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C1 Esterase Inhibitor (Human)

Trade name: Cinryze

Recombinant proteinapprovedOrphan Drug FDA

Approved

Oct 10, 2008

C1-inhibitor is a protease inhibitor belonging to the serpin superfamily. Its main function is the inhibition of the complement system to prevent spontaneous activation but also as the major regulator of the contact system. — Wikipedia

Clinical trial activity

58 trials · 33 clinical orgs · 3 marketing orgs

Phase 1
11
Phase 2
40
Phase 3
24
Phase 4
5

Earliest trial started Jun 1, 2003 (NCT00261053)

Timeline

1990s

  1. Oct 16, 1992

    Orphan Drug Designation

2000s

  1. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  4. Oct 10, 2008

    Lev Pharmaceuticals — Earliest FDA Approval

  5. Oct 10, 2008

    Lev Pharmaceuticals — NDA Organization

  6. Oct 10, 2008

    Takeda — NDA Secondary Org

  7. Oct 9, 2009

    CSL Behring — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedOct 10, 2008

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • berinert
  • c-1-esterase
  • c1 esterase inhibitor
  • c1-esterase inhibitor
  • c1 esterase inhibitor (human)
  • c1 esterase inhibitor (human)
  • c1-esterase inhibitor, human
  • c1-inhibiting factor
  • c1 inhibitor
  • c1 inhibitor human
  • c1 inhibitor (human)
  • c1 inhibitor (human)
  • c1 inhibitor, human
  • c1-inhibitor, plasma derived
  • c1in protein, human
  • c1nh protein, human
  • c1s inhibitor, human
  • c1s-inh protein, human
  • cinryze
  • cinryze
  • cinryze
  • complement c1 inhibitor, human
  • complement c1s inhibitor, human
  • human c1-esterase inhibitor
  • human c1 inhibitor
  • human c1 inhibitor
  • plasma protease c1 inhibitor
  • plasma protease c1 inhibitor, human
  • recombinant c1 inhibitor
  • rhc1inh
  • serine (or cysteine) proteinase inhibitor, clade g (c1 inhibitor), human
  • serping1 protein, human

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06919003Phase 2Sep 22, 2025Cedars-Sinai Medical Center, National Institute of Allergy and Infectious Diseases (NIAID)
NCT06359782Phase 2May 1, 2024Leiden University, Medical Center Haaglanden, Takeda
NCT06361537Phase 3Apr 30, 2024Octapharma
NCT04898309Phase 2/Phase 3 (Phase 3)Dec 1, 2021AO GENERIUM
NCT04696146Phase 1/Phase 2 (Phase 2)Mar 3, 2021Cedars-Sinai Medical Center, OneLegacy Foundation
NCT05010876Phase 2Feb 4, 2021GCS Ramsay Santé pour l’Enseignement et la Recherche, University of Montpellier
NCT04489160Phase 2Aug 31, 2020Leiden University, Netherlands Brain Foundation, Takeda
NCT03791476Phase 1Jun 21, 2019Pharming Group, University of Wisconsin
NCT03576469Phase 4Jun 13, 2018IMMUNOe
NCT03221842Phase 3Nov 6, 2017CSL Behring
NCT02435732Phase 1May 1, 2017Shire, University of Wisconsin
NCT03051698Phase 4Nov 16, 2016Sanquin, University of Amsterdam, ZonMw: The Netherlands Organisation for Health Research and Development
NCT02936479Phase 2Oct 1, 2016CSL Behring, New York University
NCT02865720Phase 3Sep 1, 2016Shire
NCT02663687Phase 1Apr 1, 2016Shire
NCT02584959Phase 3Jan 1, 2016Shire
NCT02547220Phase 3Oct 1, 2015Shire
NCT02316353Phase 3Dec 1, 2014CSL Behring
NCT02247739Phase 2Dec 1, 2014Pharming Group
NCT02251041Phase 2Sep 1, 2014Katholieke Universiteit Leuven
Showing 20 of 58 trials
Page 1 / 3

Organizations

Research & Development (33)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ShireFor profit171642005
CSL BehringFor profit11842005
Pharming GroupFor profit10932003
SanquinAcademic/Hospital6332005
University of California, San DiegoAcademic/Hospital5022005
ViroPharmaFor profit5032009
Cedars-Sinai Medical CenterAcademic/Hospital4312011
University of AmsterdamAcademic/Hospital4132005
University of WisconsinAcademic/Hospital3222010
Halozyme TherapeuticsFor profit2012011
Katholieke Universiteit LeuvenAcademic/Hospital2222013
Leiden UniversityAcademic/Hospital2112020
Radboud UniversityAcademic/Hospital2222008
TakedaFor profit2012020
Utrecht UniversityAcademic/Hospital2112012
AO GENERIUMFor profit1112021
GCS Ramsay Santé pour l’Enseignement et la RechercheAcademic/Hospital1112021
IMMUNOeAcademic/Hospital1112018
Johns Hopkins UniversityAcademic/Hospital1112013
J. W. Goethe UniversityAcademic/Hospital1112008
33 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
CSL BehringFor profitNDA2Oct 9, 2009
Lev PharmaceuticalsFor profitNDAOct 10, 2008
TakedaFor profitNDA2Oct 10, 2008