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Aducanumab

Alternative Names: aducanumab, bart, biib037, Aduhelm, aducanumab-avwa
Latest Update: 2024-07-11
Latest Update Note: News Article

Product Description

Aducanumab (Aduhelm™) has received accelerated approval as a treatment for Alzheimer’s disease from the U.S. Food and Drug Administration (FDA). This is the first FDA-approved therapy to address the underlying biology of Alzheimer’s disease.  It is the first therapy to demonstrate that removing beta-amyloid, one of the hallmarks of Alzheimer’s disease, from the brain is reasonably likely to reduce cognitive and functional decline in people living with early Alzheimer’s. (Sourced from: https://www.alz.org/alzheimers-dementia/treatments/aducanumab)

Mechanisms of Action: AB Antagonist

Novel Mechanism: No

Modality: Antibody

Route of Administration: Intramuscular,Intravenous,Oral,Topical

FDA Designation: Accelerated Approval - Alzheimer Disease *

Approval Status: Approved

Approved Countries: Brazil | Dominican Republic | Italy | United Arab Emirates | United States | Vietnam

Approved Indications: Alzheimer Disease

Known Adverse Events: Headache | Siderosis | Edema

Company: Neurimmune
Company Location:
Company CEO:
Additonal Commercial Interests: Biogen

Clinical Description

Map of Global Clinical Trials for Aducanumab

Countries in Clinic: Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States, Unknown Location

Active Clinical Trial Count: 9

Highest Development Phases

Phase 3: Alzheimer Disease

Phase 1: Cognitive Dysfunction|Healthy Volunteers

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

NCT05469009

P1

Recruiting

Cognitive Dysfunction|Alzheimer Disease

2029-07-01

jRCT2021220027

P3

Recruiting

Alzheimer Disease

2027-05-31

ENVISION

P3

Active, not recruiting

Alzheimer Disease

2025-12-27

2019-004368-22

P3

Active, not recruiting

Alzheimer Disease

2025-02-26

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