alirocumab
Trade name: praluent
mAbapproved
Approved
Jul 24, 2015
Alirocumab, sold under the brand name Praluent, is a medication used as a second-line treatment for high cholesterol for adults whose cholesterol is not controlled by diet and statin treatment. It is a human monoclonal antibody that belongs to a novel class of anti-cholesterol drugs, known as PCSK9 inhibitors, and it was the first such agent to receive FDA approval. The FDA approval was contingent on the completion of further clinical trials to better determine efficacy and safety. — Wikipedia
Clinical trial activity
89 trials · 47 clinical orgs · 2 marketing orgs
Phase 1
18
Phase 2
47
Phase 3
33
Phase 4
18
Earliest trial started Nov 1, 2009 (NCT01026597)
Timeline
2010s
- Jan 1, 2011
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2012
Earliest Phase 3 Sponsor(trial)
- Jul 24, 2015
Sanofi-Aventis — Earliest FDA Approval
- Jul 24, 2015
Regeneron — Marketing Organization
- Jul 24, 2015
Sanofi-Aventis — Marketing Organization
- Jul 24, 2015
Sanofi-Aventis — NDA Organization
- Jul 24, 2015
Regeneron — NDA Secondary Org
Indications
Studied for
- Acute Coronary Syndrome · Phase 4
- Alcohol Drinking · Phase 1
- Alcohol-Induced Disorders · Phase 1
- Anemia, Aplastic · Phase 1/Phase 2
- Angina Pectoris · Phase 4
- Aortic Valve Stenosis · Phase 3
- Atherosclerosis · Phase 4
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Cardiovascular Diseases · Phase 3
- Constriction, Pathologic · Phase 3
- Coronary Artery Disease · Phase 4
- Coronary Circulation · Phase 3
- Coronary Disease · Phase 1
- Coronary Vessels · Phase 3
- Diabetes Mellitus, Type 2 · Phase 3
- Dyslipidemias · Phase 4
- Healthy Volunteers · Phase 1
- Hemorrhage · Early Phase 1
- HIV Infections · Phase 3
- Homozygous Familial Hypercholesterolemia · Phase 4
- Hypercholesterolemia · Phase 4
- Hyperlipidemias · Phase 4
- Hypertrophy, Left Ventricular · Phase 4
- Inflammation · Phase 4
- Intracranial Arteriosclerosis · Phase 3
- Ischemic Stroke · Phase 4
- Livedoid Vasculopathy · Phase 4
- Myocardial Infarction · Phase 4
- Myocardium · Phase 3
- PCSK9 Inhibitors · Phase 4
- Peripheral Arterial Disease · Phase 4
- Peritoneal Dialysis · Phase 3
- Pharmacokinetics · Phase 1
- Physiological Effects of Drugs · Phase 2
- Plaque, Atherosclerotic · Phase 3
- Renal Dialysis · Phase 3
- Sepsis · Phase 2/Phase 3
- Shock, Septic · Phase 2/Phase 3
- ST Elevation Myocardial Infarction · Phase 2
- Stroke · Early Phase 1
Mechanism of action
- Subtilisin/kexin type 9INHIBITOR
PCSK9 inhibitor
Approval history
- approvedJul 24, 2015
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- WikipediaAlirocumab ↗
- NCATSPP0SHH6V16 ↗
- ChEMBLCHEMBL2109540 ↗
Also known as
- alirocumab
- alirocumab
- alirocumab
- alirocumab
- alirocumab
- alirocumab
- alirocumab
- alirocumab
- alirocumab
- alirocumab
- monoclonal antibody regn727
- praluent
- praluent
- praluent
- praluent
- praluent
- regn727
- regn727
- regn-727
- regn727 monoclonal antibody
- sar236553
- sar236553
- sar-236553
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06385262 | Phase 2 | Nov 1, 2024 | Duke University, Regeneron |
| NCT05587621 | N/A | Apr 1, 2024 | Friedrich Schiller University, University of Jena |
| NCT06080256 | Phase 3 | Dec 30, 2023 | Nanjing Medical University |
| NCT06083961 | Phase 4 | Oct 15, 2023 | University of Ulsan |
| NCT05553834 | Phase 2 | Jan 1, 2023 | Duke University, Regeneron |
| NCT05292404 | Phase 4 | Oct 1, 2022 | Jiao Tong University |
| NCT05469347 | Phase 1 | Sep 30, 2022 | Emory University, Regeneron |
| NCT05043740 | N/A | Oct 31, 2021 | Central South University |
| NCT04781322 | Phase 1 | Oct 19, 2021 | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| NCT04968509 | Phase 3 | Aug 1, 2021 | Capital Medical University |
| NCT05001984 | Phase 2 | Aug 1, 2021 | Chang Gung University |
| NCT04790513 | Phase 3 | Apr 22, 2021 | LIB Therapeutics LLC |
| NCT04731155 | Phase 4 | Feb 1, 2021 | Jiao Tong University |
| NCT04613167 | N/A | Nov 10, 2020 | University of Ljubljana |
| NCT04409080 | Phase 1/Phase 2 (Phase 2) | Aug 21, 2020 | Regeneron |
| NCT04189484 | Phase 1 | Feb 29, 2020 | Food and Drug Administration, Spaulding Clinical Research Inc. |
| NCT03750760 | Phase 4 | Jan 31, 2020 | Harvard University, Imperial College London, Regeneron |
| NCT04193306 | Phase 4 | Nov 18, 2019 | Charles University, Masaryk University |
| NCT04073797 | N/A | Oct 1, 2019 | University of Cambridge, Wellcome Trust |
| NCT03718286 | Phase 2 | Mar 11, 2019 | McMaster University |
Showing 20 of 89 trials
Page 1 / 5
Organizations
Research & Development (47)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Regeneron | For profit | 61 | 17 | 5 | 2009 |
| Sanofi | For profit | 50 | 33 | 4 | 2009 |
| Capital Medical University | Academic/Hospital | 2 | 2 | 2 | 2019 |
| Duke University | Academic/Hospital | 2 | 2 | 1 | 2023 |
| Harvard University | Academic/Hospital | 2 | 0 | 2 | 2017 |
| Jiao Tong University | Academic/Hospital | 2 | 2 | 1 | 2021 |
| Kobe University | Academic/Hospital | 2 | 2 | 1 | 2017 |
| University of Cambridge | Academic/Hospital | 2 | 2 | 1 | 2017 |
| Aventis | For profit | 1 | 0 | 1 | 2017 |
| Baylor University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Central South University | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Chang Gung University | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Charles University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Dallas VA Medical Center | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Department of Veteran Affairs | Government | 1 | 0 | 1 | 2017 |
| Emory University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Food and Drug Administration | Government | 1 | 1 | 1 | 2020 |
| Friedrich Schiller University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Fundación Hipercolesterolemia Familiar | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Hebrew University | Academic/Hospital | 1 | 0 | 1 | 2019 |
47 organizations
Page 1 / 3
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Regeneron | For profit | MKTG | Jul 24, 2015 |
| Regeneron | For profit | NDA2 | Jul 24, 2015 |
| Sanofi-Aventis | For profit | MKTG | Jul 24, 2015 |
| Sanofi-Aventis | For profit | NDA | Jul 24, 2015 |