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

Pharmacology
Reduce drug development failure rates
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Contraindications & Blackbox Warnings
Contraindications
Avoid life-threatening adverse drug events
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Avoid life-threatening adverse drug events & improve clinical decision support.
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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
Adverseeffects
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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

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
  1. 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]
  2. 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]
  3. 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]
  4. 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]
  5. BioPharma Dive: Lilly lays out 2-year plan to gain approval for Alzheimer's drug [Link]
  6. BioPharma Dive: Detailed Lilly data give mixed picture of Alzheimer's drug's benefit [Link]
  7. NCT03367403: A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ) [Link]
Wikipedia
Donanemab

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
3Active Not RecruitingTreatmentAlzheimer's Disease (AD)1
3RecruitingTreatmentAlzheimer's Disease (AD)1
3RecruitingTreatmentAlzheimer's Disease (AD) / Mild Cognitive Impairment (MCI)1
2Active Not RecruitingTreatmentAlzheimer's Disease (AD)1
2RecruitingTreatmentAlzheimer's Disease (AD) / Brain Diseases / Central Nervous System Diseases / Cognitive Impairment (CI) / Dementia1
1CompletedBasic ScienceAlzheimer's Disease (AD)2

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