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
- -
Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects
- Conditions
- Interventions
- First Posted Date
- 2012-11-08
- Last Posted Date
- 2016-09-28
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 79
- Registration Number
- NCT01723735
- Locations
- 🇫🇷
Investigational Site Number 250001, Rennes, France
🇫🇷Investigational Site Number 250002, Rueil Malmaison, France
Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)
- Conditions
- Interventions
- First Posted Date
- 2012-10-18
- Last Posted Date
- 2015-10-28
- Lead Sponsor
- Regeneron Pharmaceuticals
- Target Recruit Count
- 249
- Registration Number
- NCT01709500
Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
- Conditions
- Interventions
- First Posted Date
- 2012-10-18
- Last Posted Date
- 2020-06-23
- Lead Sponsor
- Regeneron Pharmaceuticals
- Target Recruit Count
- 314
- Registration Number
- NCT01709513
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
- Conditions
- Interventions
- First Posted Date
- 2012-08-13
- Last Posted Date
- 2019-03-18
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 18924
- Registration Number
- NCT01663402
- Locations
- 🇺🇸
Investigational Site Number 840075, Atlanta, Georgia, United States
🇺🇸Investigational Site Number 840231, Philadelphia, Pennsylvania, United States
🇺🇸Investigational Site Number 840339, Philadelphia, Pennsylvania, United States
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia
- Conditions
- Interventions
- First Posted Date
- 2012-07-19
- Last Posted Date
- 2015-11-06
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 103
- Registration Number
- NCT01644474
- Locations
- 🇺🇸
Investigational Site Number 840603, Overland Park, Kansas, United States
🇺🇸Investigational Site Number 840601, Cincinnati, Ohio, United States
🇳🇱Investigational Site Number 528602, Groningen, Netherlands
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)
- Conditions
- Interventions
- First Posted Date
- 2012-07-18
- Last Posted Date
- 2015-11-06
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 316
- Registration Number
- NCT01644175
- Locations
- 🇺🇸
Investigational Site Number 840827, Mt. Pleasant, South Carolina, United States
🇺🇸Investigational Site Number 840832, Southfield, Michigan, United States
🇺🇸Investigational Site Number 840891, Mobile, Alabama, United States
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
- Conditions
- Interventions
- First Posted Date
- 2012-07-18
- Last Posted Date
- 2016-08-04
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 720
- Registration Number
- NCT01644188
- Locations
- 🇺🇸
Investigational Site Number 840979, Los Angeles, California, United States
🇺🇸Investigational Site Number 840966, Fall River, Massachusetts, United States
🇺🇸Investigational Site Number 840946, Butte, Montana, United States
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
- Conditions
- Interventions
- First Posted Date
- 2012-06-19
- Last Posted Date
- 2016-02-08
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 486
- Registration Number
- NCT01623115
- Locations
- 🇺🇸
Investigational Site Number 840421, Mission Viejo, California, United States
🇺🇸Investigational Site Number 840452, Washington, District of Columbia, United States
🇺🇸Investigational Site Number 840425, Auburn, Maine, United States
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)
- Conditions
- Interventions
- First Posted Date
- 2012-06-12
- Last Posted Date
- 2016-10-04
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 107
- Registration Number
- NCT01617655
- Locations
- 🇺🇸
Investigational Site Number 840742, Bell Gardens, California, United States
🇺🇸Investigational Site Number 840743, Northridge, California, United States
🇺🇸Investigational Site Number 840710, Ponte Vedra, Florida, United States
A Study of Alirocumab in Participants With Autosomal Dominant Hypercholesterolemia (ADH) and Gain-of-Function Mutations (GOFm) of the Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Gene or Loss-of-Function Mutations (LOFm) of the Apolipoprotein (Apo) B Gene
- First Posted Date
- 2012-05-24
- Last Posted Date
- 2020-06-17
- Lead Sponsor
- Regeneron Pharmaceuticals
- Target Recruit Count
- 23
- Registration Number
- NCT01604824
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.