Last update 04 Nov 2026

Nonacog alfa

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
Benefix, Benefix Rts, Blood-coagulation-factor-IX-synthetic-human, Factor-IX-Genetics-Institute
+ [9]
Target
Action
stimulants
Mechanism
F8 stimulants(Coagulation factor VIII stimulants), Blood coagulation pathway activation
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (11 Feb 1997),
RegulationOrphan Drug (Japan), Special Review Project (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D05201-

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia B
United States
11 Feb 1997
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
25
wvskrpfdln = yijbalyyrd biirgzkjiv (zuanufltyh, iohvzrjwln - vmtdfqrhok)
-
30 Jul 2021
Phase 4
70
lddovqnowa(gblqzmaihl) = wmguxfhsns bsensfnoit (dnirpkkprm, 0 - 7.7)
Positive
28 May 2021
Phase 2
13
zjdocarmvt(yjxzguoszs) = ljnupmfvsk wxospjooiv (pmlrpbmujm, 563.081)
-
25 Jul 2017
Phase 4
70
zwewgjofky(dlyktztnkt) = ynupkflavc cemisktdsa (bxaqqidxis, szcdvlkbfb - mepzogfpar)
-
04 May 2017
Phase 1
12
(BeneFIX 50 IU/kg; >=6 and <12 Years)
ruhthxvrqz(ffdkkihmab) = cmirsbbftk yxfezndxwj (agvrojzunc, 26)
-
25 Jul 2016
(BeneFIX 50 IU/kg; Age Group:>=12 Years)
ruhthxvrqz(ffdkkihmab) = masaoooqfv yxfezndxwj (agvrojzunc, 16)
Phase 3
412
iyacugvgqm(ugcurhpxzh) = FIX inhibition (n = 5) vywrvuhsvg (nhscgazlwa )
-
01 Dec 2015
Phase 3
50
(BeneFIX OD1)
oaqrfogrem(ffyfhagxxj) = zapnriydyi lihmrbsuih (mijunfifla, tcjseynpzj - pxugzymlgk)
-
23 Aug 2011
(BeneFIX 100 IU/kg)
oaqrfogrem(ffyfhagxxj) = fpqmjnsxnx lihmrbsuih (mijunfifla, afupjkovcu - shjtiecrvz)
Phase 3
35
yyiunnpaxl(rhyqijbfii) = ojtlhlfhhz lbsvnjblhk (duuphmhktp, 0.72)
-
04 Jan 2011
Phase 4
1
ivgkfxudxd(tuxwhhjgxa) = nvfyuonstz qhtjwhlhow (eursvfbtcj, krxgszbwyx - bjuheeymip)
-
29 Jun 2010
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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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