Eculizumab is a humanized monoclonal antibody complement inhibitor targeting C5, marketed as Soliris. It is used in disorders including paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica spectrum disorder. It is administered intravenously and is prescription-only.
The FDA has accepted Hansa Biopharma's Biologics License Application for imlifidase, a desensitization treatment for highly sensitized adult kidney transplant patients with positive crossmatch against deceased donors, with a PDUFA date of December 19, 2026.
Over 10 companies are developing 12+ pipeline therapies for Neuromyelitis Optica Spectrum Disorder, including Roche's satralizumab Phase III pediatric trial and multiple anti-CD20 monoclonal antibody candidates.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06987864 |
An Extension Clinical Study of BCD-148 for the Treatment of Patients With PNH Previously Treated in Clinical Study No. BCD-148-2/NOCTURN |
COMPLETED | PHASE3 |
| NCT06764160 |
Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG |
COMPLETED | PHASE3 |
| NCT06724809 |
Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06513338 |
Complement C5 mAb in the Treatment of Anti-GBM Disease |
COMPLETED | PHASE2 |
| NCT06453135 |
Eculizumab for Prevention of Antibody-Mediated Rejection in ABO-Incompatible Living Donor Kidney Transplantation |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT05886244 |
Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China |
COMPLETED | PHASE3 |
| NCT05876351 |
Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China |
COMPLETED | PHASE3 |
| NCT05133531 |
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 |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05131204 |
Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria |
TERMINATED | PHASE3 |
| NCT05116774 |
BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants With Inadequate Response to C5 Inhibitor Therapy |
TERMINATED | PHASE2 |
