Omalizumab Approved Naked monospecific

Antibody Information

Entry ID	132
INN	Omalizumab
Status	Approved
Drug code(s)	RHU-MAB-E25
Brand name	Xolair
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	IgE
Indications of clinical studies	Asthma, allergic rhinitis
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, Japan, Australia
Status	Active
Start of clinical phase (IND filing or first Phase 1)	December 15, 1993
Start of Phase 2	July 11, 1994
Start of Phase 3	September 15, 1997
Date BLA/NDA submitted to FDA	June 05, 2000
Year of first approval (global)	2003
Date of first US approval	June 20, 2003
INN, US product name	Omalizumab
US or EU approved indications	Asthma, Chronic idiopathic urticaria (Moderate to severe persistent asthma in patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids; Chronic idiopathic urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment)

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Genentech
Licensee/Partner	Xoma, Serono
Comments about company or candidate	None
Full address of company	South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us