YAbS







Abciximab Approved Naked monospecific

Antibody Information

Entry ID 3
INN Abciximab
Status Approved
Drug code(s) 7E 3
Brand name Reopro
mAb sequence source mAb chimeric
General Molecular Category Naked monospecific
Format, general category Fragment
Format details Fab
Isotype (Fc) None
Light chain isotype kappa
Linker None
Ave. DAR None
Conjugated/fused moiety None
Discovery method/technology None

Therapeutic information

Target(s) GP IIb/IIIa receptor
Indications of clinical studies Prevention of blood clots
Primary therapeutic area Cardiovascular / hemostasis 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
Status Active
Start of clinical phase (IND filing or first Phase 1) July 02, 1987
Start of Phase 2 November 15, 1989
Start of Phase 3 November 26, 1991
Date BLA/NDA submitted to FDA December 16, 1993
Year of first approval (global) 1994
Date of first US approval December 22, 1994
INN, US product name Abciximab
US or EU approved indications Acute Coronary Syndrome, Percutaneous Coronary Interventions for Stable Angina

Company information

Company Centocor
Licensee/Partner Tanabe Seiyaku
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