Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2311 |
| INN | Actoxumab, bezlotoxumab |
| Status | Terminated |
| Drug code(s) | MK-3415A |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Mixture of 2 |
| 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 | Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform) |
| Target(s) | C. difficile (enterotoxin A and B) |
| Indications of clinical studies | Clostridium difficile infection |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2005 |
| Start of Phase 2 | |
| Start of Phase 3 | October 15, 2011 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Bristol Myers Squibb |
| Licensee/Partner | Merck |
| Comments about company or candidate | Phase 3 studies of monotherapy or bezlotoxumab+actoxumab demonstrated that the combination did not provide added efficacy over bezlotoxumab alone |
| Full address of company | New York, United States North America United States of America https://www.bms.com/in |
Mixture with MK-6072 (aka MDX-066, actoxumab, IgG1 kappa); bezlotoxumab = MDX-1388. MK-3415A (combination of mAb to toxin B, MDX-1388, and mAb to toxin A, MK-6072/MDX066/GS-CDA1)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |