Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 23 |
| INN | Natalizumab |
| Status | Approved |
| Drug code(s) | AN-100226 |
| Brand name | Tysabri |
| 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 | None |
| Target(s) | Integrin alpha-4 |
| Indications of clinical studies | Multiple sclerosis, Crohn's disease, ulcerative colitis |
| 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) | June 15, 1995 |
| Start of Phase 2 | June 15, 1996 |
| Start of Phase 3 | November 20, 2001 |
| Date BLA/NDA submitted to FDA | May 24, 2004 |
| Year of first approval (global) | 2004 |
| Date of first US approval | November 23, 2004 |
| INN, US product name | Natalizumab |
| US or EU approved indications | Multiple sclerosis, Crohn's disease (TYSABRI is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis, and TYSABRI is indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF) |
| Company | Biogen Idec |
| Licensee/Partner | Ajinomoto |
| Comments about company or candidate | None |
| Full address of company | 225 Binney Street, Cambridge, MA 02142, USA North America United States of America https://www.biogen.com/company/contact-us.html |
Wild-type hinge
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |