Donanemab

Generic Name: Donanemab

Brand Names: Kisunla, 记能达

Drug Type: Biotech

CAS Number: 1931944-80-7

Unique Ingredient Identifier: 1ADB65P1KK

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). 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-ALZ), 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 (iADRS), although results for secondary endpoints were mixed.

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.

Indication: 用于治疗阿尔茨海默病。

Clinical Trials

Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation

Phase 4

Not yet recruiting

Conditions: Down Syndrome (DS)
Down Syndrome (Trisomy 21)
Alzheimer Disease
Amyloid Beta Protein

Interventions: Drug: Donanemab
Drug: Placebo

First Posted Date: 2025-04-04

Last Posted Date: 2025-04-04

Lead Sponsor: Michael Rafii, MD, PhD

Target Recruit Count: 60

Registration Number: NCT06911944

A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease

Recruiting

Conditions: Alzheimer Disease

Interventions: Drug: Donanemab
Drug: Usual Care

First Posted Date: 2024-08-22

Last Posted Date: 2025-02-12

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 3060

Registration Number: NCT06566170

Locations: 🇺🇸
Rehabilitation & Neurological Services, Huntsville, Alabama, United States

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Phase 3

Active, not recruiting

Conditions: Alzheimer's Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

Interventions: Drug: Donanemab
Drug: Placebo
Drug: Dexamethasone

First Posted Date: 2023-02-22

Last Posted Date: 2025-05-11

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 1100

Registration Number: NCT05738486

Locations: 🇺🇸
Irvine Clinical Research, Irvine, California, United States
🇺🇸
Neuropsychiatric Research Center of Southwest Florida, Fort Myers, Florida, United States
🇺🇸
Palm Beach Neurology, West Palm Beach, Florida, United States

and more 43 locations

A Study of Donanemab (LY3002813) in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Donanemab

First Posted Date: 2022-10-05

Last Posted Date: 2024-10-04

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 42

Registration Number: NCT05567159

Locations: 🇺🇸
ICON Early Phase Services Lenexa Center, Salt Lake City, Utah, United States

A Study of Donanemab (LY3002813) in Healthy Chinese Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Placebo
Drug: Donanemab

First Posted Date: 2022-09-09

Last Posted Date: 2024-10-04

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 36

Registration Number: NCT05533411

Locations: 🇨🇳
The Third Xiangya Hospital of Central South University, Changsha, Hunan, China
🇨🇳
Peking University First Hospital, Beijing, Beijing, China

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

Phase 3

Recruiting

Conditions: Alzheimer Disease
Dementia
Neurocognitive Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Mental Disorders
Neurodegenerative Diseases

Interventions: Drug: Donanemab
Drug: Placebo

First Posted Date: 2022-08-19

Last Posted Date: 2025-04-20

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 1500

Registration Number: NCT05508789

Locations: 🇦🇷
Clinica Privada Banfield, Banfield, Buenos Aires, Argentina
🇦🇷
IDIM - Instituto de Investigaciones Metabólicas, Ciudad de Buenos Aires, Buenos Aires, Argentina
🇦🇷
INSA Instituto de Neurociencia San Agustin, La Plata, Buenos Aires, Argentina

and more 120 locations

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

Phase 3

Completed

Conditions: Alzheimer Disease
Mild Cognitive Impairment (MCI)

Interventions: Drug: Donanemab
Drug: Aducanumab

First Posted Date: 2021-11-05

Last Posted Date: 2024-11-28

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 148

Registration Number: NCT05108922

Locations: 🇺🇸
Neurology Center of North Orange County, Fullerton, California, United States
🇺🇸
Josephson Wallack Munshower Neurology, PC, Indianapolis, Indiana, United States
🇺🇸
Conquest Research, Winter Park, Florida, United States

and more 27 locations

A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

Phase 3

Recruiting

Conditions: Alzheimer Disease

Interventions: Drug: Placebo
Drug: Donanemab

First Posted Date: 2021-08-30

Last Posted Date: 2025-05-11

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 2996

Registration Number: NCT05026866

Locations: 🇺🇸
Parkway Medical Center, Birmingham, Alabama, United States
🇺🇸
Alabama Psychiatry - Birmingham - Brookwood Medical Center Drive, Homewood, Alabama, United States
🇺🇸
Rehabilitation & Neurological Services, Huntsville, Alabama, United States

and more 222 locations

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

Phase 2

Completed

Conditions: Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Cognitive Impairment

Interventions: Other: No Intervention
Drug: donanemab

First Posted Date: 2020-11-23

Last Posted Date: 2024-04-23

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 94

Registration Number: NCT04640077

Locations: 🇺🇸
Bradenton Research Center, Inc., Bradenton, Florida, United States
🇺🇸
Merritt Island Medical Research, LLC, Merritt Island, Florida, United States
🇺🇸
Boston Center for Memory, Newton, Massachusetts, United States

and more 24 locations

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

Phase 3

Active, not recruiting

Conditions: Alzheimer Disease

Interventions: Drug: Placebo
Drug: Donanemab

First Posted Date: 2020-06-18

Last Posted Date: 2025-04-20

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 1736

Registration Number: NCT04437511

Locations: 🇺🇸
Kaizen Brain Center, La Jolla, California, United States
🇺🇸
Ezy Medical Research, Miami, Florida, United States
🇺🇸
Columbus Memory Center, LLC, Columbus, Georgia, United States

and more 266 locations

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