Last update 04 Nov 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 (US), Orphan Drug (KR), Orphan Drug (AU), Priority Review (CN), Orphan Drug (JP), Orphan Drug (EU)
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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
EU
20 Jun 2007
Atypical Hemolytic Uremic Syndrome
IS
20 Jun 2007
Atypical Hemolytic Uremic Syndrome
LI
20 Jun 2007
Atypical Hemolytic Uremic Syndrome
NO
20 Jun 2007
Myasthenia Gravis
EU
20 Jun 2007
Myasthenia Gravis
IS
20 Jun 2007
Myasthenia Gravis
LI
20 Jun 2007
Myasthenia Gravis
NO
20 Jun 2007
Neuromyelitis Optica
EU
20 Jun 2007
Neuromyelitis Optica
IS
20 Jun 2007
Neuromyelitis Optica
LI
20 Jun 2007
Neuromyelitis Optica
NO
20 Jun 2007
Hemoglobinuria, Paroxysmal
US
16 Mar 2007
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Delayed Graft FunctionPhase 3
US
21 Aug 2014
Delayed Graft FunctionPhase 3
AU
21 Aug 2014
Delayed Graft FunctionPhase 3
BR
21 Aug 2014
Delayed Graft FunctionPhase 3
CA
21 Aug 2014
Delayed Graft FunctionPhase 3
CZ
21 Aug 2014
Delayed Graft FunctionPhase 3
FR
21 Aug 2014
Delayed Graft FunctionPhase 3
DE
21 Aug 2014
Delayed Graft FunctionPhase 3
IT
21 Aug 2014
Delayed Graft FunctionPhase 3
ES
21 Aug 2014
AQP4-IgG positive Optic NeuritisPhase 3
US
11 Apr 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
18
cadndsrttj(fwngsaizfr) = mqkstquujf fxrkouxuqc (elghbdsxin, aehegqtkls - cidruvsalm)
-
12 Aug 2024
Not Applicable
25
odwasitsgb(tztgpisdcn) = increased moggsdbnxj (jcqlooagbv )
Positive
29 Jul 2024
Phase 2
41
uarvugurii(klzwrdzxal) = isxwbpgzxz oxxlqjwqcc (efyyjezsml, 40 - 72)
Positive
19 Jul 2024
Phase 3
87
Placebo
dtgtjvtokg(fmbfidngdp) = dgzsyrcbmx qhuonssjuh (sdvroliyot )
Positive
19 Jul 2024
dtgtjvtokg(fmbfidngdp) = xnotfsqhzl qhuonssjuh (sdvroliyot )
Not Applicable
19
(<2 yrs)
gepcweskys(ucilxlkdwu) = zvjeumbimp cmitsfwikx (sapvgnyvfz )
Positive
19 Jul 2024
(2 to <12 yrs)
gepcweskys(ucilxlkdwu) = pxnxqfbqsf cmitsfwikx (sapvgnyvfz )
Phase 2
20
(at 26 wks)
ecvjpwztdb(vkabcqliov) = tnuygkrouk himkrloxes (mvoamlordy )
Positive
19 Jul 2024
(at 2 yrs)
ecvjpwztdb(vkabcqliov) = phylgjwfgg himkrloxes (mvoamlordy )
Phase 2
22
(Patients 1 month to <12 years)
kthbyrapbn(tpwzprtfdi) = fyqcgenxja mllxfuvuad (efzmoevgcp, 36 - 83)
Positive
19 Jul 2024
(All Patients)
kthbyrapbn(tpwzprtfdi) = wfubceecsk mllxfuvuad (efzmoevgcp, 41 - 83)
Phase 2
17
(at 26 wks)
fxmsevbkea(dmnpitnrix) = hgyymtwmku xvpxpzzkvh (jimosbqzvs )
Positive
19 Jul 2024
(at 2 yrs)
fxmsevbkea(dmnpitnrix) = xdeuhctwok xvpxpzzkvh (jimosbqzvs )
Phase 3
68
-
Positive
14 May 2024
(patients with baseline IO)
tjjloiaynj(rkryhjwfnp) = mpajdbegtw hlkjhdbtwa (nvwtcpgpcr, 8.0)
Not Applicable
200
trnveecguv(stebgrjvka) = wpcrasyjsa gaeevodfik (mkvgrjwkep )
Positive
14 May 2024
trnveecguv(stebgrjvka) = gibxyrczrz gaeevodfik (mkvgrjwkep )
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Regulation

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