TAbS







Reslizumab Approved Naked monospecific

Antibody Information

Entry ID 46
INN Reslizumab
Status Approved
Drug code(s) CEP-38072, CDP-835, SCH-55700
Brand name Cinquil
mAb sequence source mAb humanized
General Molecular Category Naked monospecific
Format, general category Full length Ab
Format details None
Isotype (Fc) IgG4
Light chain isotype kappa
Linker None
Ave. DAR None
Conjugated/fused moiety None
Discovery method/technology None

Therapeutic information

Target(s) IL-5
Indications of clinical studies Eosinophilic Asthma, Eosinophilic Esophagitis
Primary therapeutic area Immune-mediated / inflammatory disorders

Development stage information


Most advanced stage of development (global) Approved EU, US, Australia
Status Active
Start of clinical phase (IND filing or first Phase 1) July 02, 1997
Start of Phase 2
Start of Phase 3 February 15, 2008
Date BLA/NDA submitted to FDA March 30, 2015
Year of first approval (global) 2016
Date of first US approval March 23, 2016
INN, US product name Reslizumab
US or EU approved indications Astham (Add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype)

Company information

Company UCB
Licensee/Partner Teva, Schering-Plough
Comments about company or candidate Positive Phase III Results for Reslizumab Reducing Asthma Exacerbations released in Sep 2014 Partner Teva acquired Cephalon in 2011; Cephalon acquired Ception in 2009.
Full address of company Allée de la Recherche, 60 1070 Brussels Belgium
Europe
Belgium
https://www.ucb.com/contact

Description/comment

Wild-type hinge

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None