Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 45 |
| INN | Infliximab |
| Status | Approved |
| Drug code(s) | CENTNF, CA2 |
| Brand name | Remicade, Avakine |
| 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) | TNF |
| Indications of clinical studies | Rheumatoid arthritis, Crohn's disease, ulcerative colitis |
| 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 30, 1991 |
| Start of Phase 2 | August 15, 1993 |
| Start of Phase 3 | June 15, 1996 |
| Date BLA/NDA submitted to FDA | December 30, 1997 |
| Year of first approval (global) | 1998 |
| Date of first US approval | August 24, 1998 |
| INN, US product name | Infliximab |
| US or EU approved indications | Rheumatoid Arthritis, Crohn's Disease, Psoriasis, Ulcerative Colitis, Psoriatic Arthritis, Axial Spondyloarthritis (also Behçet Syndrome in Japan) |
| Company | Centocor |
| Licensee/Partner | Smithkline Beecham |
| Comments about company or candidate | None |
| Full address of company | 800-850 Ridgeview Drive HORSHAM PA 19044 UNITED STATES North America United States of America https://www.orpha.net/en/institutions/legal-entity/82182 |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |