Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 127 |
| INN | Ocrelizumab |
| Status | Approved |
| Drug code(s) | RG1594, PRO-70769, 2H7 |
| Brand name | Ocrevus |
| 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) | CD20 |
| Indications of clinical studies | Rheumatoid Arthritis, Multiple Sclerosis, Systemic Lupus Erythematosus, Lupus Nephritis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Australia, UK, Switzerland |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2003 |
| Start of Phase 2 | |
| Start of Phase 3 | December 15, 2006 |
| Date BLA/NDA submitted to FDA | April 28, 2016 |
| Year of first approval (global) | 2017 |
| Date of first US approval | March 28, 2017 |
| INN, US product name | Ocrelizumab |
| US or EU approved indications | Multiple sclerosis (relapsing and primary progressive forms of multiple sclerosis) |
| Company | Genentech |
| Licensee/Partner | None |
| Comments about company or candidate | Approved March 28, 2017 in US; approved Sep 27, 2017 in EU; approved Sep 28 2017 in Switzerland Priority review; PDUFA date Dec 28, 2016. Breakthrough therapy designation for primary progressive MS. As of August 2013, focus is on MS studies |
| Full address of company | South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us |
anti-CD20 Fv portion used in mosunetuzumab (?)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |