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) |
Therapeutic Areas |
Originator Organization |
Active Organization |
Inactive Organization- |
License 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) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D03940 | Eculizumab |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Delayed Graft Function | Phase 3 | Germany | 25 Jun 2014 | |
| AQP4-IgG positive Optic Neuritis | Phase 3 | United States | 11 Apr 2014 | |
| AQP4-IgG positive Optic Neuritis | Phase 3 | Japan | 11 Apr 2014 | |
| AQP4-IgG positive Optic Neuritis | Phase 3 | Argentina | 11 Apr 2014 | |
| AQP4-IgG positive Optic Neuritis | Phase 3 | Australia | 11 Apr 2014 | |
| AQP4-IgG positive Optic Neuritis | Phase 3 | Croatia | 11 Apr 2014 | |
| AQP4-IgG positive Optic Neuritis | Phase 3 | Czechia | 11 Apr 2014 | |
| AQP4-IgG positive Optic Neuritis | Phase 3 | Denmark | 11 Apr 2014 | |
| AQP4-IgG positive Optic Neuritis | Phase 3 | Germany | 11 Apr 2014 | |
| AQP4-IgG positive Optic Neuritis | Phase 3 | Hong Kong | 11 Apr 2014 |
Not Applicable | 96 | cludoucepg(dhgaqihntd) = jzvnpgkjjk rhrkbgoydq (wzsqbnouad ) | Positive | 06 Dec 2025 | |||
(immune competent cohort) | lrehwnszom(mslcedfego) = eijxqkpuch nsoggbtkyn (eqzkjxnasz ) | ||||||
Not Applicable | 31 | cnhskldfxk(qdvlamhhcb) = mcftbwfbbw rwupecekfg (ewnnqdaoud ) View more | Positive | 06 Dec 2025 | |||
cnhskldfxk(qdvlamhhcb) = eyljoxthjl rwupecekfg (ewnnqdaoud ) View more | |||||||
Not Applicable | 21 | iyvahkubpf(chkrpshihv) = rbyocehbnr jhszokpfkc (cxdhpqemrf ) View more | Positive | 06 Dec 2025 | |||
Not Applicable | 87 | reoqkvwygg(vgaikqpnfc) = vkmotwpymx jhssnbmstq (rjnqsatctg ) View more | Positive | 06 Dec 2025 | |||
reoqkvwygg(vgaikqpnfc) = kzqwdlvaih jhssnbmstq (rjnqsatctg ) View more | |||||||
Not Applicable | 11 | lmqxdznqsx(awggpuzywy) = Sepsis as the cause of death in 3 cases knaehmcfxq (mbrjndwasn ) | Negative | 06 Dec 2025 | |||
Not Applicable | 56 | xpupequujg(dybegdzqsv) = ejsqojecma yyjtmqdbmb (ruglhqbchh, 0.00 - 0.05) View more | Positive | 09 Sep 2025 | |||
(switched from rituximab) | xpupequujg(dybegdzqsv) = vxjjtmnaga yyjtmqdbmb (ruglhqbchh ) View more | ||||||
Not Applicable | 52 | pnlqwmmtrz(rynorgular) = occurred in 30.8% ogdixalyrh (yhsfuwohyd ) View more | - | 14 May 2025 | |||
Not Applicable | Myasthenia Gravis anti-acetylcholine receptor antibody-positive (AChR-Ab+) | 254 | dzjrvgginw(fnuyhpcnqi) = 40.5% experienced adverse drug reactions (ADRs) zquopjvvcx (ooednljhva ) View more | Positive | 07 Apr 2025 | ||
Not Applicable | 30 | ixkyfgrcsq(ptphojgcyp) = wzmanplwwk vpjfwfhxop (jemobdlbam, 24.0 - 49.7) | Positive | 07 Apr 2025 | |||
ixkyfgrcsq(ptphojgcyp) = igpadlkslq vpjfwfhxop (jemobdlbam, 0.7 - 1.3) | |||||||
Not Applicable | - | pphcnuvwkb(swmmxxnzyi) = ylqcfdhbdt vvgbxevfic (vcaqkjdhdi, 230.0 - 362.0) View more | - | 08 Dec 2024 | |||
qkgrbdachl(rzyrjlcylo) = ncycqlvser fjhaqhiuho (ofmgytotzc, 11.5% - 36.4%) |






