Alirocumab
- Generic Name
- Alirocumab
- Brand Names
- Praluent
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1245916-14-6
- Unique Ingredient Identifier
- PP0SHH6V16
- Background
Alirocumab is a biopharmaceutical that obtained FDA approval in July 2015 as a second line treatment for high cholesterol in adults whose LDL-cholesterol (LDL-C) is not controlled by the combination of diet and statin treatment. It is a human monoclonal antibody part of the family of the PCSK9 inhibitors which are a novel class of anticholesterol therapeutic...
- Indication
Alirocumab is an antibody eliciting proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor activity that is indicated for:
(i) use in reducing the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease , and/or
...
- Associated Conditions
- Heterozygous Familial Hypercholesterolemia (HeFH), Homozygous Familial Hypercholesterolaemia (HoFH), Myocardial Infarction, Stroke, Unstable Angina Pectoris, Primary Hyperlipidemia
- Associated Therapies
- -
Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
- Conditions
- Interventions
- First Posted Date
- 2012-04-12
- Last Posted Date
- 2020-08-05
- Lead Sponsor
- Regeneron Pharmaceuticals
- Target Recruit Count
- 58
- Registration Number
- NCT01576484
Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)
- Conditions
- Interventions
- First Posted Date
- 2012-01-11
- Last Posted Date
- 2015-12-22
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 2341
- Registration Number
- NCT01507831
- Locations
- 🇺🇸
Investigational Site Number 840047, Houston, Texas, United States
🇺🇸Investigational Site Number 840076, Long Beach, California, United States
🇺🇸Investigational Site Number 840163, Santa Rosa, California, United States
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy
- Conditions
- Interventions
- First Posted Date
- 2011-02-02
- Last Posted Date
- 2015-09-24
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 183
- Registration Number
- NCT01288443
- Locations
- 🇺🇸
Investigational Site Number 840525, Tempe, Arizona, United States
🇺🇸Investigational Site Number 840521, Bristol, Tennessee, United States
🇺🇸Investigational Site Number 840516, Los Angeles, California, United States
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
- Conditions
- Interventions
- First Posted Date
- 2011-02-02
- Last Posted Date
- 2015-09-24
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 92
- Registration Number
- NCT01288469
- Locations
- 🇺🇸
Investigational Site Number 840619, Chicago, Illinois, United States
🇺🇸Investigational Site Number 840621, Richmond, Virginia, United States
🇺🇸Investigational Site Number 840602, Eugene, Oregon, United States
Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia
- First Posted Date
- 2010-12-24
- Last Posted Date
- 2015-09-22
- Lead Sponsor
- Regeneron Pharmaceuticals
- Target Recruit Count
- 77
- Registration Number
- NCT01266876
Drug Development Updates
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