Dazukibart Clinical Naked monospecific

Antibody Information

Entry ID	1101
INN	Dazukibart
Status	Clinical
Drug code(s)	PF-06823859, PF06823859
Brand name	None
mAb sequence source	mAb humanized
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)	IFN beta
Indications of clinical studies	Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)], Lupus, Dermatomyositis
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)	Phase 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	May 27, 2016
Start of Phase 2	January 23, 2018
Start of Phase 3	May 20, 2023
Date BLA/NDA submitted to FDA
Year of first approval (global)	None
Date of first US approval
INN, US product name	None
US or EU approved indications	None

Company information

Company	Pfizer
Licensee/Partner	None
Comments about company or candidate	NCT06698796 Phase 3 in Idiopathic Inflammatory Myopathies ORPHAN -U.S., E.U., PRIME -E.U.; FAST TRACK – U.S (https://cdn.pfizer.com/pfizercom/product-pipeline/Pipeline_Update_29OCT2024.pdf?VersionId=E70MbubUKVzMZ8UF6fmYfS3KDJLP3pmH) NCT05895786 Phase 3 study in Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM) started in May 2023. NCT05879718 Phase 2 in lupus due to start in June 2023. NCT03181893 Phase 2 study started in Jan 2018 still recruiting patients as of last update in Feb 20121.
Full address of company	66 Hudson Boulevard East, New York, NY 10001-2192 USA North America United States of America https://www.pfizer.com/contact

Description/comment

Immunoglobulin G1 [236-alanine,237-alanine,239-alanine,de-C-terminal-lysine], anti- (human interferon β) (human-Mus musculus monoclonal PF-06823859 γ1-chain), disulfide with human-Mus musculus monoclonal PF-06823859 κ-chain, dimer

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None