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
Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria
- Conditions
- Paroxysmal Hemoglobinuria, Nocturnal
- First Posted Date
- 2005-08-12
- Last Posted Date
- 2017-07-02
- Target Recruit Count
- 87
- Registration Number
- NCT00130000
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States
Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)
- First Posted Date
- 2005-07-22
- Last Posted Date
- 2018-03-13
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Target Recruit Count
- 187
- Registration Number
- NCT00122317
- Locations
- 🇺🇸
Hartford Hospital, Cancer Clinical Research Office, Hartford, Connecticut, United States
🇺🇸Cleveland Clinic Foundation, Cleveland, Ohio, United States
🇦🇺The Royal Perth Hospital, Department of Haematology/Level 2, Perth, Western Australia, Australia
Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients
- Conditions
- Hemoglobinuria, Paroxysmal
- First Posted Date
- 2005-07-22
- Last Posted Date
- 2006-12-04
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Target Recruit Count
- 75
- Registration Number
- NCT00122330
- Locations
- 🇺🇸
University of California at Los Angeles, Los Angeles, California, United States
🇺🇸Washington University School of Medicine, Dept. of Internal Medicine/Division of Hematology, St. Louis, Missouri, United States
🇺🇸Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program, Philadelphia, Pennsylvania, United States
Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab
- Conditions
- Hemoglobinuria, Paroxysmal
- First Posted Date
- 2005-07-22
- Last Posted Date
- 2007-02-21
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Target Recruit Count
- 85
- Registration Number
- NCT00122304
- Locations
- 🇺🇸
NYU Clinical Cancer Center, New York, New York, United States
🇺🇸Johns Hopkins University Medical Center, Baltimore, Maryland, United States
🇺🇸Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program, Philadelphia, Pennsylvania, United States
Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria
- Conditions
- Hemoglobinuria, Paroxysmal
- First Posted Date
- 2004-12-06
- Last Posted Date
- 2008-03-04
- Target Recruit Count
- 75
- Registration Number
- NCT00098280
- Locations
- 🇺🇸
National Heart, Lung and Blood Institute (NHLBI), Bethesda, Maryland, United States
Drug Development Updates
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