Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 132 |
| INN | Omalizumab |
| Status | Approved |
| Drug code(s) | RHU-MAB-E25 |
| Brand name | Xolair |
| 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) | IgE |
| Indications of clinical studies | Asthma, allergic rhinitis |
| 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) | December 15, 1993 |
| Start of Phase 2 | July 11, 1994 |
| Start of Phase 3 | September 15, 1997 |
| Date BLA/NDA submitted to FDA | June 05, 2000 |
| Year of first approval (global) | 2003 |
| Date of first US approval | June 20, 2003 |
| INN, US product name | Omalizumab |
| US or EU approved indications | Asthma, Chronic idiopathic urticaria (Moderate to severe persistent asthma in patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids; Chronic idiopathic urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment) |
| Company | Genentech |
| Licensee/Partner | Xoma, Serono |
| Comments about company or candidate | None |
| Full address of company | South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |