Eculizumab
- Generic Name
- Eculizumab
- Brand Names
- Soliris, Epysqli, Bekemv
- Drug Type
- Biotech
- CAS Number
- 219685-50-4
- Unique Ingredient Identifier
- A3ULP0F556
- Background
Eculizumab is a monoclonal antibody that targets complement protein C5. Binding to this protein prevents the activation of a complement terminal complex, which is used to treat a number of autoimmune conditions.
Eculizumab was granted FDA approval on 16 March 2007. In Q1 2023, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of two formulations of eculizumab indicated for the treatment of paroxysmal nocturnal hemoglobinuria.
- Indication
Eculizumab is indicated in the US to treat paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy, and neuromyelitis optica spectrum disorder (NMOSD). It is also indicated in EU to treat PNH in both adult and pediatric patients.
- Associated Conditions
- Generalized Myasthenia Gravis, Neuromyelitis Optica Spectrum Disorders, Paroxysmal Nocturnal Haemoglobinuria (PNH), Thrombotic Microangiopathies
Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Interventions
- First Posted Date
- 2020-09-22
- Last Posted Date
- 2024-10-09
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 97
- Registration Number
- NCT04558918
- Locations
- 🇺🇸
City Of Hope National Med Center City of Hope Medical Center, Duarte, California, United States
🇺🇸Augusta University Georgia Patient Treatment, Augusta, Georgia, United States
🇺🇸Univ Cali Irvine ALS Neuromuscular, Orange, California, United States
A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Interventions
- First Posted Date
- 2020-06-16
- Last Posted Date
- 2025-05-01
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 204
- Registration Number
- NCT04434092
- Locations
- 🇵🇱
MTZ Clinical Research Powered by Pratia, Warszawa, Poland
🇫🇷Centre Hospitalier Lyon Sud, Pierre-Bénite, France
🇩🇪Universitaetsklinikum Ulm, Ulm, Germany
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Interventions
- First Posted Date
- 2020-06-16
- Last Posted Date
- 2025-05-04
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 190
- Registration Number
- NCT04432584
- Locations
- 🇬🇷
Attikon University General Hospital, Athens, Greece
🇪🇸Hospital Universitari Vall d'Hebron, Barcelona, Spain
🇪🇸Hospital Universitario de Gran Canaria, Las Palmas, Spain
CORIMUNO19-ECU: Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID-19 Infection, Nested in the CORIMUNO-19 Cohort
- First Posted Date
- 2020-04-15
- Last Posted Date
- 2020-04-27
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Target Recruit Count
- 120
- Registration Number
- NCT04346797
- Locations
- 🇫🇷
Réanimation médicale, Paris, France
🇫🇷Saint Louis, Paris, Ile De France, France
🇫🇷saint Louis, Paris, France
Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Interventions
- First Posted Date
- 2020-03-25
- Last Posted Date
- 2024-08-12
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Target Recruit Count
- 18
- Registration Number
- NCT04320602
- Locations
- 🇬🇧
Clinical Study Site, London, United Kingdom
🇬🇧Research Site, London, United Kingdom
Eculizumab (Soliris) in Covid-19 Infected Patients
- Conditions
- Coronavirus
- First Posted Date
- 2020-02-28
- Last Posted Date
- 2020-03-30
- Lead Sponsor
- Hudson Medical
- Registration Number
- NCT04288713
A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder
- Conditions
- Neuromyelitis Optica Spectrum DisorderNeuromyelitis Optica
- Interventions
- First Posted Date
- 2019-11-07
- Last Posted Date
- 2024-05-06
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Target Recruit Count
- 5
- Registration Number
- NCT04155424
- Locations
- 🇪🇸
Clinical Trial Site, Sevilla, Spain
🇪🇸Research Site, Esplugues de Llobregat, Spain
The Use of Eculizumab in HELLP Syndrome
- Conditions
- Complement AbnormalityMorbidity;NewbornPreeclampsia SevereHELLP Syndrome (HELLP), Third TrimesterMaternal Injury
- Interventions
- First Posted Date
- 2019-09-25
- Last Posted Date
- 2023-11-14
- Lead Sponsor
- Johns Hopkins University
- Target Recruit Count
- 3
- Registration Number
- NCT04103489
- Locations
- 🇺🇸
The Johns Hopkins University, Baltimore, Maryland, United States
A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Interventions
- Drug: SB12 (proposed eculizumab biosimilar)
- First Posted Date
- 2019-08-15
- Last Posted Date
- 2024-03-26
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Target Recruit Count
- 50
- Registration Number
- NCT04058158
- Locations
- 🇮🇳
Fortis Memorial Research Institute, Gurgaon, Haryana, India
🇲🇾Hospital Sultanah Aminah, Johor Bahru, Malaysia
🇲🇾Hospital Pulau Pinang, Pulau Pinang, Malaysia
Transcriptome and Metabolic Analyses of CHAPLE Disease
- Conditions
- Complement Regulatory Factor DefectCD55 - Cluster of Differentiation Antigen 55 DeficiencyPrimary Intestinal LymphangiectasisProtein-Losing Enteropathies
- Interventions
- First Posted Date
- 2019-05-15
- Last Posted Date
- 2019-08-14
- Lead Sponsor
- Marmara University
- Target Recruit Count
- 60
- Registration Number
- NCT03950804
- Locations
- 🇹🇷
Marmara University, Istanbul, Turkey
Drug Development Updates
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