Aduhelm

(Aducanumab)

Phase 2Monoclonal antibody

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

Aduhelm is one of 92 monoclonal antibody programs targeting Alzheimer disease. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Alzheimer DiseaseUnknown

Cognitive ImpairmentTerminated

Alzheimer DiseasePreclinical

Unknown

Cognitive ImpairmentPhase 2

Terminated

Competition

Competitive Landscape

100 competitors in Alzheimer Disease

#DrugCompanyPhaseTrials

Thalomid

Soriatane

Minipress

Marinol

Lexapro

Calciferol

Azilect

Kisunla

4 9

Raldesy

Abilify

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

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

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

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

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

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

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 2[1]
Company: Biogen

Key Publications[4]

Outcomes after discharge from acute hospital to residential aged care among long-stay inpatients: a retrospective cohort study using a health service long-stay dashboard.

Aust Health RevSep 3, 2026DOI: 10.1071/AH26115

Extended dispensing intervals for pancreatic enzyme extract without access destabilisation: a national retrospective study evaluating supply resilience during policy changes and medicine shortages in Australia.

Aust Health RevSep 3, 2026DOI: 10.1071/AH26080

Equine Fungal Keratitis due to Cladorrhinum bulbillosum.

Vet OphthalmolSep 1, 2026DOI: 10.1111/vop.70249

Therapies for Cardiovascular-Kidney-Liver-Metabolic Syndrome: Reappraisal of Fibrates.

Diabetes Obes MetabAug 17, 2026DOI: 10.1111/dom.71230

Trajectories of refraction and strabismus from 2.5 to 12 years in a national cohort of extremely preterm children- the Extremely Preterm Infants in Sweden Study (EXPRESS).

Acta OphthalmolAug 17, 2026DOI: 10.1111/aos.70222

Epidural 0.125% ropivacaine is safe but insufficient for induced tibiotarsal joint pain.

Equine Vet JAug 17, 2026DOI: 10.1002/evj.70298

From Snapshot to Trajectory: The RV-3 Check for Pulmonary Arterial Hypertension Follow-up.

EchocardiographyAug 1, 2026DOI: 10.1111/echo.70600

Intermuscular Adipose Tissue as a Multimodality Quantitative Imaging Biomarker: Evidence Across Metabolic, Cardiovascular and Oncologic Diseases.

J Cachexia Sarcopenia MuscleAug 1, 2026DOI: 10.1002/jcsm.70366

Cold Ischemia Time Is an Important Risk Factor for Prolonged Length of Stay Post-Lung Transplantation.

Clin TransplantAug 1, 2026DOI: 10.1111/ctr.70651

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