66 completed, 14 terminated, 6 active not recruiting, 6 unknown. 47 Phase 2, 42 Phase 3, 13 Phase 1, 4 Phase 4, 1 Early Phase 1.
Follow eculizumab: new trials by email Literature Review of eculizumab trials Research Report on eculizumab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of NM8074 in Adult PNH Patients With Inadequate Response to Soliris NM8074, Soliris - Paroxysmal Nocturnal Hemoglobinuria | Phase 2 | Not yet recruiting | NovelMed Therapeutics | 12 | 2027-01-01 | 2026-04-13 |
| A Multicenter, Randomized, Open-Label, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of VSA012 Injection in Participants With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy VSA012, Eculizumab (Soliris®) - Paroxysmal Nocturnal Hemoglobinuria, PNH | Phase 3 | Not yet recruiting | Bisirna Therapeutics (Suzhou) Co., Ltd. | 70 | 2026-10-29 | 2026-09-11 |
| Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD Rituximab (R), Eculizumab (Soliris®), Ravulizumab - NMOSD | Phase 4 | Recruiting | Massachusetts General Hospital | 540 | 2026-09-01 | 2026-09-24 |
| Safety and Efficacy of Eculizumab in High-risk TA-TMA Eculizumab - Transplant-Associated Thrombotic Microangiopathy (TA-TMA) | Phase 2 | Recruiting | First Affiliated Hospital of Zhejiang University | 24 | 2026-07-10 | 2026-07-17 |
| Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis of IPIG-Registry Data Danicopan, Soliris/Ultomiris - Paroxysmal Nocturnal Hemoglobinuria, PNH | Active not recruiting | Alexion Pharmaceuticals, Inc. | 50 | 2026-01-14 | 2026-02-17 | |
| A Phase III Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients NTQ5082 capsules 200 mg, Eculizumab Injection - Paroxysmal Nocturnal Hemoglobinuria | Phase 3 | Not yet recruiting | Nanjing Chia-tai Tianqing Pharmaceutical | 78 | 2025-11-01 | 2025-09-17 |
| Eculizumab For the Acute Attack of Neuromyelitis Optica Spectrum Disorder Intravenous Methylprednisolone (IVMP), Complement protein C5 inhibitor - Neuromyelitis Optica Spectrum Disorder Attack | Phase 2 | Active not recruiting | Tianjin Medical University General Hospital | 110 | 2025-09-09 | 2026-06-03 |
| Eculizumab For Acute Attack of Neuromyelitis Optica Spectrum Disorder Complement protein C5 inhibitor, IVMP - Neuromyelitis Optica Spectrum Disorder Attack | Phase 2 | Withdrawn | Tianjin Medical University General Hospital | 2025-09-03 | 2025-09-10 | |
| A Phase III Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy HSK39297 tablets, Eculizumab Injection - PNH | Phase 3 | Completed | Haisco Pharmaceutical Group Co., Ltd. | 73 | 2025-02-13 | 2025-12-22 |
| Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD eculizumab - NMOSD, Neuromyelitis Optica Spectrum Disorders | Phase 3 | Active not recruiting | Alexion Pharmaceuticals, Inc. | 21 | 2025-01-16 | 2025-12-19 |
| Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG Eculizumab - Generalized Myasthenia Gravis (gMG), Refractory gMG | Phase 3 | Completed | Alexion Pharmaceuticals, Inc. | 15 | 2025-01-06 | 2026-01-15 |
| A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy HRS-5965 capsule, Eculizumab Injection - Paroxysmal Nocturnal Hemoglobinuria | Phase 3 | Completed | Chengdu Suncadia Medicine Co., Ltd. | 76 | 2024-10-25 | 2025-09-11 |
| Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy MY008211A tablets, Eculizumab Injection - Paroxysmal Nocturnal Haemoglobinuria (PNH) | Phase 3 | Recruiting | Wuhan Createrna Science and Technology Co., Ltd | 66 | 2024-08-30 | 2025-05-09 |
| Eculizumab for Prevention of Antibody-Mediated Rejection in ABO-Incompatible Living Donor Kidney Transplantation Eculizumab - Kidney Transplantation | Phase 1 / Phase 2 | Unknown | Tao Lin | 30 | 2024-07-01 | 2024-06-13 |
| Complement C5 mAb in the Treatment of Anti-GBM Disease Eculizumab - Autoimmune Diseases | Phase 2 | Completed | Peking University First Hospital | 16 | 2024-03-01 | 2025-12-05 |
| Eculizumab in Hypertensive Emergency-associated Hemolytic Uremic Syndrome Soliris®, Renin angiotensin system blockers - Hypertensive Emergency-associated Hemolytic Uremic Syndrome | Phase 3 | Recruiting | Assistance Publique - Hôpitaux de Paris | 66 | 2023-11-09 | 2024-01-05 |
| Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China Eculizumab - Atypical Hemolytic Uremic | Phase 3 | Completed | Alexion Pharmaceuticals, Inc. | 25 | 2023-07-14 | 2025-12-08 |
| Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China Eculizumab - Paroxysmal Nocturnal Hemoglobinuria | Phase 3 | Completed | Alexion Pharmaceuticals, Inc. | 25 | 2023-07-05 | 2026-06-01 |
| Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants Soliris 300 MG in 30 ML Injection, TUR03 300 MG in 30 ML Injection - Healthy | Phase 1 | Unknown | Turgut Ardika PTY LTD | 120 | 2023-04-10 | 2023-11-24 |
| Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Cemdisiran, Eculizumab, Pozelimab - Paroxysmal Nocturnal Hemoglobinuria | Phase 3 | Terminated | Regeneron Pharmaceuticals | 3 | 2022-10-06 | 2025-04-08 |
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Hemoglobinuria, Paroxysmal (35) · Atypical Hemolytic Uremic Syndrome (12) · Neuromyelitis Optica (7) · Myasthenia Gravis (5) · COVID-19 (4) · Hemolysis (4) · Anemia (3) · Delayed Graft Function (3) · Demyelinating Diseases (3) · Kidney Failure, Chronic (3) · Myelitis, Transverse (3) · Optic Neuritis (3) · Recurrence (3) · Respiratory Distress Syndrome (3) · Thrombotic Microangiopathies (3)
Alexion Pharmaceuticals, Inc. (39) · AO GENERIUM (4) · Assistance Publique - Hôpitaux de Paris (3) · Biocad (3) · Mayo Clinic (3) · National Heart, Lung, and Blood Institute (NHLBI) (3) · BioCryst Pharmaceuticals (2) · Cedars-Sinai Medical Center (2) · Hoffmann-La Roche (2) · Johns Hopkins University (2) · Regeneron Pharmaceuticals (2) · Samsung Bioepis Co., Ltd. (2) · Tianjin Medical University General Hospital (2) · Amgen (1) · Apellis Pharmaceuticals, Inc. (1)
United States (54) · United Kingdom (30) · France (26) · Germany (26) · Italy (24) · Spain (20) · Canada (17) · Japan (16) · Australia (15) · China (15) · Netherlands (14) · South Korea (13) · Sweden (13) · Russia (12) · Belgium (10)
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PMID 33783815, PMID 23738544, PMID 30905021, PMID 32189108, PMID 32426038, PMID 32700461, PMID 33229455, PMID 33329303, PMID 33676197, PMID 34498507, PMID 34526067, PMID 34590717, PMID 39535306, PMID 40978458, PMID 16990386, PMID 17702897, PMID 18055865, PMID 20230403, PMID 21222185, PMID 21877169, PMID 21942930, PMID 22403278, PMID 23512355, PMID 23623397, PMID 23934275, PMID 24289920, PMID 24354307, PMID 24408973, PMID 24990476, PMID 25654478, PMID 25833956, PMID 27568864, PMID 27801990, PMID 27821382, PMID 29066163, PMID 29685815, PMID 30291112, PMID 30767274, PMID 30887675, PMID 31050279, PMID 31115842, PMID 31698177, PMID 31949012, PMID 32086819, PMID 32869125, PMID 32990324, PMID 33178408, PMID 33251691, PMID 33270832, PMID 33310418
2016 (4), 2019 (4), 2023 (3), 2009 (2), 2014 (2), 2015 (1), 2025 (1), K12HD085845 (1), P01DK058335 (1), UL1TR000135 (1), ZIAAI000717-22 (1)