Ozmosi | Amlenetug Drug Profile
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Amlenetug

Alternative Names: Amlenetug, lu-af82422, lu af82422, LUAF-82422, LUAF 82422, LUAF82422
Clinical Status: Active
Latest Update: 2025-11-11
Latest Update Note: News Article

Product Description

Lundbeck is developing LU-AF82422 as a treatment for multiple system atrophy. (Sourced from: https://clinicaltrials.gov/ct2/show/NCT05104476)

Mechanisms of Action: aSYN Binder

Novel Mechanism: Yes

Modality: Antibody

Route of Administration: Intravenous

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Lundbeck
Company Location: DENMARK G7 00000
Company CEO:
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Amlenetug

Countries in Clinic: Australia, Canada, China, France, Germany, Italy, Japan, Korea, Poland, Spain, United Kingdom, United States

Active Clinical Trial Count: 7

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Multiple System Atrophy|Shy-Drager Syndrome

Phase 2: Pure Autonomic Failure

Phase 1: Healthy Volunteers

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT05104476

AMULET

P2

Active, not recruiting

Pure Autonomic Failure|Multiple System Atrophy

2023-11-16

12%

2025-08-27

Primary Endpoints|Study Completion Date|Treatments

NCT06706622

MASCOT

P3

Recruiting

Multiple System Atrophy|Shy-Drager Syndrome

2028-02-17

38%

2024-12-05

Primary Endpoints|Treatments|Trial Status

CTR20240449

CTR20240449

P1

Completed

Multiple System Atrophy

2024-09-03

2025-04-29

Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status

jRCT2021240061

jRCT2021240061

P3

Recruiting

Multiple System Atrophy

2029-10-25

2024-517169-18-00

20432A

P3

Not yet recruiting

Multiple System Atrophy

2029-10-31

38%

2025-05-02

Treatments

jRCT2021210061

jRCT2021210061

P2

Active, not recruiting

Multiple System Atrophy

2023-08-30

NCT06258720

19728A

P1

Completed

Healthy Volunteers

2024-09-03

50%

2024-11-13

Primary Endpoints