Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 162 |
| INN | Belimumab |
| Status | Approved |
| Drug code(s) | GSK1550188, HGS-1006, LSB, LymphoStat-B |
| Brand name | Benlysta |
| 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 | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Phage display (CAT library) |
| Target(s) | BAFF |
| Indications of clinical studies | Systemic Lupus Erythematosus, rheumatoid arthritis, Sjögren's Syndrome, Symptomatic Waldenstroms Macroglobulinaemia, Normalization of Alloantibody Levels in Sensitized Patients Awaiting Kidney Transplantation |
| 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) | November 15, 2001 |
| Start of Phase 2 | September 25, 2003 |
| Start of Phase 3 | December 15, 2006 |
| Date BLA/NDA submitted to FDA | June 09, 2010 |
| Year of first approval (global) | 2011 |
| Date of first US approval | March 09, 2011 |
| INN, US product name | Belimumab |
| US or EU approved indications | Systemic Lupus Erythematosus |
| Company | GlaxoSmithKline |
| Licensee/Partner | None |
| Comments about company or candidate | Fast track; GlaxoSmithKline acquired Human Genome Sciences in 2012. |
| Full address of company | 980 Great West Road Brentford Middlesex, TW8 9GS, United Kingdom Europe United Kingdom https://www.gsk.com/en-gb/contact-us/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |