Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 53 |
| INN | Golimumab |
| Status | Approved |
| Drug code(s) | CNTO-148 |
| Brand name | SIMPONI |
| 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 | Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform Ultimab) |
| Target(s) | TNF |
| Indications of clinical studies | Rheumatoid arthritis, asthma, ulcerative colitis, ankylosing spondylitis, Sarcoidosis |
| 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) | July 02, 2002 |
| Start of Phase 2 | July 02, 2003 |
| Start of Phase 3 | November 15, 2005 |
| Date BLA/NDA submitted to FDA | June 24, 2008 |
| Year of first approval (global) | 2009 |
| Date of first US approval | April 24, 2009 |
| INN, US product name | Golimumab |
| US or EU approved indications | Axial Spondyloarthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Juvenile Rheumatoid Arthritis |
| Company | Janssen Research & Development |
| Licensee/Partner | None |
| Comments about company or candidate | US orphan |
| Full address of company | 1125 Trenton-Harbourton Road Titusville, NJ 08560 North America United States of America https://www.janssen.com/us/contact-us |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |