Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 9 |
| INN | Canakinumab |
| Status | Approved |
| Drug code(s) | ACZ885 |
| Brand name | Ilaris |
| 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 (GenPharm/Medarex/BMS transgenic mouse platform Ultimab) |
| Target(s) | IL-1 beta |
| Indications of clinical studies | COVID-19, Cryopyrin-Associated Periodic Syndromes, Rheumatoid arthritis, wet age-related macular degeneration, Atherosclerosis and Either T2DM or IGT, Type 2 Diabetes, gout, juvenile arthritis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 15, 2003 |
| Start of Phase 2 | August 15, 2005 |
| Start of Phase 3 | July 15, 2007 |
| Date BLA/NDA submitted to FDA | December 17, 2008 |
| Year of first approval (global) | 2009 |
| Date of first US approval | June 17, 2009 |
| INN, US product name | Canakinumab |
| US or EU approved indications | Adult-onset Still's disease, Juvenile Rheumatoid Arthritis, Cryopyrin (CIAS1)-Associated Periodic Syndromes, Tumor Necrosis Factor Receptor-Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome / Mevalonate Kinase Deficiency, Familial Mediterranean Fever in combination with colchicine |
| Company | Novartis Pharmaceuticals |
| Licensee/Partner | None |
| Comments about company or candidate | US orphan |
| Full address of company | Basel, Switzerland Europe Switzerland https://www.novartis.com/contacts |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |