Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 51 |
| INN | Guselkumab |
| Status | Approved |
| Drug code(s) | CNTO 1959 |
| Brand name | TREMFYA |
| 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 | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Phage display (HuCAL)-based antibody |
| Target(s) | IL-23p19 |
| Indications of clinical studies | Lupus Nephritis, Palmoplantar Pustulosis, Psoriasis, 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) | June 15, 2009 |
| Start of Phase 2 | November 15, 2011 |
| Start of Phase 3 | October 15, 2014 |
| Date BLA/NDA submitted to FDA | November 16, 2016 |
| Year of first approval (global) | 2017 |
| Date of first US approval | July 13, 2017 |
| INN, US product name | Guselkumab |
| US or EU approved indications | Psoriasis (treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy) |
| Company | Janssen Research & Development |
| Licensee/Partner | Morphosys |
| Comments about company or candidate | Approved in US on July 13, 2017; approved in EU Nov 23, 2017 NCT04033445 Phase 2/3 study in ulcerative colitis not yet recruiting as of July 2019. Total of 4 Phase 3 studies, including NCT02203032, started, 1 other Phase 3 studies listed as not yet recruiting, as of March 3 2015. Phase 2 in Palmoplantaris Pustulosis (NCT01845987) completed as of Nov 2014 |
| Full address of company | 1125 Trenton-Harbourton Road Titusville, NJ 08560 North America United States of America https://www.janssen.com/us/contact-us |
IgG1 lambda2
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |