YAbS







Infliximab Approved Naked monospecific

Antibody Information

Entry ID 45
INN Infliximab
Status Approved
Drug code(s) CENTNF, CA2
Brand name Remicade, Avakine
mAb sequence source mAb chimeric
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) TNF
Indications of clinical studies Rheumatoid arthritis, Crohn's disease, ulcerative colitis
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 30, 1991
Start of Phase 2 August 15, 1993
Start of Phase 3 June 15, 1996
Date BLA/NDA submitted to FDA December 30, 1997
Year of first approval (global) 1998
Date of first US approval August 24, 1998
INN, US product name Infliximab
US or EU approved indications Rheumatoid Arthritis, Crohn's Disease, Psoriasis, Ulcerative Colitis, Psoriatic Arthritis, Axial Spondyloarthritis (also Behçet Syndrome in Japan)

Company information

Company Centocor
Licensee/Partner Smithkline Beecham
Comments about company or candidate None
Full address of company 800-850 Ridgeview Drive HORSHAM PA 19044 UNITED STATES
North America
United States of America
https://www.orpha.net/en/institutions/legal-entity/82182

Description/comment

None

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None