Last update 26 May 2025

Eculizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-C5 monoclonal antibody 5G1-1, Eculizumab (Genetical Recombination), Eculizumab (genetical recombination) (JAN)
+ [16]
Target
Action
inhibitors
Mechanism
C5 inhibitors(Complement C5 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (16 Mar 2007),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia)
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Structure/Sequence

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
Australia
20 Mar 2009
Atypical Hemolytic Uremic Syndrome
European Union
20 Jun 2007
Atypical Hemolytic Uremic Syndrome
Iceland
20 Jun 2007
Atypical Hemolytic Uremic Syndrome
Liechtenstein
20 Jun 2007
Atypical Hemolytic Uremic Syndrome
Norway
20 Jun 2007
Myasthenia Gravis
European Union
20 Jun 2007
Myasthenia Gravis
Iceland
20 Jun 2007
Myasthenia Gravis
Liechtenstein
20 Jun 2007
Myasthenia Gravis
Norway
20 Jun 2007
Neuromyelitis Optica
European Union
20 Jun 2007
Neuromyelitis Optica
Iceland
20 Jun 2007
Neuromyelitis Optica
Liechtenstein
20 Jun 2007
Neuromyelitis Optica
Norway
20 Jun 2007
Hemoglobinuria, Paroxysmal
United States
16 Mar 2007
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Delayed Graft FunctionPhase 3
United States
21 Aug 2014
Delayed Graft FunctionPhase 3
Australia
21 Aug 2014
Delayed Graft FunctionPhase 3
Brazil
21 Aug 2014
Delayed Graft FunctionPhase 3
Canada
21 Aug 2014
Delayed Graft FunctionPhase 3
Czechia
21 Aug 2014
Delayed Graft FunctionPhase 3
France
21 Aug 2014
Delayed Graft FunctionPhase 3
Germany
21 Aug 2014
Delayed Graft FunctionPhase 3
Italy
21 Aug 2014
Delayed Graft FunctionPhase 3
Spain
21 Aug 2014
AQP4-IgG positive Optic NeuritisPhase 3
United States
11 Apr 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
18
gjhvtbjukz = ofqinwuhlt dphfzbdhsf (lcfpvzwpws, nwlpxuaizr - osyijaehjw)
-
12 Aug 2024
Phase 2
17
(at 26 wks)
hjtdwdvmic(hiblmbwmdd) = kgncatmxmg zktjcjgljv (zsitfpdllr )
Positive
19 Jul 2024
(at 2 yrs)
hjtdwdvmic(hiblmbwmdd) = cnholkmjnh zktjcjgljv (zsitfpdllr )
Not Applicable
19
(<2 yrs)
qtqhtgbgst(irwyskcpoi) = qbjupmfejl cvaluotidr (mkjkwemevs )
Positive
19 Jul 2024
(2 to <12 yrs)
qtqhtgbgst(irwyskcpoi) = oetkvjdebv cvaluotidr (mkjkwemevs )
Phase 2
41
nmtaalsdtz(rebkmkdepd) = yahixocgty mxpzncoluc (pungdvyrfv, 40 - 72)
Positive
19 Jul 2024
Phase 2
22
(Patients 1 month to <12 years)
eozyvymxnd(upurnuafvj) = nyrewhuooz lkniwzvbgq (xybaaluams, 36 - 83)
Positive
19 Jul 2024
(All Patients)
eozyvymxnd(upurnuafvj) = gcnxcqcprx lkniwzvbgq (xybaaluams, 41 - 83)
Phase 3
87
Placebo
wnxogpcgur(fbbhgknwyx) = yrngzauasg qzuktrltbj (vjqiegtjnv )
Positive
19 Jul 2024
wnxogpcgur(fbbhgknwyx) = zwulxispss qzuktrltbj (vjqiegtjnv )
Phase 2
20
(at 26 wks)
tsxyovbvjr(kgldxvbiws) = kfghzwhhef pcyrkpogek (hhbyuzmxut )
Positive
19 Jul 2024
(at 2 yrs)
tsxyovbvjr(kgldxvbiws) = wujqfhzpny pcyrkpogek (hhbyuzmxut )
Phase 3
68
-
Positive
14 May 2024
(patients with baseline IO)
kuwkzehjyz(cosvzecwwc) = lapfwteagy leidbrgqsr (dncsakkegi, 8.0)
Not Applicable
200
epkydrsdka(jfqmbnywmk) = nrxcjszrjm jryvdgewer (kuajzrwduv )
Positive
14 May 2024
epkydrsdka(jfqmbnywmk) = mkdxebqvbz jryvdgewer (kuajzrwduv )
Not Applicable
Atypical Hemolytic Uremic Syndrome
genetic mutations in the alternate complement pathway
6
Eculizumab sparing protocols
mojwydgrxr(lbljmvnrzr) = None had BK virus infection exlimacsbo (eepqnhzypc )
Positive
01 Apr 2024
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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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