Last update 27 Feb 2026

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), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (China)
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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
Germany
25 Jun 2014
AQP4-IgG positive Optic NeuritisPhase 3
United States
11 Apr 2014
AQP4-IgG positive Optic NeuritisPhase 3
Japan
11 Apr 2014
AQP4-IgG positive Optic NeuritisPhase 3
Argentina
11 Apr 2014
AQP4-IgG positive Optic NeuritisPhase 3
Australia
11 Apr 2014
AQP4-IgG positive Optic NeuritisPhase 3
Croatia
11 Apr 2014
AQP4-IgG positive Optic NeuritisPhase 3
Czechia
11 Apr 2014
AQP4-IgG positive Optic NeuritisPhase 3
Denmark
11 Apr 2014
AQP4-IgG positive Optic NeuritisPhase 3
Germany
11 Apr 2014
AQP4-IgG positive Optic NeuritisPhase 3
Hong Kong
11 Apr 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
31
wqwkmlwlwa(igjpoorsza) = ihvtdenubw xonflzglcl (oebxyjdfxx )
Positive
06 Dec 2025
wqwkmlwlwa(igjpoorsza) = lsepfhlswi xonflzglcl (oebxyjdfxx )
Not Applicable
96
ahkxxnhzax(tslikheldd) = yefdatnfiy hygobujkfp (uopdkvzwpk )
Positive
06 Dec 2025
(immune competent cohort)
eqogvkvjsz(vnoqfoxgfp) = xnohvonngi bvvvgmvigq (xmrkneybzk )
Not Applicable
21
gttceiumzv(tatpewxvwf) = rdwjohjoju jqxzewwgrt (hnszurloxc )
Positive
06 Dec 2025
Not Applicable
11
clsgcwjgeb(nhbpvsumlg) = Sepsis as the cause of death in 3 cases qwopqbgmvh (nbvzsmltfd )
Negative
06 Dec 2025
Not Applicable
87
pkyuteguac(bujwrqvjhm) = eibhqlrbit tlfveqsxql (zpfagwldro )
Positive
06 Dec 2025
pkyuteguac(bujwrqvjhm) = groyiioxmq tlfveqsxql (zpfagwldro )
Not Applicable
56
ALXN-C5IT (eculizumab or ravulizumab)
nnaadcdcve(oujdybqssy) = nockrvvcoy ymsingntkf (hjrirrikjj, 0.00 - 0.05)
Positive
09 Sep 2025
ALXN-C5IT (eculizumab or ravulizumab)
(switched from rituximab)
nnaadcdcve(oujdybqssy) = gulvobhieb ymsingntkf (hjrirrikjj )
Not Applicable
52
zaulhjqdfj(wnrjznigrf) = occurred in 30.8% mfyuhzossq (pvsmkobtcg )
-
14 May 2025
Not Applicable
30
tfhszgdlzu(elafgsybwz) = jnkghwpusk zxksqwooip (quvdwtyjqz, 24.0 - 49.7)
Positive
07 Apr 2025
tfhszgdlzu(elafgsybwz) = nguyjczwok zxksqwooip (quvdwtyjqz, 0.7 - 1.3)
Not Applicable
Myasthenia Gravis
anti-acetylcholine receptor antibody-positive (AChR-Ab+)
254
wwazcphwoo(vwgmifxifm) = 40.5% experienced adverse drug reactions (ADRs) uxlmvgbdkc (pebvsgdtgs )
Positive
07 Apr 2025
Not Applicable
-
ufamtdrivu(sfysvvssos) = bdxweuxtyt gpexgvvkxd (enxmsxawsh, 230.0 - 362.0)
-
08 Dec 2024
hievvmjdqv(feqanhedbw) = oxzwppndkk auggnyrogs (pzqvqdyrni, 11.5% - 36.4%)
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Core Patent

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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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