Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 26 |
| INN | Eculizumab |
| Status | Approved |
| Drug code(s) | AX451, H5G1.1 |
| Brand name | Soliris |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2/4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Complement C5 |
| Indications of clinical studies | Membranous Nephritis, Rheumatoid Arthritis, Lupus, Psoriasis, Dermatomyositis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, China, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 24, 1997 |
| Start of Phase 2 | August 15, 1999 |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | September 15, 2006 |
| Year of first approval (global) | 2007 |
| Date of first US approval | March 16, 2007 |
| INN, US product name | Eculizumab |
| US or EU approved indications | Paroxysmal Nocturnal Hemoglobinuria, Myasthenia Gravis, Hemolytic Uremic Syndrome. Aug 2019: European Commission (EC) has approved the extension of the current marketing authorization of SOLIRIS® (eculizumab) to include the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease. The U.S. Food and Drug Administration (FDA) approved SOLIRIS for the treatment of NMOSD in adult patients who are AQP4 antibody-positive on June 27, 2019. |
| Company | AstraZeneca |
| Licensee/Partner | None |
| Comments about company or candidate | AstraZeneca acquired Alexion (formerly Syntimmune) in 2021. |
| Full address of company | Cambridge, United Kingdom Europe United Kingdom https://www.astrazeneca.com/our-company/contact-us.html |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |