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Eculizumab (Soliris®)
Eculizumab is a monoclonal antibody that blocks complement protein C5, preventing the formation of the membrane attack complex and reducing complement-mediated cell destruction.
Eculizumab is a monoclonal antibody that blocks complement protein C5, preventing the formation of the membrane attack complex and reducing complement-mediated cell destruction. Used for Paroxysmal nocturnal hemoglobinuria (PNH), Atypical hemolytic uremic syndrome (aHUS), Generalized myasthenia gravis (gMG).
At a glance
| Generic name | Eculizumab (Soliris®) |
|---|---|
| Sponsor | Massachusetts General Hospital |
| Drug class | Complement C5 inhibitor |
| Target | Complement protein C5 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Eculizumab binds to C5, a key component of the complement cascade, preventing its cleavage into C5a and C5b. This blocks the formation of the terminal complement complex (C5b-9, also called the membrane attack complex), which is responsible for destroying cells in complement-mediated diseases. By inhibiting this final step of the complement pathway, eculizumab reduces hemolysis and inflammation in conditions driven by complement activation.
Approved indications
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Atypical hemolytic uremic syndrome (aHUS)
- Generalized myasthenia gravis (gMG)
- Neuromyelitis optica spectrum disorder (NMOSD)
Common side effects
- Meningococcal infection
- Headache
- Nausea
- Fatigue
- Back pain
- Infusion reactions
Key clinical trials
- Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD (PHASE4)
- Danicopan Early Access Program
- Study of NM8074 in Adult PNH Patients with Inadequate Response to Soliris (PHASE2)
- A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria (PHASE3)
- Eculizumab in Hypertensive Emergency-associated Hemolytic Uremic Syndrome (PHASE3)
- Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants (PHASE1)
- Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria®
- Observational Study of Elizaria® in aHUS Patients
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |