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

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, 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	Asthma (Add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype)

Description/comment

Wild-type hinge

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

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