Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 52 |
| INN | Ustekinumab |
| Status | Approved |
| Drug code(s) | CNTO-1275 |
| Brand name | Stelara |
| 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) | IL-12/23 p40 |
| Indications of clinical studies | Atopic dermatitis, Psoriasis, Crohn's disease, multiple sclerosis, sarcoidosis, psoriatic 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) | March 15, 2002 |
| Start of Phase 2 | June 15, 2003 |
| Start of Phase 3 | December 15, 2005 |
| Date BLA/NDA submitted to FDA | November 29, 2007 |
| Year of first approval (global) | 2009 |
| Date of first US approval | September 25, 2009 |
| INN, US product name | Ustekinumab |
| US or EU approved indications | Psoriatic Arthritis, Psoriasis (adults and adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy), Crohn’s disease |
| Company | Janssen Research & Development |
| Licensee/Partner | None |
| Comments about company or candidate | None |
| 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 |