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Donanemab

Generic Name
Donanemab
Brand Names
Kisunla, 记能达
Drug Type
Biotech
CAS Number
1931944-80-7
Unique Ingredient Identifier
1ADB65P1KK

Overview

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.

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。

Associated Conditions

No associated conditions information available.

FDA Approved Products

No FDA products found for this drug

Singapore Approved Products

Lormalzi Concentrate for Solution for Infusion 350mg/20mL
Manufacturer:Lilly France
Form:INFUSION, SOLUTION CONCENTRATE
Strength:350mg/20mL
Online:Yes
Approved: 2025/03/11
Approval:SIN17201P

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