Adalimumab Approved Naked monospecific

Antibody Information

Entry ID	58
INN	Adalimumab
Status	Approved
Drug code(s)	D2E7
Brand name	Humira
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	Phage display, CAT library

Therapeutic information

Target(s)	TNF
Indications of clinical studies	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, Australia
Status	Active
Start of clinical phase (IND filing or first Phase 1)	April 21, 1997
Start of Phase 2	May 15, 1998
Start of Phase 3	February 09, 2000
Date BLA/NDA submitted to FDA	March 29, 2002
Year of first approval (global)	2002
Date of first US approval	December 31, 2002
INN, US product name	Adalimumab
US or EU approved indications	Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Crohn's Disease, Psoriatic Arthritis, Psoriasis, Axial Spondyloarthritis, Ulcerative Colitis, Uveitis, Hidradenitis Suppurativa (also approved for Behçet Syndrome in Japan)

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Abbott
Licensee/Partner	Genentech
Comments about company or candidate	None
Full address of company	100 Abbott Park Road Abbott Park, IL 60064 North America United States of America https://www.abbott.com/contact.html