Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 100 |
| INN | Bezlotoxumab |
| Status | Approved |
| Drug code(s) | MDX-1388 |
| Brand name | Zinplava |
| mAb sequence source | mAb human |
| 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 | Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform Ultimab) |
| Target(s) | C. difficile (enterotoxin B) |
| Indications of clinical studies | Clostridium Difficile Infection |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Approved EU, US, Japan |
| Status | Active |
| 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 | November 23, 2015 |
| Year of first approval (global) | 2016 |
| Date of first US approval | October 21, 2016 |
| INN, US product name | Bezlotoxumab |
| US or EU approved indications | Reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence. |
| Company | Bristol-Myers Squibb |
| Licensee/Partner | Merck |
| Comments about company or candidate | PDUFA date Oct 23 2016; priority review by FDA; Phase 3 studies of monotherapy or bezlotoxumab+actoxumab demonstrated that the combination did not provide added efficacy over bezlotoxumab alone |
| Full address of company | Route 206 & Province Line Road Princeton, New Jersey 08543 North America United States of America https://www.bms.com/about-us/contact-us.html |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |