Basiliximab Approved Naked monospecific

Antibody Information

Entry ID	47
INN	Basiliximab
Status	Approved
Drug code(s)	CHI-621
Brand name	Simulect
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)	CD25
Indications of clinical studies	Transplant rejection
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, 1991
Start of Phase 2
Start of Phase 3	June 13, 1995
Date BLA/NDA submitted to FDA	November 12, 1997
Year of first approval (global)	1998
Date of first US approval	May 12, 1998
INN, US product name	Basiliximab
US or EU approved indications	Kidney transplant rejection

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Novartis Pharmaceuticals
Licensee/Partner	Hoffman-La Roche
Comments about company or candidate	None
Full address of company	Basel, Switzerland Europe Switzerland https://www.novartis.com/contacts