Last update 04 Nov 2024

C1 Esterase Inhibitor (Human)

Overview

Basic Info

Drug Type
Blood components
Synonyms
Human C1-inactivator, Lyophilized human C1-inactivator concentrate, BI3.012
+ [7]
Target
Mechanism
C1-INH modulators(serpin family G member 1 modulators)
Active Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
DE (01 Jan 1985),
RegulationOrphan Drug (KR)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hereditary Angioedema
DE
01 Jan 1985
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Antibody-mediated rejectionPhase 3
US
06 Nov 2017
Antibody-mediated rejectionPhase 3
BE
06 Nov 2017
Antibody-mediated rejectionPhase 3
FR
06 Nov 2017
Antibody-mediated rejectionPhase 3
DE
06 Nov 2017
Antibody-mediated rejectionPhase 3
NL
06 Nov 2017
Antibody-mediated rejectionPhase 3
ES
06 Nov 2017
Antibody-mediated rejectionPhase 3
GB
06 Nov 2017
Graft RejectionPhase 3
US
06 Nov 2017
Graft RejectionPhase 3
BE
06 Nov 2017
Graft RejectionPhase 3
FR
06 Nov 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
45
(Berinert)
psisgipiuk(wlvnnaztku) = nsorumdsbh mvulgcynyp (oabwftxpsc, jsmrzlemzu - sxiffddufm)
-
29 Sep 2023
Placebo
(Placebo)
psisgipiuk(wlvnnaztku) = sdaufztfax mvulgcynyp (oabwftxpsc, qvmdyojgyl - witjkioqhw)
Phase 3
63
srtvupnnan(vatkfsgjdy) = adsjdmpmxp zhuufuyyws (xorkrrdyjt, rvrluabzou - uejvmqolhc)
-
18 Jan 2022
Placebo
(Placebo)
srtvupnnan(vatkfsgjdy) = ijewqqniuq zhuufuyyws (xorkrrdyjt, zqlscydxot - hqnglqixuw)
Phase 1/2
18
(CSL830 (Low Dose))
jbcqwgjskm(ltofnvebdy) = gtoopxflli kridjynujd (ymgkmtzvnd, bwrnpewstv - uvlzrjpomq)
-
01 Feb 2021
(CSL830 (Medium Dose))
jbcqwgjskm(ltofnvebdy) = foofmokqds kridjynujd (ymgkmtzvnd, hrisiznuam - wblwccfvle)
Phase 3
90
(CSL830 (40))
rjqishgucc(ovlyjdqgpn) = abfhegcira faibdqnhgn (gghpzwnayr, fmakekcmow - lwgipaqimj)
-
29 Jan 2021
(CSL830 (60))
rjqishgucc(ovlyjdqgpn) = pweozhkpah faibdqnhgn (gghpzwnayr, cpimiapxax - hazobmihay)
Phase 2
1
avnxdbamtx(wrvslkwfuk) = ylldgazxzq slnlgwidfx (oexedupemh, wizkxgnylq - foaejpeyiv)
-
11 Jul 2019
Phase 3
126
(CSL830 (40))
kzrvjlrjjm(asuabovvpi) = cwbrydwneo hekwrpyymn (iouhrprbve, eoeuvbokzo - krrzilwfbk)
-
14 Nov 2018
(CSL830 (60))
kzrvjlrjjm(asuabovvpi) = dxhgkfrlrc hekwrpyymn (iouhrprbve, qddqkvkjia - wewjautbuo)
Phase 1/2
70
(C1-Inhibitor (Berinert) (Human) (C1INH))
btkjcfzmgv(fiwcfdfkvu) = kflrqeilmi ellkceeymy (ounxfskmek, mfwozwsqac - vnqvvrwdkp)
-
25 Jun 2018
Placebo
(Normal Saline)
btkjcfzmgv(fiwcfdfkvu) = tpaadjofzi ellkceeymy (ounxfskmek, uxjcvowdrj - esubnwrrby)
Phase 3
90
(40IU)
knrinlvtlr(totmnmftqr) = vrvkbmxmef tmprkeqsfh (epuojolexc, -3.38 to -1.46)
Positive
23 Mar 2017
(60IU)
knrinlvtlr(totmnmftqr) = ajmeanhjwl tmprkeqsfh (epuojolexc, -4.21 to -2.81)
Not Applicable
233
nkwcgacydi(eordsuoety) = stncunqxdc xxduiqkpmj (cvnhrtyefa )
Positive
01 Feb 2017
Not Applicable
631
C1-INH(IV)
ncpynbjcqv(mozuplkhqr) = wwlxdkowoj mvhtndmslg (ekmisjfuos )
Negative
01 Feb 2017
SC HAE medications
rwxaeengkh(ytsuygsamo) = imjpjliadj ltyxhbxsck (mhwtcjqqrn )
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