YAbS







Ranibizumab Approved Naked monospecific

Antibody Information

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

Therapeutic information

Target(s) VEGF
Indications of clinical studies Neovascular age-related macular degeneration
Primary therapeutic area Ophthalmic disorders

Development stage information

Phase lengths*
*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).
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 information

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

Description/comment

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

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None