Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 124 |
| INN | Alirocumab |
| Status | Approved |
| Drug code(s) | REGN727, SAR236553 |
| Brand name | Praluent |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (Velocimmune) |
| Target(s) | PCSK9 |
| Indications of clinical studies | High cholesterol |
| Primary therapeutic area | Metabolic disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2009 |
| Start of Phase 2 | |
| Start of Phase 3 | July 15, 2012 |
| Date BLA/NDA submitted to FDA | November 24, 2014 |
| Year of first approval (global) | 2015 |
| Date of first US approval | July 24, 2015 |
| INN, US product name | Alirocumab |
| US or EU approved indications | High cholesterol (treatment of adults with high low-density lipoprotein (LDL) cholesterol); reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease. |
| Company | Regeneron Pharmaceuticals |
| Licensee/Partner | None |
| Comments about company or candidate | None |
| Full address of company | Tarrytown, New York, United States North America United States of America https://www.regeneron.com/ |
Lowers low-density lipoprotein (LDL) cholesterol by targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), an enzyme which binds LDL receptors, leading to their accelerated degradation and increased LDL-cholesterol (LDL-C) levels
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |