Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 58 |
| INN | Adalimumab |
| Status | Approved |
| Drug code(s) | D2E7 |
| Brand name | Humira |
| 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 | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Phage display, CAT library |
| Target(s) | TNF |
| Indications of clinical studies | Rheumatoid arthritis |
| 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) | April 21, 1997 |
| Start of Phase 2 | May 15, 1998 |
| Start of Phase 3 | February 09, 2000 |
| Date BLA/NDA submitted to FDA | March 29, 2002 |
| Year of first approval (global) | 2002 |
| Date of first US approval | December 31, 2002 |
| INN, US product name | Adalimumab |
| US or EU approved indications | Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Crohn's Disease, Psoriatic Arthritis, Psoriasis, Axial Spondyloarthritis, Ulcerative Colitis, Uveitis, Hidradenitis Suppurativa (also approved for Behçet Syndrome in Japan) |
| Company | Abbott |
| Licensee/Partner | Genentech |
| Comments about company or candidate | None |
| Full address of company | 100 Abbott Park Road Abbott Park, IL 60064 North America United States of America https://www.abbott.com/contact.html |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |