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
- -
Vascular Effects of Alirocumab in Acute MI-Patients
- Conditions
- Interventions
- First Posted Date
- 2017-03-01
- Last Posted Date
- 2022-02-24
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Target Recruit Count
- 294
- Registration Number
- NCT03067844
- Locations
- 🇨🇭
Basel University Hospital, Basel, Switzerland
🇨🇭Hopitaux Universitaires Geneve, Geneva, Switzerland
🇨🇭University Hospital Zurich USZ, Zürich, Switzerland
Alirocumab and Reverse Cholesterol Transport
- Conditions
- Interventions
- First Posted Date
- 2017-01-09
- Last Posted Date
- 2018-11-07
- Lead Sponsor
- Washington University School of Medicine
- Target Recruit Count
- 28
- Registration Number
- NCT03014830
- Locations
- 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome
- Conditions
- Interventions
- First Posted Date
- 2016-12-28
- Last Posted Date
- 2022-08-19
- Lead Sponsor
- Gloria Vega
- Target Recruit Count
- 3
- Registration Number
- NCT03004001
- Locations
- 🇺🇸
DallasVAMC, Dallas, Texas, United States
Assessment of Atherosclerotic Plaque Characteristics Change by DCE-MRI With Alirocumab
- First Posted Date
- 2016-12-14
- Last Posted Date
- 2019-04-26
- Lead Sponsor
- Westside Medical Associates of Los Angeles
- Target Recruit Count
- 35
- Registration Number
- NCT02992301
- Locations
- 🇺🇸
Westside Medical Associates of Los Angeles, Beverly Hills, California, United States
A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease
- Conditions
- Interventions
- First Posted Date
- 2016-11-08
- Last Posted Date
- 2023-05-10
- Lead Sponsor
- University of Virginia
- Target Recruit Count
- 40
- Registration Number
- NCT02959047
- Locations
- 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸University of Virginia Health System, Charlottesville, Virginia, United States
Alirocumab in Patients With Acute Myocardial Infarction
- Conditions
- Interventions
- First Posted Date
- 2016-10-19
- Last Posted Date
- 2019-09-06
- Lead Sponsor
- Virginia Commonwealth University
- Target Recruit Count
- 20
- Registration Number
- NCT02938949
- Locations
- 🇺🇸
Virginia Commonwealth University, Richmond, Virginia, United States
Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia
- First Posted Date
- 2016-03-22
- Last Posted Date
- 2019-09-30
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 615
- Registration Number
- NCT02715726
- Locations
- 🇨🇳
Investigational Site Number 1560018, Beijing, China
🇨🇳Investigational Site Number 1560008, Hangzhou, China
🇨🇳Investigational Site Number 1560009, Shenyang, China
Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)
- Conditions
- Interventions
- First Posted Date
- 2015-12-30
- Last Posted Date
- 2018-05-01
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 413
- Registration Number
- NCT02642159
- Locations
- 🇺🇸
Investigational Site Number 840-156, Tustin, California, United States
🇫🇮Investigational Site Number 246101, Oulu, Finland
🇺🇸Investigational Site Number 840-118, Los Angeles, California, United States
Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)
- Conditions
- Interventions
- First Posted Date
- 2015-10-23
- Last Posted Date
- 2018-05-17
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 517
- Registration Number
- NCT02585778
- Locations
- 🇺🇸
Investigational Site Number 840020, Encino, California, United States
🇺🇸Investigational Site Number 840027, Loveland, Colorado, United States
🇺🇸Investigational Site Number 840029, Oakland, California, United States
Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin
- Conditions
- Interventions
- First Posted Date
- 2015-10-22
- Last Posted Date
- 2019-01-23
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 163
- Registration Number
- NCT02584504
- Locations
- 🇯🇵
Investigational Site Number 392004, Kawanishi-Shi, Japan
🇯🇵Investigational Site Number 392016, Shinagawa-Ku, Japan
🇯🇵Investigational Site Number 392029, Chuo-Ku, Japan
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.