Drug Profile

Amlenetug - Lundbeck A/S

Alternative Names: Lu-AF82422

Latest Information Update: 18 Mar 2025

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At a glance

Originator Genmab; Lundbeck A/S
Developer Lundbeck A/S
Class Antibodies; Antiparkinsonians; Monoclonal antibodies
Mechanism of Action Alpha-synuclein inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Multiple system atrophy
New Molecular Entity Yes

Highest Development Phases

Phase III Multiple system atrophy
No development reported Parkinson's disease

Most Recent Events

10 Mar 2025 Amlenetug receives Orphan Drug status for Multiple system atrophy in Japan
12 Feb 2025 Amlenetug - Lundbeck A/S receives Fast Track designation for Multiple system atrophy [IV,Infusion] in USA
03 Dec 2024 Phase-III clinical trials in Multiple system atrophy in USA (IV) (NCT06706622)

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