Product

Aducanumab

Aliases

Aducanumab-avwa, Aduhelm, BIIB037

Name

Aduhelm

INN Name

Aducanumab

FDA Approved

Yes

6 clinical trials

1 organization

6 indications

1 document

Indication

Alzheimer's Disease

Indication

Mild Cognitive Impairment

Indication

Alzheimer's disease

Indication

Healthy Control Participants

Indication

Healthy Volunteer

Indication

Alzheimer Disease

Clinical trial

A Phase 3b/4 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants With Alzheimer's Disease

Status: Active (not recruiting), Estimated PCD: 2025-12-27

Clinical trial

Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

Status: Active (not recruiting), Estimated PCD: 2024-01-19

Clinical trial

A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic Alzheimer's Disease

Status: Completed, Estimated PCD: 2022-09-09

Clinical trial

A Randomized, Open-Label, Parallel-Arm Study to Assess the Pharmacokinetic Comparability of 2 Fixed Subcutaneous Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous Dose in Healthy Volunteers

Status: Completed, Estimated PCD: 2022-07-27

Clinical trial

A Randomized, Open-Label, Parallel-Arm Study to Assess the Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab (BIIB037) Compared to a Single, Weight-Based Intravenous Dose in Healthy Volunteers

Status: Completed, Estimated PCD: 2021-10-01

Clinical trial

Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for the Treatment of Patients With With Mild Cognitive Impairment (MCI) or Mild Alzheimer's Disease (AD) Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy

Status: Recruiting, Estimated PCD: 2029-07-01

Document

DailyMed Label: Aduhelm

Organization