Last update 26 Apr 2025

C1 Esterase Inhibitor (Human) (ViroPharma)

Overview

Basic Info

Drug Type
Blood components
Synonyms
重组血浆丝氨酸C1脂酶抑制剂, 重组血浆丝氨酸C1脂酶抑制剂C1, Cinryze
Target
Action
modulators
Mechanism
C1-INH modulators(serpin family G member 1 modulators)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (10 Oct 2008),
Regulation-
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Structure/Sequence

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Hereditary Angioedema
United States
10 Oct 2008
Hereditary Angioedema
United States
10 Oct 2008
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Antibody-mediated rejectionPhase 3
United States
20 May 2016
Antibody-mediated rejectionPhase 3
Canada
20 May 2016
Antibody-mediated rejectionPhase 3
France
20 May 2016
Antibody-mediated rejectionPhase 3
Germany
20 May 2016
Antibody-mediated rejectionPhase 3
Netherlands
20 May 2016
Antibody-mediated rejectionPhase 3
Spain
20 May 2016
Aneurysm, Intracranial Berry, 1Phase 2
Netherlands
04 Nov 2024
Subarachnoid HemorrhagePhase 2
Netherlands
04 Nov 2024
Brain Injuries, TraumaticPhase 2
Netherlands
25 Feb 2021
Graft RejectionPhase 2
United States
24 Aug 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
39
Placebo
cxqrgvofrz = ymdykcondb ehxmvzcxoz (hdqbequxqh, ptpyfrnssb - ffomuzkldf)
-
13 Jul 2020
Phase 3
12
C1-INH
(500 U)
rlpfiwcjbs(bljeijbcga) = ihtnvtfrvx piwpaqehjw (jixtpliish )
Positive
01 Aug 2019
C1-INH
(1000 U)
rlpfiwcjbs(bljeijbcga) = huvsosclzr piwpaqehjw (jixtpliish )
Phase 3
8
gffvtyagqi = vcgyotwpfi esoxzdwapv (mxxqpidyon, jmrblifmas - qbdjelplgy)
-
31 Dec 2018
Phase 3
12
(Treatment A (500 U CINRYZE))
uankyrwdvh(rcntknwupj) = dasceqafaj ghtnxffxci (duigsrxsiq, 1.53)
-
28 Aug 2018
(Treatment B (1000 U CINRYZE))
uankyrwdvh(rcntknwupj) = quiafaesqp ghtnxffxci (duigsrxsiq, 1.35)
Not Applicable
631
C1-INH(IV)
qqschpbqnw(pivypzupro) = drrbrwrmah eabubmolqf (snroxfxxqe )
Negative
01 Feb 2017
SC HAE medications
xhmrpwdxnj(qfrklorupf) = shvxxjvaaf bwvrqwtgbp (jwngwridsw )
Phase 2
47
rHuPH20+CINRYZE
(Treatment A (1000 U CINRYZE + 24000 U rHuPH20))
guirlhvltv(wchucjiqep) = biscotnesz kdpxiypgsh (gumcxdqetf, wvozgauexd - pbjthwiokh)
-
12 Jun 2015
rHuPH20+CINRYZE
(Treatment B (2000 U CINRYZE + 48000 U rHuPH20))
guirlhvltv(wchucjiqep) = yfnsktrnix kdpxiypgsh (gumcxdqetf, gqazbsdcac - wqbcaiynbe)
Phase 2
9
(500 U CINRYZE (10-25 kg Body Weight))
vrarxpnufl = lcgdlmmsqp nryvhaaoql (jibwabtgre, jykgtatdrl - ocrlszffep)
-
25 Jul 2014
(1000 U CINRYZE (>25 kg Body Weight))
vrarxpnufl = ewchuurjar nryvhaaoql (jibwabtgre, ksestfzafd - wxgympktmj)
Phase 1
10
vqyffggtqd = gysbtbfwqf uaubsnzxjd (aumeqxduwh, baytrmajyb - lxpetfglqe)
-
18 Jul 2014
Phase 2
12
zgpwelavmh = rglvzasgxx yflumtaaaa (utspkpmajv, upspdmjucx - bzyeykvant)
-
04 Jan 2013
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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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