CDEK
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fibrinogen (human)

Trade name: RiaSTAP

BiologicalapprovedOrphan Drug FDA

Approved

Mar 21, 2003

Clinical trial activity

78 trials · 88 clinical orgs · 6 marketing orgs

Phase 1
8
Phase 2
46
Phase 3
27
Phase 4
20

Earliest trial started Dec 1, 2000 (NCT00512356)

Timeline

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Mar 21, 2003

    Earliest FDA Approval

  3. Mar 21, 2003

    Omrix Biopharmaceuticals, Inc. — NDA Secondary Org

  4. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

  5. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

  6. Mar 13, 2008

    Orphan Drug Designation

  7. Mar 19, 2008

    Baxter — NDA Secondary Org

  8. Jan 20, 2009

    CSL Behring — First NDA Organization

  9. Jan 20, 2009

    CSL Behring — NDA Organization

2010s

  1. Apr 30, 2015

    International Minerals and Chemical Corporation — NDA Secondary Org

  2. Jun 7, 2017

    Octapharma — NDA Secondary Org

  3. Nov 1, 2017

    Grifols — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMar 21, 2003

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • beriplast p
  • coagulation factor i
  • factor i (fibrinogen)
  • factor i human
  • fibrinogen
  • fibrinogen
  • fibrinogen
  • fibrinogen concentrate human
  • fibrinogen concentrate (human)
  • fibrinogen concentrate (human)
  • fibrinogen concentrate (human)
  • fibrinogen human
  • fibrinogen (human)
  • fibrinogen, human
  • fibrinogen, human
  • fibrinogen human plasma-derived
  • fibrogen
  • human fibrinogen
  • human fibrinogen
  • riastap
  • riastap

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07265843Phase 4Jan 1, 2026Trauma Hemostatis and Oxygenation Research (THOR) Network
NCT06764927Phase 4Oct 31, 2025University of Pittsburgh
NCT06582420N/AJan 1, 2025Unidade Local de Saude do Arco Ribeirinho
NCT06664775Phase 3Nov 25, 2024Corza Medical GmbH
NCT06617897Phase 3Sep 30, 2024CSL Behring
NCT06124209Phase 4Nov 4, 2023Medical University of Warsaw
NCT05780125Phase 2Mar 20, 2023University of Milan
NCT05449834Phase 3Oct 1, 2022Australasian College for Emergency Medicine, Australasian Trauma Society, Australian and New Zealand Intensive Care Society Clinical Trials Group, Australian Red Cross, Monash University
NCT05385952N/AAug 4, 2022GATT Technologies BV, Radboud University, Rutgers University
NCT05391412Phase 4May 23, 2022Masaryk University, University Hospital Brno
NCT05300672Phase 3Feb 8, 2022Government of Italy, University of Bologna
NCT05091684Phase 2Nov 1, 2021Institut de Cancérologie de la Loire (ICLN), Institut de Cancérologie Lucien Neuwirth
NCT04534751Phase 4Apr 1, 2021Canadian Institutes of Health Research (CIHR), Government of Canada, Octapharma, University of Toronto
NCT04660721Phase 1/Phase 2 (Phase 2)Dec 31, 2020Sealantium Medical Ltd.
NCT04636268Phase 3Nov 30, 2020Grifols
NCT04602689N/AOct 30, 2020Seoul National University, University of Ulsan, Yonsei University
NCT04376762Phase 4Sep 1, 2020Octapharma, University of Virginia
NCT04065880N/AApr 1, 2020University of Basel
NCT04434001Phase 2Feb 27, 2020University of Milan
NCT03932240Phase 3Jul 31, 2019Emory University
Showing 20 of 78 trials
Page 1 / 4

Organizations

Research & Development (88)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
CSL BehringFor profit13532007
OctapharmaFor profit5332013
NycomedFor profit4422004
University of Sao PauloAcademic/Hospital4332009
Australian Red CrossAcademic/Hospital3022016
Emory UniversityAcademic/Hospital3232011
GrifolsFor profit3322016
Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaAcademic/Hospital3222018
University of MilanAcademic/Hospital3322011
University of TorontoAcademic/Hospital3332014
Biotest PharmaceuticalsFor profit2212013
Emergency Medicine FoundationAcademic/Hospital2012016
Government of CanadaGovernment2122014
Griffith UniversityAcademic/Hospital2212016
Laboratoire français de Fractionnement et de BiotechnologiesFor profit2222014
Medical University InnsbruckAcademic/Hospital2222011
University of BarcelonaAcademic/Hospital2222012
University of CopenhagenAcademic/Hospital2222011
University of GothenburgAcademic/Hospital2212009
University of UlsanAcademic/Hospital2122017
88 organizations
Page 1 / 5

Marketing (6)

OrganizationOrg typeRelationshipDate
BaxterFor profitNDA2Mar 19, 2008
CSL BehringFor profitNDAJan 20, 2009
GrifolsFor profitNDA2Nov 1, 2017
International Minerals and Chemical CorporationFor profitNDA2Apr 30, 2015
OctapharmaFor profitNDA2Jun 7, 2017
Omrix Biopharmaceuticals, Inc.For profitNDA2Mar 21, 2003