Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 131 |
| INN | Ranibizumab |
| Status | Approved |
| Drug code(s) | rhuFAB V2 |
| Brand name | Lucentis |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Fragment |
| Format details | Fab |
| Isotype (Fc) | None |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Phage display |
| Target(s) | VEGF |
| Indications of clinical studies | Neovascular age-related macular degeneration |
| Primary therapeutic area | Ophthalmic disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 15, 2000 |
| Start of Phase 2 | September 15, 2002 |
| Start of Phase 3 | March 19, 2003 |
| Date BLA/NDA submitted to FDA | December 30, 2005 |
| Year of first approval (global) | 2006 |
| Date of first US approval | June 30, 2006 |
| INN, US product name | Ranibizumab |
| US or EU approved indications | Wet Age-Related Macular Degeneration, Diabetic Macular Edema, Macular Edema from Retinal Vein Occlusion, Diabetic Retinopathy, Choroidal Neovascularization |
| Company | Genentech |
| Licensee/Partner | None |
| Comments about company or candidate | As per FDA review documents, Genentech submitted an IND on Oct 9, 1999. BLA was received by FDA Dec. 30, 2005, and approved June 30, 2006. BLA included data from a total of 6 studies (2 Phase 1 studies, 2 Phase 1/2 studies and 2 Phase 3 studies). Studies were conducted in the US with the exception of one Phase 3 study co-sponsored by Novartis. |
| Full address of company | South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us |
Ranibizumab was created using mouse mAb A4.6.1 as a starting point and phage display was used in candidate optimization; Fab created from the same parent mouse antibody as bevacizumab. Immunoglobulin G1, anti-(human vascular endothelial growth factor) Fab fragment (human-mouse monoclonal rhuFAB V2 γ1-chain), disulfide with human-mouse monoclonal rhuFAB V2 κ-chain
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |