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antihemophilic factor viii (Recombinant)

Trade name: Adynovate

Recombinant proteinapprovedOrphan Drug FDA

Approved

Dec 10, 1992

Factor VIII, an essential blood coagulation protein, is used as a medication to treat and prevent bleeding in people with hemophilia A and other causes of low factor VIII. Certain preparations may also be used in those with von Willebrand's disease. It is given by slow injection into a vein. — Wikipedia

Clinical trial activity

74 trials · 51 clinical orgs · 5 marketing orgs

Phase 1
14
Phase 2
31
Phase 3
35
Phase 4
22

Earliest trial started Feb 1, 2001 (NCT00157105)

Timeline

1980s

  1. Sep 25, 1989

    Orphan Drug Designation

1990s

  1. Dec 10, 1992

    Takeda — Earliest FDA Approval

  2. Dec 10, 1992

    Takeda — NDA Secondary Org

  3. Dec 10, 1992

    Takeda — NDA Organization

2000s

  1. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  2. Jun 27, 2001

    American Home Products — NDA Secondary Org

  3. Aug 20, 2002

    Bayer — NDA Secondary Org

  4. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  5. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Oct 15, 2013

    Novo Nordisk — NDA Secondary Org

  2. Sep 4, 2015

    Octapharma — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 10, 1992

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Multi-specific
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • advate
  • advate
  • adynovate
  • adynovate
  • adynovate
  • antihemophilic factor, human (monoclonal)
  • antihemophilic factor, human recombinant
  • antihemophilic factor recombinant
  • antihemophilic factor (recombinant)
  • antihemophilic factor (recombinant)
  • antihemophilic factor,recombinant
  • antihemophilic factor, recombinant
  • antihemophilic factor (recombinant), pegylated
  • antihemophilic factor (recombinant), pegylated
  • antihemophilic factor (recombinant), plasma/albumin-free method
  • antihemophilic factor (recombinant), rahf
  • bax 855
  • bay 14-2222
  • bay-14-2222
  • bay14-2222
  • bay14-2222
  • bay 81-8973
  • bay94-9027
  • bebulin
  • bebulin
  • factor viii (rdna)
  • factor viii recombin
  • factor viii (recombinant)
  • factor viii, recombinant
  • greengene f
  • human coagulation factor viii / human von willebrand factor
  • human factor viii recombinant
  • human factor viii (recombinant)
  • iblias
  • monoclate
  • monoclate-p
  • monoelate-p
  • nuwiq
  • octocog alfa
  • octocog alfa
  • octocog alfa
  • octocog alfa
  • octocog alfa
  • octocog alfa
  • octocog alfa
  • pegylated recombinant factor viii
  • rahf
  • recombinant antihemophilic factor
  • recombinant antihemophilic factor viii
  • recombinant coagulation factor
  • recombinate
  • recombinate
  • recombinate
  • sct800

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07129343Phase 3Oct 12, 2025Takeda
NCT06738901Phase 3Mar 31, 2025SK Plasma Co., Ltd.
NCT06864975Phase 4Mar 1, 2025Capital Medical University
NCT06205095Phase 3Jun 30, 2024Unity Health Toronto
NCT05935358Phase 4Oct 31, 2023Octapharma
NCT05936580Phase 4Oct 31, 2023Octapharma, University of Bonn
NCT05707351Phase 3Mar 27, 2023Takeda
NCT05582993Phase 3Jan 9, 2023Takeda
NCT05728528Phase 4Jul 1, 2022Chulalongkorn University
NCT05251090Phase 1Apr 30, 2022Capital Medical University, Jiangsu Gensciences lnc.
NCT05147662Phase 3Feb 28, 2022Bayer
NCT04985682Phase 4Dec 30, 2021Shire, Takeda
NCT05042440Phase 1Aug 11, 2021Sanofi
NCT04864743Phase 1Jun 22, 2021Chinese Academy of Medical Sciences, Jiangsu Gensciences lnc.
NCT04690322Phase 4Apr 15, 2021The University of Texas, Dallas
NCT04534751Phase 4Apr 1, 2021Canadian Institutes of Health Research (CIHR), Government of Canada, Octapharma, University of Toronto
NCT04784988Phase 4Mar 1, 2021University of Naples Frederico II
NCT04565236Phase 4Sep 22, 2020Bayer
NCT04621916Phase 4Sep 21, 2020Children's Hospital Los Angeles, Grifols
NCT03947320Phase 3Dec 20, 2019Sinocelltech Ltd.
Showing 20 of 74 trials
Page 1 / 4

Organizations

Research & Development (51)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BaxaltaFor profit242242001
BayerFor profit8832010
Sinocelltech Ltd.For profit5532016
Bioverativ Therapeutics Inc.For profit4332010
OctapharmaFor profit4322019
TakedaFor profit4322021
Green Cross CorporationFor profit3312004
University of TorontoAcademic/Hospital3122002
Atlantic Research GroupAcademic/Hospital2012013
Capital Medical UniversityAcademic/Hospital2122022
Central South UniversityAcademic/Hospital2022016
Chinese Academy of Medical SciencesAcademic/Hospital2022019
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,LtdFor profit2222019
Jiangsu Gensciences lnc.For profit2212021
PfizerFor profit2222005
SanofiFor profit2122018
ShireFor profit2222019
Swedish Orphan BiovitrumFor profit2122010
University of Texas at HoustonAcademic/Hospital2122006
BiogenFor profit1012010
51 organizations
Page 1 / 3

Marketing (6)

OrganizationOrg typeRelationshipDate
American Home ProductsFor profitNDA2Jun 27, 2001
BayerFor profitNDA2Aug 20, 2002
Novo NordiskFor profitNDA2Oct 15, 2013
OctapharmaFor profitNDA2Sep 4, 2015
TakedaFor profitNDA2Dec 10, 1992
TakedaFor profitNDADec 10, 1992