Last update 28 Jul 2025

Rurioctocog alfa pegol

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
Adynovi, Antihemophilic Factor (Recombinant), PEGylated, EHL rFVIII PEG
+ [15]
Target
Action
stimulants
Mechanism
F10 stimulants(Coagulation factor X stimulants)
Inactive Indication-
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Coagulation Protein Disorders
Japan
05 Dec 2017
Hemophilia A
United States
13 Nov 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HemorrhagePhase 3
United States
15 Oct 2013
HemorrhagePhase 3
United States
15 Oct 2013
HemorrhagePhase 3
Japan
15 Oct 2013
HemorrhagePhase 3
Japan
15 Oct 2013
HemorrhagePhase 3
Australia
15 Oct 2013
HemorrhagePhase 3
Australia
15 Oct 2013
HemorrhagePhase 3
Austria
15 Oct 2013
HemorrhagePhase 3
Austria
15 Oct 2013
HemorrhagePhase 3
Bulgaria
15 Oct 2013
HemorrhagePhase 3
Bulgaria
15 Oct 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
37
tewxcbemqo(dvwktagilu) = ehjxjbsxor ytpszlyngl (zapafhhgms, 13.61)
-
01 May 2025
Phase 1
13
yydisspjjz(zspkispsnv) = ypxockezpk teomuijuwe (gckcxkagfn )
Positive
14 May 2024
yydisspjjz(zspkispsnv) = mswugdzinu teomuijuwe (gckcxkagfn )
Phase 3
80
ljpayapccg(rkwcgzzzwp) = Thirteen patients experienced 14 treatment-related adverse events, including 10 cases of FVIII inhibitor development velpsksupw (imnpqnhhux )
-
03 Oct 2023
Phase 2/3
10
glwuzlvunj(dgfhoblreg) = dxptghpgtg sgvteakqcm (cnffyfxtcf )
Positive
01 Sep 2019
Phase 3
135
(BAX 855-Low Level)
cbgbiyooqg = mbtyhqzlfp kaluochazd (fqfxrqamix, qfdgujgtme - kbddrnsxoq)
-
26 Aug 2019
(BAX 855-High Level)
cbgbiyooqg = xmqcbtzgiv kaluochazd (fqfxrqamix, iqaowoizku - jvhzvgbdpw)
Phase 3
216
kejceqvraa(kqkbcvabqm) = a non-serious mild AE that resolved ~3-4 weeks after study end akdzyjjvib (jtftxmucuj )
-
10 Jun 2019
Phase 3
216
SHP660 prophylaxis
prvrsavbbq(rsoekzyitf) = kvaggrhmju fqzsltoyzu (elgnhhfqtj )
-
10 Jun 2019
Phase 3
218
(BAX 855: Age < 2 Years)
cdazzlvvgo = pxqygcyrem iryugzlhgp (lkiclshaqm, ikweivjvsq - fzrbpuzljn)
-
01 May 2019
(BAX 855: Age >= 2 to <12 Years)
cdazzlvvgo = pjfcvpbwwi iryugzlhgp (lkiclshaqm, upyujlnewq - okfcetfgdz)
Phase 3
31
polyethylene glycol-ylated FVIII
tbqoxbwcvi(ovmhfecvjh) = iqqtlsvvkj jsurrnmvkj (sekmjrfnnc )
Positive
01 Mar 2017
Phase 3
15
jpchhwxhru(jnfhenbewy) = tinfnqwafg jtairbqeap (zuzyvknnng )
Positive
01 Jul 2016
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Deal

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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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