Drug

Aducanumab

In clinical development

ClassAmyloid-beta A4 protein binding agentEmerging researchLate-stage development

Also known as Aduhelm.

RxNorm2557217 ChEMBLCHEMBL3039540 ATCN06DX03UNII105J35OE21

Research papers

Active clinical trials

Amyloid-beta precursor protein

Primary target

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-01-22Results expected Q3 2029 · ClinicalTrials.gov

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

Clinical trial2024-11-29Results posted · ClinicalTrials.gov

Recent advances in Alzheimer's disease: Mechanisms, clinical trials and new drug development strategies.

Research2024-08-23Signal transduction and targeted therapy

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

Clinical trial2024-08-12Terminated · ClinicalTrials.gov

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

Clinical trial2024-07-22Terminated · ClinicalTrials.gov

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

Clinical trial2022-07-27Completed · ClinicalTrials.gov

Two Randomized Phase 3 Studies of Aducanumab in Early Alzheimer's Disease.

Research2022-01-01The journal of prevention of Alzheimer's disease

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

Clinical trial2021-10-01Completed · ClinicalTrials.gov

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

Clinical trial2019-08-08Terminated · ClinicalTrials.gov

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

Clinical trial2019-08-05Terminated · ClinicalTrials.gov

A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease

Clinical trial2019-07-31Terminated · ClinicalTrials.gov

A Phase 2, Multicenter, Randomized, Parallel-Group, Double-Blind, Controlled Study of Aducanumab (BIIB037) in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Subjects With Asymptomatic Amyloid-Related Imaging Abnormalities

Clinical trial2019-07-30Terminated · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Aducanumab

Aliases & brands

Aduhelm

RxNorm CUI

2557217

ChEMBL ID

CHEMBL3039540

ATC codes

N06DX03

UNII

105J35OE21

Primary mechanism

Amyloid-beta A4 protein binding agent

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Amyloid-beta precursor protein

APP · P05067

BINDING AGENTAmyloid-beta A4 protein binding agent

Clinical trials

12 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2023

Active studies

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 12

Early Phase 11Phase 15Phase 21Phase 35

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

TerminatedPH IIIKey trialBiogenn=1,0272024

TerminatedPH IIIKey trialBiogenn=1,6962024

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

CompletedPH IIIEli Lilly and Companyn=1482023

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

TerminatedPH IIIKey trialBiogenn=1,6532019

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

TerminatedPH IIIKey trialBiogenn=1,6432019

Recent completions

Trials that read out recently, adding to the completed evidence base.

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

CompletedPH IIIEli Lilly and Companyn=1482023

CompletedPH IBiogenn=1232022

CompletedPH IBiogenn=302021

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Aducanumab (BIIB037) in Japanese Subjects With Mild to Moderate Alzheimer's Disease

CompletedPH IBiogenn=212016

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

CompletedPH IBiogenn=282016

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20222024

Most influential

Two Randomized Phase 3 Studies of Aducanumab in Early Alzheimer's Disease.

The journal of prevention of Alzheimer's disease · 2022 · 1,003 cites

Recent advances in Alzheimer's disease: Mechanisms, clinical trials and new drug development strategies.

Signal transduction and targeted therapy · 2024 · 640 cites

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Alzheimer's Disease2

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials