Mibavademab Clinical Naked monospecific

Antibody Information

Entry ID	1180
INN	Mibavademab
Status	Clinical
Drug code(s)	REGN4461
Brand name	None
mAb sequence source	mAb human
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG4
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	LEPR
Indications of clinical studies	Obesity, Familial Partial Lipodystrophy, Generalized Lipodystrophy
Primary therapeutic area	Metabolic 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)	April 24, 2018
Start of Phase 2	January 07, 2020
Start of Phase 3	December 16, 2024
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	Regeneron Pharmaceuticals
Licensee/Partner	None
Comments about company or candidate	NCT06548100 Phase 3 in Generalized Lipodystrophy started in Dec 2024. NCT06373146 Phase 2 in obesity due to start in May 2024 sponsored by Lilly Listed as Phase 2 asset in Regeneron pipeline accessed in Mar 2023. NCT05088460 Phase 2 started in Feb 2022 NCT04159415 Phase 2 study in Generalized Lipodystrophy started recruiting in Jan 2020 active not recruiting as of last update in Jan 2023. Listed in Regeneron pipeline update June 2019. NCT03530514 Phase 1 study in healthy volunteers started in April 2018 completed in Jan 2020.
Full address of company	Tarrytown, New York, United States North America United States of America https://www.regeneron.com/

Description/comment

Agonist antibody to leptin receptor ("LEPR") https://www.sec.gov/Archives/edgar/data/872589/000180422023000016/regn-20230331.htm

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None