Drug intelligence / Profile preview

amlenetug

Development stage
Phase 3
Lead developer
Lundbeck
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Amlenetug is a human IgG1 monoclonal antibody developed for the treatment of multiple system atrophy (MSA), a rare and progressive neurodegenerative disorder. It is designed to bind to all major forms of extracellular alpha-synuclein, thereby preventing its uptake and inhibiting the seeding and aggregation of this pathogenic protein. The active Fc region of amlenetug may also enhance immune-mediated clearance of alpha-synuclein via microglial uptake. Developed by Lundbeck in collaboration with Genmab, amlenetug has received Orphan Drug Designation in the US, EU, and Japan as well as Fast Track Designation from the US FDA. Clinical development includes phase II (AMULET) and ongoing phase III (MASCOT) trials for MSA[1][2][3][4][6][7][8].

Other names
Lu AF82422
02

Targets

SNCA (Alpha-synuclein)

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