Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 135 |
| INN | None |
| Status | Approved |
| Drug code(s) | Rmab, SII Rmab, 17C7 |
| Brand name | RabiShield |
| 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 | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (Medarex/BMS) |
| Target(s) | Rabies virus (glycoprotein) |
| Indications of clinical studies | Rabies virus infection |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Approved India |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2007 |
| Start of Phase 2 | |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2016 |
| Date of first US approval | |
| INN, US product name | Rmab |
| US or EU approved indications | None |
| Company | Serum Institute of India |
| Licensee/Partner | None |
| Comments about company or candidate | Approved in India for post-exposure Prophylaxis of rabies Partnership between MassBiologics and Serum Institute of India. Phase 1 study reported in Vaccine. 2012 Nov 26;30(50):7315-20. doi: 10.1016/j.vaccine.2012.09.027. |
| Full address of company | 212/2, Hadapsar, Off Soli Poonawalla Road, Pune 411028 India Asia India https://www.seruminstitute.com/contact_us.php |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |