Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 94 |
| INN | Ixekizumab |
| Status | Approved |
| Drug code(s) | LY2439821 |
| Brand name | Taltz, Torutsu (Japan) |
| mAb sequence source | mAb humanized |
| 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 | Phage display library derived from mouse |
| Target(s) | IL-17A |
| Indications of clinical studies | Psoriatic arthritis, Rheumatoid Arthritis, Psoriasis |
| 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 06, 2006 |
| Start of Phase 2 | |
| Start of Phase 3 | November 15, 2011 |
| Date BLA/NDA submitted to FDA | March 23, 2015 |
| Year of first approval (global) | 2016 |
| Date of first US approval | March 22, 2016 |
| INN, US product name | Ixekizumab |
| US or EU approved indications | Psoriasis (treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy), Psoriatic Arthritis. Aug 2019 FDA has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). This is the third indication for Taltz, which was first approved by the FDA in March 2016 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and then approved by the FDA in December 2017 for the treatment of adults with active psoriatic arthritis. |
| Company | Eli Lilly and Company |
| Licensee/Partner | None |
| Comments about company or candidate | None |
| Full address of company | Indianapolis, Indiana, United States North America United States of America https://www.lilly.com/contact-us |
S228P stabilization. Mice were immunized with carrier-free recombinant human IL-17A (R&D Systems, Minneapolis, MN, USA), and splenic B-cells were isolated to generate a fragment antigen-binding (Fab)-expressing phage display library using standard DNA techniques. Recombinant Fabs were screened for binding and neutralization of human IL-17A. The Fab genes were sequenced, and a subset was expressed, purified, and characterized for their affinity, selectivity, and neutralization. None of the Fabs bound to mouse or rat IL-17A. Four Fabs were converted to chimeric monoclonal antibodies (mAbs) using the human IgG4 backbone and further tested for selectivity, cell-based neutralization, affinity, and binding to human and cynomolgus monkey IL-17A. Clone 2321 was chosen for humanization and optimization; the detailed methods are described in the Supplementary materials. Liu L, Lu J, Allan BW, Tang Y, Tetreault J, Chow CK, et al. Generation and characterization of ixekizumab, a humanized monoclonal antibody that neutralizes interleukin-17A. J Inflamm Res. (2016) 9:39–50. doi: 10.2147/JIR.S100940
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |