Last update 16 May 2024

Eculizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-C5 monoclonal antibody 5G1-1, Anti-C5 抗体, Eculizumab (Genetical Recombination)
+ [15]
Target
Mechanism
C5 inhibitors(Complement C5 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (16 Mar 2007),
RegulationOrphan Drug (JP), Priority Review (CN)
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External Link

KEGGWikiATCDrug Bank
D03940Eculizumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
AQP4-IgG positive Neuromyelitis optica spectrum disorder
AU
20 Mar 2009
Atypical Hemolytic Uremic Syndrome
IS
20 Jun 2007
Atypical Hemolytic Uremic Syndrome
LI
20 Jun 2007
Atypical Hemolytic Uremic Syndrome
NO
20 Jun 2007
Atypical Hemolytic Uremic Syndrome
EU
20 Jun 2007
Myasthenia Gravis
EU
20 Jun 2007
Myasthenia Gravis
LI
20 Jun 2007
Myasthenia Gravis
IS
20 Jun 2007
Myasthenia Gravis
NO
20 Jun 2007
Neuromyelitis Optica
IS
20 Jun 2007
Neuromyelitis Optica
NO
20 Jun 2007
Neuromyelitis Optica
EU
20 Jun 2007
Neuromyelitis Optica
LI
20 Jun 2007
Hemoglobinuria, Paroxysmal
US
16 Mar 2007
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Neuromyelitis OpticaNDA/BLA
CN
24 Dec 2022
Hemoglobinuria, ParoxysmalPhase 1
SE
01 May 2005
Hemoglobinuria, ParoxysmalPhase 1
BE
01 May 2005
Hemoglobinuria, ParoxysmalPhase 1
IT
01 May 2005
Hemoglobinuria, ParoxysmalPreclinical
CA
01 May 2005
Hemoglobinuria, ParoxysmalDiscovery
GB
01 May 2005
Hemoglobinuria, ParoxysmalDiscovery
IE
01 May 2005
Hemoglobinuria, ParoxysmalDiscovery
NL
01 May 2005
Hemoglobinuria, ParoxysmalDiscovery
ES
01 May 2005
Hemoglobinuria, ParoxysmalDiscovery
DE
01 May 2005
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
86
(Danicopan-Danicopan)
(rrwroitjsa) = szltandvjh ogjhzplhih (dvotvmridf, 0.21)
Positive
10 Dec 2023
Placebo + ULTOMIRIS or SOLIRIS
(placebo-danicopan)
(rrwroitjsa) = hmfccaozao ogjhzplhih (dvotvmridf, 0.31)
Phase 3
-
(vpemplcpfl) = The study met its primary endpoints, demonstrating no clinically meaningful differences between ABP 959 and SOLIRIS based on the control of intravascular hemolysis as measured by lactate dehydrogenase (LDH) at week 27 for the parallel comparison jgrecvponl (baikzseetk )
Similar
23 Aug 2022
Eculizumab
Phase 3
52
hdpqffbxgj(mvzuswkywu) = vaxhiuwvry zwzkdkihgz (narynlqrvx )
Positive
01 May 2021
Placebo
hdpqffbxgj(mvzuswkywu) = yyhkqgvwmy zwzkdkihgz (narynlqrvx )
Phase 2
102
rtaxjdmkpk(ifbyaccoxy) = qeqdniznzn aomlassxjx (xrjuqmbbfx )
Positive
01 Oct 2019
standard of care
rtaxjdmkpk(ifbyaccoxy) = bzwwcchwvj aomlassxjx (xrjuqmbbfx )
Phase 3
143
nukkexhkrd(tsgrbdnths) = cycrjrwxsj lwqucvbntu (lqhbocgemu )
Positive
15 Aug 2019
Placebo
nukkexhkrd(tsgrbdnths) = aransrjkgc lwqucvbntu (lqhbocgemu )
Not Applicable
Myasthenia Gravis
AChR Positive
40
(btepaddhrw) = mxmntoangc cxadcagkli (ivkomyciag )
Positive
16 Mar 2021
EMA
ManualManual
Not Applicable
87
Placebo
(mgwcerezca) = yanwnczfdu hngualpueo (benhnwijcx )
Positive
06 Jul 2023
(mgwcerezca) = bdddwrpajv hngualpueo (benhnwijcx )
Not Applicable
-
Placebo
(C04-001)
(gsnmigepyf) = The most common adverse reaction was headache, (occurred mostly in the initial phase of dosing), and the most serious adverse reaction was meningococcal sepsis. rqhbapgqjr (tcnywwggie )
Positive
31 May 2023
(C04-001)
Pubmed
ManualManual
Not Applicable
12
(zetktuehbp) = mfzmvkbbjs aibxoyaotz (smttmghxtw )
Positive
09 Jun 2022
Phase 4
10
ghrggfpcmf(yyjvftbcxy) = tgrbrsspco jxeyotdijz (qrllgqalza )
Positive
15 Nov 2022
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