Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 47 |
| INN | Basiliximab |
| Status | Approved |
| Drug code(s) | CHI-621 |
| Brand name | Simulect |
| 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) | CD25 |
| Indications of clinical studies | Transplant rejection |
| 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) | July 02, 1991 |
| Start of Phase 2 | |
| Start of Phase 3 | June 13, 1995 |
| Date BLA/NDA submitted to FDA | November 12, 1997 |
| Year of first approval (global) | 1998 |
| Date of first US approval | May 12, 1998 |
| INN, US product name | Basiliximab |
| US or EU approved indications | Kidney transplant rejection |
| Company | Novartis Pharmaceuticals |
| Licensee/Partner | Hoffman-La Roche |
| Comments about company or candidate | None |
| Full address of company | Basel, Switzerland Europe Switzerland https://www.novartis.com/contacts |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |