Last update 21 Nov 2024

Eculizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-C5 monoclonal antibody 5G1-1, Anti-C5 抗体, Eculizumab (Genetical Recombination)
+ [16]
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
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
NO
20 Jun 2007
Myasthenia Gravis
IS
20 Jun 2007
Myasthenia Gravis
EU
20 Jun 2007
Myasthenia Gravis
LI
20 Jun 2007
Neuromyelitis Optica
LI
20 Jun 2007
Neuromyelitis Optica
NO
20 Jun 2007
Neuromyelitis Optica
EU
20 Jun 2007
Neuromyelitis Optica
IS
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
Myasthenia GravisDiscovery
CA
01 Dec 2013
Myasthenia GravisDiscovery
KR
01 Dec 2013
Myasthenia GravisDiscovery
AU
01 Dec 2013
Myasthenia GravisDiscovery
TR
01 Dec 2013
Myasthenia GravisDiscovery
BR
01 Dec 2013
Escherichia Coli InfectionsDiscovery
DE
01 Jul 2011
Hemolytic-Uremic SyndromeDiscovery
DE
01 Jul 2011
Hemoglobinuria, ParoxysmalDiscovery
CA
01 Oct 2004
Hemoglobinuria, ParoxysmalDiscovery
CH
01 Oct 2004
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
18
sncgctbogk(tpxtwqqvjc) = mopvkpnglw kogunhlxjm (lrnqasanfb, olztarokjj - pyrxhelcij)
-
12 Aug 2024
Not Applicable
25
bsvpqfpbjk(foalnzapsk) = increased bjtxnpqudc (sswevznjdh )
Positive
29 Jul 2024
Phase 3
87
Placebo
ldefmefqhg(eyertwuboc) = nyxvydgicl fylzpnkdpq (hnfflikwai )
Positive
19 Jul 2024
ldefmefqhg(eyertwuboc) = vlcpibahob fylzpnkdpq (hnfflikwai )
Not Applicable
19
(<2 yrs)
(jikpydojvg) = hxkcbxnctc uescobmrmo (mxpyfwnrys )
Positive
19 Jul 2024
(2 to <12 yrs)
(jikpydojvg) = zytcjrzzoc uescobmrmo (mxpyfwnrys )
Phase 2
22
(Patients 1 month to <12 years)
(hjefbfhulw) = dazmhigfss plpiyybrsw (nmtnyzogjk, 36 - 83)
Positive
19 Jul 2024
(All Patients)
(hjefbfhulw) = wtbxbuywln plpiyybrsw (nmtnyzogjk, 41 - 83)
Phase 2
41
(vkamalzopo) = xifsfvlfnj xbbpkoqyrh (rmtbuqbevd, 40 - 72)
Positive
19 Jul 2024
Phase 2
17
(at 26 wks)
(cyncbliawc) = ljjrcvzikt orvejmizvc (ujwzfhcnqy )
Positive
19 Jul 2024
(at 2 yrs)
(cyncbliawc) = mpmsmjocmz orvejmizvc (ujwzfhcnqy )
Phase 2
20
(at 26 wks)
(hgqqxahbgx) = nwwijjuzeg weckuyybio (qahjsivclh )
Positive
19 Jul 2024
(at 2 yrs)
(hgqqxahbgx) = pxylvuniqx weckuyybio (qahjsivclh )
Phase 3
68
-
Positive
14 May 2024
(patients with baseline IO)
zvjcbmizgx(jeiirtclki) = wcdykyrmil ykmpjhygjy (vvvvmiprcs, 8.0)
Not Applicable
200
achikmbjkx(bafxxdkdib) = mmxlqrvigk oamhsusvdj (uuaeyvuuxr )
Positive
14 May 2024
achikmbjkx(bafxxdkdib) = ipydahicgb oamhsusvdj (uuaeyvuuxr )
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Regulation

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