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Drug ReportsC1 esterase inhibitor
Conestat alfa
Ruconest (conestat alfa) is a protein pharmaceutical. Conestat alfa was first approved as Ruconest on 2010-10-28. It has been approved in Europe to treat hereditary angioedemas.
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
berinertBiologic Licensing Application2009-11-10
cinryzeBiologic Licensing Application2010-11-01
ruconestBiologic Licensing Application2022-10-24
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
B: Blood and blood forming organ drugs
B06: Other hematological agents in atc
B06A: Other hematological agents in atc
B06AC: Drugs used in hereditary angioedema
B06AC04: Conestat alfa
HCPCS
No data
Clinical
Clinical Trials
93 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AngioedemaD000799EFO_0005532T78.36202741463
Hereditary angioedemasD054179EFO_00041317212351361
Hereditary angioedema types i and iiD0568292531110
Covid-19D000086382314
FatigueD005221HP_0012378R53.8311
Chronic fatigue syndromeD015673EFO_0004540G93.3111
Common variable immunodeficiencyD017074EFO_0000367D8311
AsthmaD001249EFO_0000270J4511
Prodromal symptomsD06270611
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Inborn genetic diseasesD030342EFO_0000508324
Wounds and injuriesD014947T14.8213
InflammationD007249MP_0001845213
SepsisD018805HP_0100806A41.922
EndotoxemiaD019446112
Multiple organ failureD009102EFO_1001373112
Innate immunityD00711311
Hip fracturesD006620EFO_0003964S72.0011
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N19313
Acute kidney injuryD058186HP_0001919N1733
IschemiaD007511EFO_000055622
Reperfusion injuryD015427122
Kidney transplantationD016030122
Chronic kidney failureD007676EFO_0003884N18.9222
Kidney diseasesD007674EFO_0003086N08222
Delayed graft functionD051799212
Graft rejectionD00608422
Ischemic strokeD000083242112
Show 21 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neuromyelitis opticaD009471EFO_0004256G36.011
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Immunologic testsD00715911
Graft vs host diseaseD006086D89.8111
Systemic mastocytosisD034721C96.2111
UrticariaD014581EFO_0005531L5011
MastocytosisD008415D47.0911
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameConestat alfa
INNconestat alfa
Description
C1-inhibitor (C1-inh, C1 esterase 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. C1-inhibitor is an acute-phase protein that circulates in blood at levels of around 0.25 g/L. The levels rise ~2-fold during inflammation. C1-inhibitor irreversibly binds to and inactivates C1r and C1s proteases in the C1 complex of classical pathway of complement. MASP-1 and MASP-2 proteases in MBL complexes of the lectin pathway are also inactivated. This way, C1-inhibitor prevents the proteolytic cleavage of later complement components C4 and C2 by C1 and MBL. Although named after its complement inhibitory activity, C1-inhibitor also inhibits proteases of the fibrinolytic, clotting, and kinin pathways. Note that C1-inhibitor is the most important physiological inhibitor of plasma kallikrein, FXIa, and FXIIa.
Classification
Protein
Drug classenzyme inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID
RxCUI
ChEMBL IDCHEMBL2108350
ChEBI ID
PubChem CID
DrugBankDB06404
UNII ID5QS67N4551 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Ruconest Pharming
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,691 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,076 adverse events reported
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