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度拉糖肽:首次获批

Donanemab: First Approval.

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Drugs. 2024 Oct;84(10):1313-1318. doi: 10.1007/s40265-024-02087-4. Epub 2024 Sep 6.

DOI:10.1007/s40265-024-02087-4
PMID:39237715
Abstract

Donanemab (donanemab-azbt; Kisunla) is an amyloid β-directed antibody developed by Eli Lilly and Company for the treatment of Alzheimer's disease. Donanemab recently received approval in the USA for the treatment of adults with early symptomatic Alzheimer's disease (patients with mild cognitive impairment or mild dementia stage of disease). This article summarizes the milestones in the development of donanemab leading to this first approval for Alzheimer's disease.

摘要

多纳单抗(donanemab-azbt;Kisunla)是由礼来公司开发的一种针对淀粉样β的抗体,用于治疗阿尔茨海默病。多纳单抗最近在美国获得批准,用于治疗早期有症状的阿尔茨海默病患者(轻度认知障碍或疾病轻度痴呆阶段的患者)。本文总结了导致多纳单抗首次获批用于阿尔茨海默病的开发历程中的重要里程碑。

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Monoclonal Antibodies (mAbs) and Proteins: The Biologic Drugs Approved by the Food and Drug Administration (FDA) in 2024.

本文引用的文献

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Donanemab in Japanese Patients with Early Alzheimer's Disease: Subpopulation Analysis of the TRAILBLAZER-ALZ 2 Randomized Trial.多奈单抗用于日本早期阿尔茨海默病患者:TRAILBLAZER-ALZ 2随机试验的亚组分析
Neurol Ther. 2024 Jun;13(3):677-695. doi: 10.1007/s40120-024-00604-x. Epub 2024 Apr 6.
2
Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial.多奈哌齐治疗早期症状性阿尔茨海默病的随机临床试验。
JAMA. 2023 Aug 8;330(6):512-527. doi: 10.1001/jama.2023.13239.
3
Donanemab Population Pharmacokinetics, Amyloid Plaque Reduction, and Safety in Participants with Alzheimer's Disease.
单克隆抗体(mAb)与蛋白质:2024年美国食品药品监督管理局(FDA)批准的生物药物
Biomedicines. 2025 Aug 12;13(8):1962. doi: 10.3390/biomedicines13081962.
4
Exploration of current situation of psychotropic drugs research and development in China based on drug clinical trials.基于药物临床试验的中国精神药物研发现状探索
Front Psychiatry. 2025 Jul 15;16:1599038. doi: 10.3389/fpsyt.2025.1599038. eCollection 2025.
5
Hwanhon Decoction Ameliorates Cognitive Impairment and Suppresses Neuroinflammation in a Chronic Cerebral Hypoperfusion Mouse Model: Involvement of Key Genes Identified by Network Pharmacology.还魂汤改善慢性脑灌注不足小鼠模型的认知障碍并抑制神经炎症:基于网络药理学鉴定关键基因的作用
Genes (Basel). 2025 Jun 26;16(7):746. doi: 10.3390/genes16070746.
6
Alzheimer's Disease Etiology Hypotheses and Therapeutic Strategies: A Perspective.阿尔茨海默病的病因假说与治疗策略:一种观点
Int J Mol Sci. 2025 Jul 20;26(14):6980. doi: 10.3390/ijms26146980.
7
Comparison of visual and analytic methods of Alzheimer's disease pathologic staging.阿尔茨海默病病理分期的视觉与分析方法比较
Alzheimers Dement. 2025 Jul;21(7):e70520. doi: 10.1002/alz.70520.
8
Isomerized Aβ in the brain can distinguish the status of amyloidosis in the Alzheimer's disease spectrum.大脑中的异构化β淀粉样蛋白(Aβ)能够区分阿尔茨海默病谱系中淀粉样变性的状态。
Acta Neuropathol. 2025 Jul 22;150(1):7. doi: 10.1007/s00401-025-02914-2.
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Decoding neuroinflammation in Alzheimer's disease: a multi-omics and AI-driven perspective for precision medicine.解读阿尔茨海默病中的神经炎症:多组学与人工智能驱动的精准医学视角
Front Immunol. 2025 Jun 18;16:1616899. doi: 10.3389/fimmu.2025.1616899. eCollection 2025.
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MAbs. 2025 Dec;17(1):2515414. doi: 10.1080/19420862.2025.2515414. Epub 2025 Jun 26.
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Clin Pharmacol Ther. 2023 Jun;113(6):1258-1267. doi: 10.1002/cpt.2875. Epub 2023 Mar 9.
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Donanemab in Early Alzheimer's Disease.多奈单抗用于早期阿尔茨海默病
N Engl J Med. 2021 May 6;384(18):1691-1704. doi: 10.1056/NEJMoa2100708. Epub 2021 Mar 13.