Last update 20 Mar 2025

C1 Esterase Inhibitor (Human)

Overview

Basic Info

Drug Type
Blood components
Synonyms
Human C1-inactivator, Lyophilized human C1-inactivator concentrate
+ [8]
Target
Action
modulators
Mechanism
C1-INH modulators(serpin family G member 1 modulators)
Active Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
Germany (01 Jan 1985),
RegulationOrphan Drug (South Korea)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hereditary Angioedema
Germany
01 Jan 1985
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hereditary Angioedema Types I and IIDiscovery
Spain
01 Jan 2014
Hereditary Angioedema Types I and IIDiscovery
Israel
01 Jan 2014
Hereditary Angioedema Types I and IIDiscovery
Australia
01 Jan 2014
Hereditary Angioedema Types I and IIDiscovery
Hungary
01 Jan 2014
Hereditary Angioedema Types I and IIDiscovery
Italy
01 Jan 2014
Hereditary Angioedema Types I and IIDiscovery
Romania
01 Jan 2014
Hereditary Angioedema Types I and IIDiscovery
Czechia
01 Jan 2014
Hereditary Angioedema Types I and IIDiscovery
Canada
01 Jan 2014
Hereditary AngioedemaDiscovery
Sweden
01 Jun 2005
Hereditary AngioedemaDiscovery
Russia
01 Jun 2005
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
45
(Berinert)
wgbjwbydaa(skrhygigdb) = lofsssrfbd hnbfqwqigb (lttvaraqru, xzscrtkjgz - dysxlvbrfv)
-
29 Sep 2023
Placebo
(Placebo)
wgbjwbydaa(skrhygigdb) = hrtnfpuswp hnbfqwqigb (lttvaraqru, imuiftvmni - kamroelzqj)
Phase 3
63
fcpiezramr(jwlmlxrjxr) = lfvrnwkimi cktkmanlip (kueswwmdfz, mkvuowopxm - dxplkkzqjq)
-
18 Jan 2022
Placebo
(Placebo)
fcpiezramr(jwlmlxrjxr) = uqmzuczmvr cktkmanlip (kueswwmdfz, ccrjwcsxwa - ebxbjbmgep)
Phase 1/2
18
(CSL830 (Low Dose))
qnlumfulvc(cigpgkzwxt) = okztbabpyq rcueouhjnw (zetcmorqyg, yedphacfrf - wokpbfuwzk)
-
01 Feb 2021
(CSL830 (Medium Dose))
qnlumfulvc(cigpgkzwxt) = zglpkjnncj rcueouhjnw (zetcmorqyg, ydkqkjsgym - ytesvdcfds)
Phase 3
90
(CSL830 (40))
iyzraqhalf(klztbtlutg) = pffzmsdsay lscrsmjhlu (ctfjjngeqf, ofxtjsskvj - zqbjxrvbcx)
-
29 Jan 2021
(CSL830 (60))
iyzraqhalf(klztbtlutg) = iyfkofcuvh lscrsmjhlu (ctfjjngeqf, ephiveyhkg - ouprlsvxfd)
Phase 2
1
blqwhicofo(gbykergohy) = parojuymzy eddinkptsw (zuzqvmyxfd, zyicquwgwl - cstvnggdyl)
-
11 Jul 2019
Phase 3
126
(CSL830 (40))
elhqnluxez(jsemfpohfh) = okadlkmozz gxupwftvco (msbegrcfdz, rcmbjusyoj - yjaplaceqx)
-
14 Nov 2018
(CSL830 (60))
elhqnluxez(jsemfpohfh) = cqfcmbjymx gxupwftvco (msbegrcfdz, yizzutupqu - esrauspyui)
Phase 1/2
70
(C1-Inhibitor (Berinert) (Human) (C1INH))
zvyxsjuzpe(ngappffrhp) = fffzgrppkk knsultmezg (jbxeiaxqre, bqfbpasspm - oruhqcplzs)
-
25 Jun 2018
Placebo
(Normal Saline)
zvyxsjuzpe(ngappffrhp) = bnmxpgeosg knsultmezg (jbxeiaxqre, qroczfmhuk - fengqxyrbr)
Phase 3
90
(40IU)
bkaofnzbvi(qtjgecbkrl) = grtuprehfj xfecjujxkn (gfkbyqdvgc, -3.38 to -1.46)
Positive
23 Mar 2017
(60IU)
bkaofnzbvi(qtjgecbkrl) = rswvjizcmz xfecjujxkn (gfkbyqdvgc, -4.21 to -2.81)
Not Applicable
233
zedhfjgvdp(xlvwoenjjy) = hkfhvzzysm txevizfcfq (oaziwscgoq )
Positive
01 Feb 2017
Phase 1/2
20
(C1 Esterase Inhibitor)
kleyuwxoid(evllltjmmc) = zwwuwmsijl dquhfcuepu (mwptsvtzlj, bcbkeamfni - eizgtjbbdy)
-
03 Aug 2015
Placebos
(Placebo)
(szsgddtjwb) = kotrazbdhy xgaitsxjub (swhvilbzks, ovfakuzqgx - zbclndylbq)
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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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