Entry ID | 2221 |
INN | Tabalumab |
Status | Terminated |
Drug code(s) | LY-2127399 |
Brand name | None |
mAb sequence source | mAb human |
General Molecular Category | Naked monospecific |
Format, general category | Full length Ab |
Format details | None |
Isotype (Fc) | IgG4 |
Light chain isotype | kappa |
Linker | None |
Ave. DAR | None |
Conjugated/fused moiety | None |
Discovery method/technology | Transgenic mouse |
Target(s) | BAFF |
Indications of clinical studies | Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Myeloma, Multiple Sclerosis, Kidney Failure, Chronic |
Primary therapeutic area | Immune-mediated / inflammatory disorders |
Most advanced stage of development (global) | Terminated at Phase 3 |
Status | Inactive |
Start of clinical phase (IND filing or first Phase 1) | January 01, 2004 |
Start of Phase 2 | March 15, 2006 |
Start of Phase 3 | December 15, 2010 |
Date BLA/NDA submitted to FDA | |
Year of first approval (global) | None |
Date of first US approval | |
INN, US product name | None |
US or EU approved indications | None |
Company | Eli Lilly and Company |
Licensee/Partner | None |
Comments about company or candidate | Studies in RA terminated in 2013; studies in lupus terminated in Oct 2014. Phase 1 study results published in Br J Clin Pharmacol. 2016 May; 81(5): 908–917. The initial phase 1 study of tabalumab included patients both with RA and SLE, as it was felt that tabalumab could be effective in both populations. Date of first phase 1 estimated. |
Full address of company | Indianapolis, Indiana, United States North America United States of America https://www.lilly.com/contact-us |
B-cell activating factor (BAFF) is also known as tumor necrosis factor ligand superfamily member 13B and B cell activating factor (aka BLyS)
Anticipated events | None |
Factor(s) contributing to discontinuation | None |