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By inhibiting this pathway, eculizumab reduces complement-mediated hemolysis and tissue damage in complement-driven diseases.","oneSentence":"Eculizumab is a monoclonal antibody that inhibits the complement protein C5, blocking the formation of the membrane attack complex and reducing complement-mediated cell destruction.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:10:33.136Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Paroxysmal nocturnal hemoglobinuria (PNH)"},{"name":"Atypical hemolytic uremic syndrome (aHUS)"},{"name":"Generalized myasthenia gravis (gMG)"},{"name":"Neuromyelitis optica spectrum disorder (NMOSD)"}]},"trialDetails":[{"nctId":"NCT07410039","phase":"PHASE4","title":"Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study","status":"RECRUITING","sponsor":"Chinese PLA General Hospital","startDate":"2026-02-01","conditions":"Neuromyelitis Optica Spectrum Disorder Attack","enrollment":200},{"nctId":"NCT04434092","phase":"PHASE3","title":"A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2020-10-08","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":210},{"nctId":"NCT06799546","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2025-02-13","conditions":"PNH","enrollment":73},{"nctId":"NCT07177859","phase":"PHASE3","title":"A Phase III Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients","status":"NOT_YET_RECRUITING","sponsor":"Nanjing Chia-tai Tianqing Pharmaceutical","startDate":"2025-11","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":78},{"nctId":"NCT06593938","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"Chengdu Suncadia Medicine Co., Ltd.","startDate":"2024-10-25","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":76},{"nctId":"NCT04935177","phase":"PHASE3","title":"Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx","status":"COMPLETED","sponsor":"Hansa Biopharma AB","startDate":"2021-10-14","conditions":"Kidney Transplantation in Highly Sensitized Patients","enrollment":64},{"nctId":"NCT06932744","phase":"PHASE3","title":"Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy","status":"RECRUITING","sponsor":"Wuhan Createrna Science and Technology Co., Ltd","startDate":"2024-08-30","conditions":"Paroxysmal Nocturnal Haemoglobinuria (PNH)","enrollment":66},{"nctId":"NCT02714374","phase":"PHASE1","title":"GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers","status":"TERMINATED","sponsor":"Andrew Lowy","startDate":"2016-03-25","conditions":"Solid Organ Cancers","enrollment":5},{"nctId":"NCT05863442","phase":"PHASE1","title":"Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants","status":"UNKNOWN","sponsor":"Turgut Ardika PTY LTD","startDate":"2023-04-10","conditions":"Healthy","enrollment":120},{"nctId":"NCT02591862","phase":"PHASE2","title":"Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH)","status":"COMPLETED","sponsor":"AKARI Therapeutics","startDate":"2016-02","conditions":"Paroxysmal Nocturnal Haemoglobinuria (PNH)","enrollment":1},{"nctId":"NCT03722329","phase":"PHASE1","title":"Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects","status":"COMPLETED","sponsor":"Samsung Bioepis Co., Ltd.","startDate":"2018-11-13","conditions":"Healthy","enrollment":240},{"nctId":"NCT03950804","phase":"","title":"Transcriptome and Metabolic Analyses of CHAPLE Disease","status":"UNKNOWN","sponsor":"Marmara University","startDate":"2018-06-15","conditions":"CD55 - Cluster of Differentiation Antigen 55 Deficiency, Primary Intestinal Lymphangiectasis, Protein-Losing Enteropathies","enrollment":60},{"nctId":"NCT02205541","phase":"PHASE3","title":"Eculizumab in Shiga-toxin Related Hemolytic and Uremic Syndrome Pediatric Patients - ECULISHU","status":"COMPLETED","sponsor":"University Hospital, Toulouse","startDate":"2015-06","conditions":"Hemolytic Uremic Syndrome of Childhood","enrollment":100}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":28,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Soliris"],"phase":"phase_3","status":"active","brandName":"Eculizumab Injection","genericName":"Eculizumab Injection","companyName":"Wuhan Createrna Science and Technology Co., Ltd","companyId":"wuhan-createrna-science-and-technology-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Eculizumab is a monoclonal antibody that inhibits the complement protein C5, blocking 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).","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2007-03-16T00:00:00.000Z","mah":"ALEXION PHARM","brand_name_local":"SOLIRIS","application_number":"BLA125166"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2007-06-20T00:00:00.000Z","mah":"Alexion Europe SAS","brand_name_local":"Soliris","application_number":"EMEA/H/C/000791"}],"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}