Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 73 |
| INN | Rituximab |
| Status | Approved |
| Drug code(s) | IDEC-C2B8 |
| Brand name | Rituxan |
| mAb sequence source | mAb chimeric |
| 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) | CD20 |
| Indications of clinical studies | Non-Hodgkin's B-cell lymphoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 1992 |
| Start of Phase 2 | November 15, 1993 |
| Start of Phase 3 | April 15, 1995 |
| Date BLA/NDA submitted to FDA | February 28, 1997 |
| Year of first approval (global) | 1997 |
| Date of first US approval | November 26, 1997 |
| INN, US product name | Rituximab |
| US or EU approved indications | Non-Hodgkin’s Lymphoma and diffuse large B-cell lymphoma, Chronic Lymphocytic Leukemia, Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies, Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids; moderate to severe pemphigus vulgaris; granulomatosis with polyangiitis and microscopic polyangiitis in children 2 years of age and older in combination with glucocorticoids . As of March 2019, MabThera is approved to treat four autoimmune diseases in the US and Europe. |
| Company | Biogen Idec |
| Licensee/Partner | Schering, Genentech |
| Comments about company or candidate | None |
| Full address of company | 225 Binney Street, Cambridge, MA 02142, USA North America United States of America https://www.biogen.com/company/contact-us.html |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |