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Soliris (eculizumab)
Soliris works by inhibiting the complement system by blocking the action of C5.
Soliris works by inhibiting the complement system by blocking the action of C5. Used for Paroxysmal nocturnal hemoglobinuria (PNH), Atypical hemolytic uremic syndrome (aHUS).
At a glance
| Generic name | Soliris (eculizumab) |
|---|---|
| Sponsor | Samsung Bioepis Co., Ltd. |
| Drug class | Monoclonal antibody |
| Target | C5 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Soliris specifically binds to C5 and prevents its cleavage into C5a and C5b, thereby inhibiting the formation of the membrane attack complex and reducing the activation of the complement system. This action reduces the destruction of red blood cells and the activation of the immune system in patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
Approved indications
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Atypical hemolytic uremic syndrome (aHUS)
Common side effects
- Headache
- Nausea
- Diarrhea
- Muscle spasms
- Fatigue
Key clinical trials
- A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works (PHASE3)
- Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD (PHASE4)
- Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study (PHASE4)
- Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
- Danicopan Early Access Program
- A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment (PHASE3)
- Modified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder (PHASE4)
- Registry of Participants With Generalized Myasthenia Gravis Treated With Alexion C5 Inhibition Therapies (C5ITs)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Soliris (eculizumab) CI brief — competitive landscape report
- Soliris (eculizumab) updates RSS · CI watch RSS
- Samsung Bioepis Co., Ltd. portfolio CI