Aduhelm

(Aducanumab)

Phase 3Monoclonal antibody

Aduhelm is a monoclonal antibody that works as Amyloid Beta Inhibitor.[2] It is being investigated across 3 indications, with its most advanced program in Phase 3.[1]

Aduhelm is one of 97 monoclonal antibody programs targeting Cognitive impairment. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Cognitive ImpairmentActive, not recruiting

Alzheimer DiseaseUnknown

Alzheimer's DiseaseActive, not recruiting

Cognitive ImpairmentPhase 2

Active, not recruiting

Alzheimer DiseasePreclinical

Unknown

Alzheimer's DiseasePhase 3

Active, not recruiting

Competition

Competitive Landscape

279 competitors in Cognitive Impairment

#DrugCompanyPhaseTrials

Actos

Takeda

Phase 3

3 2

Farxiga

AstraZeneca

Phase 3

1 3

Provigil

NNuvo Research GmbH

Phase 3

1 4

Xarelto

WWim Janssens

Phase 3

1 5

Aquasol E

NNational Eye Institute (NEI)

Phase 3

1 6

Viagra

VViatris Specialty LLC

Phase 3

1 7

Donepezil Hydrochloride

Eisai

Phase 3

3 8

Statins

Sanofi

Phase 3

1 9

Galantamine Hydrobromide

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Phase 3

4 10

Karxt

Bristol-Myers Squibb

Phase 3

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2029

Phase 1Active, not recruiting

Cognitive Impairment

NCT05469009

Clinical

Trials by Indication[1]

Alzheimer's Disease4 trials

A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT05108922·148 enrolled

Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease

Terminated· Biogen logo

Biogen·Phase 1·NCT01677572·197 enrolled

Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease

Completed· Biogen logo

Biogen·Phase 1·NCT02434718·21 enrolled

Show 1 more trial

AWAKEN: Aducanumab Open-Label Extension in AD

Terminated· Biogen logo

Biogen·Phase 3·NCT04241068·1,200 enrolled

Early Alzheimer's Disease3 trials

221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

Terminated· Biogen logo

Biogen·Phase 3·NCT02484547·1,643 enrolled

221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

Terminated· Biogen logo

Biogen·Phase 3·NCT02477800·1,653 enrolled

A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease

Terminated· Biogen logo

Biogen·Phase 3·NCT05310071·1,027 enrolled

Cognitive impairment2 trials

A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities

Terminated· Biogen logo

Biogen·Phase 2·NCT03639987·52 enrolled

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

Active, not recruiting·AAli Rezai·Phase 1·NCT05469009·15 enrolled

Intravenous1 trial

A Study to Assess the Pharmacokinetic (PK) Comparability of 2 Fixed Subcutaneous (SC) Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous (IV) Dose in Healthy Volunteers

Completed· Biogen logo

Biogen·Phase 1·NCT05216887·123 enrolled

ART1 trial

Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants

Completed· Biogen logo

Biogen·Phase 1·NCT02782975·28 enrolled

1 more indication

ESS1 trial

A Study to Assess Absolute Bioavailability of Aducanumab in Healthy Volunteers

Completed· Biogen logo

Biogen·Phase 1·NCT04924140·30 enrolled

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Aducanumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Aducanumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Aducanumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
PubMed — 10 publications indexed for Aducanumab. U.S. National Library of Medicine.
[5]
SEC EDGAR — Biogen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Amyloid Beta Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Biogen

Key Publications[4]

Exploring the potential role of miR-124 in angiogenesis in colorectal cancer.

J Cancer Res Clin OncolJul 10, 2026DOI: 10.1007/s00432-026-06550-5

A Replicable NeuroMark Template for Whole-Brain SPECT Reveals Data-Driven Perfusion Networks and Their Alterations in Schizophrenia.

NeuroinformaticsJul 10, 2026DOI: 10.1007/s12021-026-09798-x

Reversible and irreversible BTK inhibition promotes stem-like functional multipotency, persistence, and antitumor efficacy of CD19-directed CAR T cells in mantle cell lymphoma.

LeukemiaJul 9, 2026DOI: 10.1038/s41375-026-03032-y

A scoping review on stigma and work life in substance users.

WorkJul 9, 2026DOI: 10.1177/10519815261464994

Training needs of clinical physical therapists in provinces of Khyber Pakhtunkhwa and Sindh, Pakistan: A cross-sectional survey.

WorkJul 9, 2026DOI: 10.1177/10519815261459069

Assessment of the Immunological Effects of DNA Vaccines Carrying Antigen Genes for OVA, OMP and OVA-OMP Against Aeromonas hydrophila and Aeromonas caviae Infections in Sinocyclocheilus grahami and Oreochromis niloticus.

J Fish DisJul 9, 2026DOI: 10.1111/jfd.70241

Platelet-Derived Growth Factor Receptor α-Targeted Cell Membrane-Camouflaged Nanotherapy Disrupts Fibrosis-Inflammation Coupling in Intervertebral Disc Degeneration.

ACS NanoJul 9, 2026DOI: 10.1021/acsnano.6c02887

Acetabular superior wall fractures: a distinct acetabular fracture entity.

Arch Orthop Trauma SurgJul 9, 2026DOI: 10.1007/s00402-026-06407-z

What contributes to our perception of the Shepard Tabletop Illusion?

Atten Percept PsychophysJul 9, 2026DOI: 10.3758/s13414-026-03306-8

Treatment of Lenke 5 curves with short versus long posterior fusion.

Spine DeformJul 9, 2026DOI: 10.1007/s43390-026-01499-4