Golimumab Approved Naked monospecific

Antibody Information

Entry ID	53
INN	Golimumab
Status	Approved
Drug code(s)	CNTO-148
Brand name	SIMPONI
mAb sequence source	mAb human
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	Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform Ultimab)

Therapeutic information

Target(s)	TNF
Indications of clinical studies	Rheumatoid arthritis, asthma, ulcerative colitis, ankylosing spondylitis, Sarcoidosis
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)	July 02, 2002
Start of Phase 2	July 02, 2003
Start of Phase 3	November 15, 2005
Date BLA/NDA submitted to FDA	June 24, 2008
Year of first approval (global)	2009
Date of first US approval	April 24, 2009
INN, US product name	Golimumab
US or EU approved indications	Axial Spondyloarthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Juvenile Rheumatoid Arthritis

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Janssen Research & Development
Licensee/Partner	None
Comments about company or candidate	US orphan
Full address of company	1125 Trenton-Harbourton Road Titusville, NJ 08560 North America United States of America https://www.janssen.com/us/contact-us