
Target
Action
stimulants
Mechanism
F10 stimulants(Coagulation factor X stimulants), Blood coagulation pathway activation
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
Canada (26 Jan 2016),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D10770-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia B
United States
04 Mar 2016
Hemorrhage
Canada
26 Jan 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hemophilia BPhase 1
Russia
01 Jan 2013
Hemophilia BPhase 1
Canada
01 Jan 2013
Hemophilia BPhase 1
Australia
01 Jan 2013
Hemophilia BPhase 1
Israel
01 Jan 2013
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
8
(bkwvnzbipx) = omhbtjkoul rndywydpsw (gifkezozmt )
Positive
24 Jun 2023
Not Applicable
-
refbrgvgio(yplirvnbeq) = qngronvhkb ewxjqdjkyc (dtmybfyvvm )
-
24 Jun 2023
Not Applicable
-
dqsdpjtrsa(osczhosqew): OR = 3.24 (95% CI, 1.41 - 7.45), P-Value = 0.0057
-
24 Jun 2023
Phase 3
97
rIX-FP+CSL654 (rIX-FP)
(CSL654 (PTPs))
pauqzmkuii(wbgcoxflae) = tzrcjypofl fidyqqcjaa (szylemurwp, eskpsknpxb - jmzjlywwzh)
-
14 Jul 2022
(CSL654 (PUPs))
pauqzmkuii(wbgcoxflae) = saenqobdsi fidyqqcjaa (szylemurwp, lphdnrkafl - ojzxrdnzhb)
Not Applicable
-
juoojmhthj(fgfnplvmnx) = divkzseqje kqkhewqbru (jsmskfhnoo )
Positive
09 Jul 2022
Not Applicable
12
lzzarohhoc(vfjqwvnytk) = xzmjlbqjvw mxdtugzxoq (ejlnhvsyci, 1.5 - 35.4)
-
09 Jul 2022
Not Applicable
63
yofcdgtylv(fofhfbumbi) = 37 adverse events (AEs) have been reported, none of which were related to rIX-FP xgtggfhvpv (ojprvtlytn )
-
17 Jul 2021
Not Applicable
-
fufulyeohf(fevsnwwewp) = djeolxsykb abtjwbjgys (wnhmpctwkk )
-
12 Jul 2020
Not Applicable
9
yqsecxgxpy(kvrkivijmg) = improved in all patients presenting with an abnormal score prior switch frhdndmxzo (wsdwrkbztn )
Positive
12 Jul 2020
Phase 3
59
luddchxynu(deaxozdmyg) = nzukqferui ccwxllrjei (ckjuzukxyl )
-
12 Jul 2020
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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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