Amlenetug Clinical Naked monospecific

Antibody Information

Entry ID	945
INN	Amlenetug
Status	Clinical
Drug code(s)	Lu AF82422
Brand name	None
mAb sequence source	mAb human
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)	Alpha synuclein
Indications of clinical studies	Multiple System Atrophy, Parkinson's disease
Primary therapeutic area	Neurological 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)	July 25, 2018
Start of Phase 2	November 15, 2021
Start of Phase 3	November 15, 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	H. Lundbeck A/S
Licensee/Partner	Genmab
Comments about company or candidate	Feb 2025: FDA has granted Fast Track Designation to Lundbeck’s investigational drug, amlenetug, a potential new treatment option targeting Multiple System Atrophy. Nov 27, 2024: H. Lundbeck A/S announced the advancement of the clinical development of amlenetug (Lu AF82422) for the treatment of MSA with the initiation of MASCOT, a randomized, double-blind, phase III trial. NCT06706622 Phase 3 in Multiple System Atrophy due to start in Dec 2024. Listed as Phase 2 asset in company pipeline accessed Mar 2023. NCT05104476 Phase 2 study in Multiple System Atrophy started in Nov 2021 active not recruiting as of last update in Dec 2022. NCT03611569 Phase 1 study in Parkinson's disease started in July 2018 completed in July 2021. Lu AF82422 was invented by Lundbeck in collaboration with Genmab.
Full address of company	Ottiliavej 9, 2500 Valby, Denmark Europe Denmark https://www.lundbeck.com/global

Description/comment

Lu AF82422 is a human IgG1 mAb that recognizes all major species of alpha-synuclein. Extracellular alpha-synuclein is believed to play a major role in disease pathology and progression in Parkinson’s disease.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None