eculizumab
Trade name: Soliris
Approved
Mar 16, 2007
Eculizumab, sold under the brand name Soliris among others, is a recombinant humanized monoclonal antibody used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica. In people with paroxysmal nocturnal hemoglobinuria, it reduces both the destruction of red blood cells and need for blood transfusion, but does not appear to affect the risk of death. Eculizumab was the first medication approved for each of its uses, and its approval was granted based on small trials. It is given by intravenous infusion. It is a humanized monoclonal antibody functioning as a terminal complement inhibitor. It binds to the complement C5 protein and inhibits activation of the complement system, a part of the body's immune system. This binding prevents the breakdown of red blood cells in the bloodstream in people with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. — Wikipedia
Clinical trial activity
104 trials · 66 clinical orgs · 3 marketing orgs
Earliest trial started Apr 1, 2000 (NCT00005571)
Timeline
2000s
Indications
Studied for
- Anemia, Hemolytic, Autoimmune · Phase 2
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis · Phase 2
- Antiphospholipid Syndrome · Phase 2
- Asthma · Phase 2
- Autoimmune Diseases · Phase 2
- Blood Platelet Disorders · Phase 2
- Cardiopulmonary Bypass · Phase 3
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 2
- Complement Pathway, Classical · Phase 2
- Coronary Artery Bypass · Phase 3
- Coronary Artery Disease · Phase 3
- COVID-19 · Phase 2
- Delayed Graft Function · Phase 2/Phase 3
- Dermatomyositis · Phase 2
- Diabetes Mellitus · Phase 2
- Drugs, Investigational · Phase 2
- End Stage Liver Disease · Early Phase 1
- Escherichia coli Infections · Phase 2/Phase 3
- Genetic Diseases, Inborn · Phase 3
- Glomerulonephritis, Membranoproliferative · Phase 2
- Graft Rejection · Phase 4
- Guillain-Barre Syndrome · Phase 3
- Healthy Volunteers · Phase 1
- HELLP Syndrome · Phase 2
- Hemolysis · Phase 1/Phase 2
- Hemolytic-Uremic Syndrome · Phase 3
- Hypertension · Phase 3
- Kidney Diseases · Phase 1
- Kidney Failure, Chronic · Phase 2
- Kidney Transplantation · Phase 3
- Leukemia · Phase 3
- Livedoid Vasculopathy · Phase 4
- Macular Degeneration · Phase 2
- Maternal Health · Phase 1
- Multiple Organ Failure · Phase 2
- Myasthenia Gravis · Phase 3
- Myocardial Infarction · Phase 3
- Neonatology · Phase 1
- Neuromyelitis Optica · Phase 4
- Pediatrics · Phase 3
- Pre-Eclampsia · Phase 2
- Pregnancy Complications · Phase 2
- Renal Insufficiency · Phase 2
- Reperfusion Injury · Phase 2
- SARS-CoV-2 · Phase 2
- Thrombocytopenia · Phase 2
- Thrombotic Microangiopathies · Phase 3
- Vascular Grafting · Phase 4
- Ventricular Dysfunction, Left · Phase 4
Mechanism of action
- Complement C5INHIBITOR
C5 inhibitor
Approval history
- approvedMar 16, 2007
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaEculizumab ↗
- NCATSA3ULP0F556 ↗
- ChEMBLCHEMBL2107979 ↗
- ChEMBLCHEMBL1201828 ↗
- WikipediaPexelizumab ↗
Also known as
- 5g1.1
- 5g1.1
- 5g1.1-sc
- eculizumab
- eculizumab
- eculizumab
- eculizumab
- eculizumab
- eculizumab
- eculizumab
- eculizumab
- eculizumab
- h5g1.1
- h5g1.1
- h5g1.1
- h5g1.1-sc
- h5g1.1 scfv
- h5g1.1-scfv
- h5g1.1 scfv (cdr)
- h5g1.1vhc+h5g1.1vlc
- h5g1.1vhc+h5g1.1vlc
- pexelizumab
- pexelizumab
- pexelizumab
- pexelizumab
- soliris
- soliris
- soliris
- soliris
- soliris
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07177859 | Phase 3 | Nov 30, 2025 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT07010302 | Phase 4 | Nov 30, 2025 | Harvard University, Humboldt University, Patient-Centered Outcomes Research Institute |
| NCT07184840 | Phase 2 | Sep 9, 2025 | Tianjin Medical University |
| NCT06799546 | Phase 3 | Feb 20, 2025 | Haisco Pharmaceutical |
| NCT06764160 | Phase 3 | Jan 6, 2025 | Alexion |
| NCT06724809 | Phase 3 | Dec 24, 2024 | Alexion, AstraZeneca, Fudan University |
| NCT06673394 | Phase 2 | Dec 1, 2024 | Tianjin Medical University |
| NCT06593938 | Phase 3 | Sep 30, 2024 | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| NCT06932744 | Phase 3 | Aug 30, 2024 | Wuhan Createrna Science and Technology Co., Ltd |
| NCT06513338 | Phase 2 | Aug 1, 2024 | Peking University |
| NCT06453135 | Phase 1/Phase 2 (Phase 2) | Jul 31, 2024 | Sichuan University |
| NCT05726916 | Phase 3 | Oct 15, 2023 | Assistance Publique - Hôpitaux de Paris |
| NCT05876351 | Phase 3 | Jul 14, 2023 | Alexion, AstraZeneca |
| NCT05886244 | Phase 3 | Jul 5, 2023 | Alexion, AstraZeneca |
| NCT05863442 | Phase 1 | Apr 10, 2023 | Turgut Ardika PTY LTD |
| NCT05702996 | Phase 3 | Mar 31, 2023 | Rouen Normandy University |
| NCT05646563 | Phase 2 | Feb 28, 2023 | NovelMed Therapeutics |
| NCT05131204 | Phase 3 | Mar 31, 2022 | Regeneron |
| NCT05116774 | Phase 2 | Nov 30, 2021 | BioCryst, University of London |
| NCT04859608 | Phase 4 | Nov 1, 2021 | University Hospital, Tours |
Organizations
Research & Development (66)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Alexion | For profit | 56 | 39 | 5 | 2002 |
| Mayo Clinic | Academic/Hospital | 4 | 4 | 2 | 2008 |
| AstraZeneca | For profit | 3 | 0 | 1 | 2023 |
| Biocad | For profit | 3 | 3 | 2 | 2018 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 3 | 3 | 2 | 2004 |
| AO GENERIUM | For profit | 2 | 2 | 1 | 2017 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 2 | 2 | 2 | 2020 |
| Cedars-Sinai Medical Center | Academic/Hospital | 2 | 2 | 2 | 2012 |
| Chugai | For profit | 2 | 0 | 1 | 2020 |
| Harvard University | Academic/Hospital | 2 | 2 | 2 | 2013 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 2 | 0 | 1 | 2011 |
| Johns Hopkins University | Academic/Hospital | 2 | 2 | 2 | 2009 |
| National Institutes of Health (NIH) | Government | 2 | 0 | 2 | 2011 |
| Procter and Gamble | For profit | 2 | 1 | 1 | 2004 |
| Roche | For profit | 2 | 2 | 1 | 2020 |
| Samsung | For profit | 2 | 2 | 2 | 2018 |
| Tianjin Medical University | Academic/Hospital | 2 | 2 | 1 | 2024 |
| Yale University | Academic/Hospital | 2 | 2 | 1 | 2011 |
| Achillion Pharmaceuticals | For profit | 1 | 1 | 1 | 2018 |
| Amgen | For profit | 1 | 1 | 1 | 2019 |