Guselkumab Approved Naked monospecific

Antibody Information

Entry ID	51
INN	Guselkumab
Status	Approved
Drug code(s)	CNTO 1959
Brand name	TREMFYA
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	lambda
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Phage display (HuCAL)-based antibody

Therapeutic information

Target(s)	IL-23p19
Indications of clinical studies	Lupus Nephritis, Palmoplantar Pustulosis, Psoriasis, Rheumatoid arthritis
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, China, Australia
Status	Active
Start of clinical phase (IND filing or first Phase 1)	June 15, 2009
Start of Phase 2	November 15, 2011
Start of Phase 3	October 15, 2014
Date BLA/NDA submitted to FDA	November 16, 2016
Year of first approval (global)	2017
Date of first US approval	July 13, 2017
INN, US product name	Guselkumab
US or EU approved indications	Psoriasis (treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy)

Company information

Company	Janssen Research & Development
Licensee/Partner	Morphosys
Comments about company or candidate	Approved in US on July 13, 2017; approved in EU Nov 23, 2017 NCT04033445 Phase 2/3 study in ulcerative colitis not yet recruiting as of July 2019. Total of 4 Phase 3 studies, including NCT02203032, started, 1 other Phase 3 studies listed as not yet recruiting, as of March 3 2015. Phase 2 in Palmoplantaris Pustulosis (NCT01845987) completed as of Nov 2014
Full address of company	1125 Trenton-Harbourton Road Titusville, NJ 08560 North America United States of America https://www.janssen.com/us/contact-us

Description/comment

IgG1 lambda2

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None