Donanemab
Identification
- Generic Name
- Donanemab
- DrugBank Accession Number
- DB16647
- Background
Donanemab (LY3002813) is a humanized IgG1 monoclonal antibody targeted against an epitope at the N-terminal of a specific type of amyloid beta (Aβ) - pyroglutamate Aβ - which is found only in the brain amyloid plaques associated with Alzheimer's Disease (AD).1 It works by inducing microglial-mediated clearance of existing Aβ plaques with the intent of slowing the progressive decline in cognitive function associated with AD.
A phase II study conducted by Eli Lilly and published in March 2021 (TRAILBLAZER-ALZ7), which looked at 257 patients with early symptomatic AD, found that patients receiving donanemab experienced a roughly 30% slower progression in AD as measured by a disease rating scale (iADRS4), although results for secondary endpoints were mixed.3,6
In March 2021, Eli Lilly announced an expanded trial, named TRAILBLAZER-ALZ 2, which will seek to confirm the results of the first trial with an expanded patient population in order to address some of the deficiencies of the original.5
- Type
- Biotech
- Groups
- Investigational
- Biologic Classification
- Protein Based Therapies
Monoclonal antibody (mAb) - Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- Donanemab
- External IDs
- LY 3002813
- LY-3002813
- LY3002813
Pharmacology
- Indication
Not Available
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- Pharmacodynamics
Not Available
- Mechanism of action
Donanemab is presumed to exert its therapeutic effects by clearing amyloid beta (Aβ) plaques in the brain, though a clear link between plaque reductions and clinical outcomes was not observed in initial trials.6 Donanemab is a monoclonal antibody targeted against a specific epitope on a form of post-translationally modified Aβ plaque seen only in the brains of patients with Alzheimer's Disease, namely the N-terminus of pyroglutamate Aβ - after binding, donanemab induces microglial-mediated clearance of these plaques.1
- Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
- Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.
- Toxicity
Not Available
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.Not Available
- Food Interactions
- Not Available
Categories
- ATC Codes
- N06DX05 — Donanemab
- Drug Categories
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- 1ADB65P1KK
- CAS number
- 1931944-80-7
References
- General References
- Lowe SL, Willis BA, Hawdon A, Natanegara F, Chua L, Foster J, Shcherbinin S, Ardayfio P, Sims JR: Donanemab (LY3002813) dose-escalation study in Alzheimer's disease. Alzheimers Dement (N Y). 2021 Feb 14;7(1):e12112. doi: 10.1002/trc2.12112. eCollection 2021. [Article]
- Lynch CA, Walsh C, Blanco A, Moran M, Coen RF, Walsh JB, Lawlor BA: The clinical dementia rating sum of box score in mild dementia. Dement Geriatr Cogn Disord. 2006;21(1):40-3. doi: 10.1159/000089218. Epub 2005 Oct 25. [Article]
- Mintun MA, Lo AC, Duggan Evans C, Wessels AM, Ardayfio PA, Andersen SW, Shcherbinin S, Sparks J, Sims JR, Brys M, Apostolova LG, Salloway SP, Skovronsky DM: Donanemab in Early Alzheimer's Disease. N Engl J Med. 2021 Mar 13. doi: 10.1056/NEJMoa2100708. [Article]
- Wessels AM, Andersen SW, Dowsett SA, Siemers ER: The Integrated Alzheimer's Disease Rating Scale (iADRS) Findings from the EXPEDITION3 Trial. J Prev Alzheimers Dis. 2018;5(2):134-136. doi: 10.14283/jpad.2018.10. [Article]
- BioPharma Dive: Lilly lays out 2-year plan to gain approval for Alzheimer's drug [Link]
- BioPharma Dive: Detailed Lilly data give mixed picture of Alzheimer's drug's benefit [Link]
- NCT03367403: A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ) [Link]
- External Links
- Wikipedia
- Donanemab
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 3 Active Not Recruiting Treatment Alzheimer's Disease (AD) 1 3 Completed Treatment Alzheimer's Disease (AD) / Mild Cognitive Impairment (MCI) 1 3 Recruiting Treatment Alzheimer's Disease (AD) 1 3 Recruiting Treatment Alzheimer's Disease (AD) / Brain Disorders / Central Nervous System Disorder / Dementia / Diseases of the Nervous System / Neurocognitive Disorders / Neurodegenerative Disorders / Psychiatric Disorder NOS 1 3 Recruiting Treatment Alzheimer's Disease (AD) / Brain Disorders / Central Nervous System Disorder / Dementia / Diseases of the Nervous System / Neurocognitive Disorders / Neurodegenerative Disorders / Psychiatric Disorder NOS / Tauopathies 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
- Not Available
- Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
- Not Available
Drug created at March 21, 2021 01:37 / Updated at March 26, 2021 03:55