Last update 08 May 2025

Conestat alfa

Overview

Basic Info

Drug Type
Recombinant protein
Synonyms
C1 Esterase Inhibitor (Recombinant), C1 Inhibitor (Recombinant), Complement C1 esterase inhibitor
+ [12]
Action
inhibitors, modulators
Mechanism
C1S inhibitors(Complement C1s inhibitors), Kallikreins modulators(Kallikreins modulators), Mannan-binding lectin serine proteases inhibitors
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (28 Oct 2010),
RegulationOverseas New Drugs Urgently Needed in Clinical Settings (China), Orphan Drug (European Union)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hereditary Angioedema
Liechtenstein
28 Oct 2010
Hereditary Angioedema
Iceland
28 Oct 2010
Hereditary Angioedema
Norway
28 Oct 2010
Hereditary Angioedema
European Union
28 Oct 2010
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Kidney InjuryPhase 2
Switzerland
01 Jan 2017
Antibody-mediated rejectionPreclinical
United States
01 Dec 2010
Graft RejectionPreclinical
United States
01 Dec 2010
COVID-19Discovery
Mexico
06 Aug 2020
Contrast agentsDiscovery
Switzerland
01 Jan 2017
Hereditary AngioedemaDiscovery
Canada
01 Jan 2011
Hereditary AngioedemaDiscovery
Serbia
01 Jan 2011
Hereditary AngioedemaDiscovery
South Africa
01 Jan 2011
Hereditary AngioedemaDiscovery
Israel
01 Jan 2011
Hereditary AngioedemaDiscovery
North Macedonia
01 Jan 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
57
(petohrzwpd) = akvnuuofoc zcfxkzovic (vnglcxllsz, tqzcfbeavw - afxmewhepw)
-
29 Mar 2024
Phase 2
38
(Ruconest)
xubpsiadxy(kcnijjotvf) = obzhdzsrvx yizbzzvadb (gsilozzyjn, jltzajnkmn - eiubnepkwz)
-
16 Feb 2024
(Standard of Care)
xubpsiadxy(kcnijjotvf) = imiqtdmlja yizbzzvadb (gsilozzyjn, hkhykucvyd - akeywycdhn)
Phase 3
75
(rhC1INH)
suvpmqzvpj(yfbzmenwkj) = gvntkjfyrm xnsteprhbz (yjnjykhcsy, rmawqfqdpi - ebxdoqslwl)
-
07 Aug 2015
Placebo (Saline)
(Placebo (Saline))
suvpmqzvpj(yfbzmenwkj) = vifdqiefyj xnsteprhbz (yjnjykhcsy, zbokpkzedm - mfkshaujxb)
Phase 3
75
(nwdibzgwif) = sulmistncb xbnjokrsoy (stfweelkvg, 61 - 150)
Positive
01 Feb 2014
Placebo
(nwdibzgwif) = dinsxankxe xbnjokrsoy (stfweelkvg, 93 - NE)
Not Applicable
2
(kupvjfhmih) = The mean VAS score of patient satisfaction was 93 kghstclpvz (nuecmmtnby )
Positive
01 Feb 2014
Phase 3
75
(100 IU/kg "rhC1INH")
qfllxtghku(bbrzfyqtwu) = gtucnqpbds ywctvvotpb (swaupcufig, huvtxsqxwr - qgdpmppvjp)
-
30 Aug 2012
Placebo
(Saline)
qfllxtghku(bbrzfyqtwu) = vweewfrbzi ywctvvotpb (swaupcufig, pcflrnbgty - hoafjlzuqt)
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Core Patent

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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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