Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 108 |
| INN | Tocilizumab |
| Status | Approved |
| Drug code(s) | MRA, RHPM-1, RG1569 |
| Brand name | RoActemra, Actemra |
| mAb sequence source | mAb humanized |
| 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 | None |
| Target(s) | IL-6R |
| Indications of clinical studies | COVID-19, Giant lymph node hyperplasia (Castleman's Disease), rheumatoid arthritis, multiple myeloma |
| 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, 1998 |
| Start of Phase 2 | February 15, 2000 |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | November 19, 2007 |
| Year of first approval (global) | 2005 |
| Date of first US approval | January 08, 2010 |
| INN, US product name | Tocilizumab |
| US or EU approved indications | Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis. Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients two years of age and older; treatment for patients age 2 and older with active systemic juvenile idiopathic arthritis. |
| Company | Hoffmann-La Roche |
| Licensee/Partner | None |
| Comments about company or candidate | Emergency use authorization granted by FDA on June 24, 2021 for COVID-19. First approved in Japan on April 11, 2005 |
| Full address of company | Basel, Switzerland Europe Switzerland https://www.roche.com/about |
INN was fomerly atlizumab
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |