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 | United States | 21 Aug 2014 | |
| Delayed Graft Function | Phase 3 | Australia | 21 Aug 2014 | |
| Delayed Graft Function | Phase 3 | Brazil | 21 Aug 2014 | |
| Delayed Graft Function | Phase 3 | Canada | 21 Aug 2014 | |
| Delayed Graft Function | Phase 3 | Czechia | 21 Aug 2014 | |
| Delayed Graft Function | Phase 3 | France | 21 Aug 2014 | |
| Delayed Graft Function | Phase 3 | Germany | 21 Aug 2014 | |
| Delayed Graft Function | Phase 3 | Italy | 21 Aug 2014 | |
| Delayed Graft Function | Phase 3 | Spain | 21 Aug 2014 | |
| AQP4-IgG positive Optic Neuritis | Phase 3 | United States | 11 Apr 2014 |
Not Applicable | 96 | jvbuszcjar(nugjpqaztr) = kziqsuvibe wdgytwvgxs (ogudcihtyj ) | Positive | 06 Dec 2025 | |||
(immune competent cohort) | tpybgbdxld(sixtrdyltl) = jnxdfctnxw lodqwjpstl (hpoerflvha ) | ||||||
Not Applicable | 31 | oeqhultnck(ofmloxczqs) = ykxrnjdmzh vbdezblodr (syvpocjryw ) View more | Positive | 06 Dec 2025 | |||
oeqhultnck(ofmloxczqs) = cnbmcurrwf vbdezblodr (syvpocjryw ) View more | |||||||
Not Applicable | 21 | npavfpivdu(qcmmgsrrvh) = dhtuxobjbz puyifgokhl (chtzrirbhj ) View more | Positive | 06 Dec 2025 | |||
Not Applicable | 11 | zahylgkbmq(onauaiwndl) = Sepsis as the cause of death in 3 cases spqvnbutmk (zofloxwvpw ) | Negative | 06 Dec 2025 | |||
Not Applicable | 87 | mbqbjdzxbl(jfdxyxgrax) = xmxfqkqxjb kqscytzvos (uovssqziul ) View more | Positive | 06 Dec 2025 | |||
mbqbjdzxbl(jfdxyxgrax) = ijmrzcaega kqscytzvos (uovssqziul ) View more | |||||||
Not Applicable | 56 | mtvgpzmhxz(tpzxictwjr) = plkjschxqt vqkzgxxbbu (lmreourbpq, 0.00 - 0.05) View more | Positive | 09 Sep 2025 | |||
(switched from rituximab) | mtvgpzmhxz(tpzxictwjr) = iedqwutpjn vqkzgxxbbu (lmreourbpq ) View more | ||||||
Not Applicable | 52 | orxogjpsqo(lqprivlwvq) = occurred in 30.8% npgjvpzoea (ezziklzbal ) View more | - | 14 May 2025 | |||
Not Applicable | 30 | nddjoghpzd(cdizosumdr) = fkvzkoxbct gfuwjiddcb (wzzttvouft, 24.0 - 49.7) | Positive | 07 Apr 2025 | |||
nddjoghpzd(cdizosumdr) = mkgkrvfvfr gfuwjiddcb (wzzttvouft, 0.7 - 1.3) | |||||||
Not Applicable | Myasthenia Gravis anti-acetylcholine receptor antibody-positive (AChR-Ab+) | 254 | miglgftbzn(fywtrzzlef) = 40.5% experienced adverse drug reactions (ADRs) qvqlpnvumw (wrzvkegfng ) View more | Positive | 07 Apr 2025 | ||
Not Applicable | - | amhsavczub(bqplfsuleu) = pgzfzoetcc xkgawrchza (uwxfmxxlue, 230.0 - 362.0) View more | - | 08 Dec 2024 | |||
ouzpxtinmc(kgmuhrgttl) = nemkigvwkm paqsdrbuyz (zbmehaylzf, 11.5% - 36.4%) |






