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Aduhelm (ADUCANUMAB)
At a glance
| Generic name | ADUCANUMAB |
|---|---|
| Sponsor | Biogen |
| Drug class | Amyloid Beta-directed Antibody |
| Target | Amyloid beta A4 protein |
| Modality | Monoclonal antibody |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2021 |
Approved indications
- Alzheimer's disease
Common side effects
Key clinical 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 (EARLY_PHASE1)
- A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease (PHASE3)
- A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205 (PHASE3)
- A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4) (PHASE3)
- An Observational Study of Aducanumab-avwa in Participants With Alzheimer's Disease in the US
- 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 (PHASE1)
- A Study to Assess Absolute Bioavailability of Aducanumab in Healthy Volunteers (PHASE1)
- 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 (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Aduhelm CI brief — competitive landscape report
- Aduhelm updates RSS · CI watch RSS
- Biogen portfolio CI