多奈单抗

多奈單抗
Donanemab
单克隆抗体
种类	完整抗体
目標	β澱粉樣蛋白
臨床資料
其他名稱	LY3002813
ATC碼	N06DX05 (WHO) ;
法律規範狀態
法律規範	試驗中;
识别信息
CAS号	1931944-80-7
UNII	1ADB65P1KK;
KEGG	D11500;
化学信息
化学式	C6452H10038N1708O2013S42
摩尔质量	145087.70

多奈单抗（英語：Donanemab）是美国药企礼来公司正在研发的阿尔茨海默病抗体药物，可輕微減緩阿茲海默症的發展，但無法逆轉症狀。^[1]^[2]

歷史

2023年7月17日，礼来公布了该药物的完整3期临床试验结果^[3]。结果显示，对淀粉样蛋白阳性、有症状的早期阿尔茨海默病患者而言，多奈单抗显著降低了他们的認知功能下降，降低了疾病进展的风险^[4]。亚组分析结果表明，处于疾病早期的患者获益更多，与安慰剂组相比，减缓了60%的认知功能下降^[4]。

礼来公司表示，已于2023年第二季度向美国食品药品监督管理局（FDA）完成上市申请提交^[5]。2024年6月10日，獲得美國食品藥物管理局顧問一致支持，美國食藥局預計於年底前做出最終決定。^[1]^[2]

作用機制

近年來透過顯微影像技術，認為細胞外過量的β澱粉樣蛋白與阿茲海默症的發展有關。^[6]過多的β澱粉樣蛋白會在大腦的某些部分形成斑塊，進而干擾神經傳導。^[7]多奈單抗藉攻擊可溶性和不溶性的斑塊積聚，以減緩阿茲海默症的發展。^[8]

参考来源

^ ^1.0 ^1.1 Kolata, Gina; Belluck, Pam. Advisory Panel of Experts Endorses F.D.A. Approval of New Alzheimer’s Drug. The New York Times. 2024-06-10 [2024-06-23]. （原始内容存档于2024-06-27）（英语）.
^ ^2.0 ^2.1 Reardon, Sara. Alzheimer’s drug with modest benefits wins backing of FDA advisers. Nature. 2024-06-10. doi:10.1038/d41586-024-01726-w （英语）.
^ Results from Lilly's Landmark Phase 3 Trial of Donanemab Presented at Alzheimer's Association Conference and Published in JAMA. Eli Lilly and Company. 2023-07-17 [2023-07-22]. （原始内容存档于2023-11-14）（英语）.
^ ^4.0 ^4.1 Sims, John R.; Zimmer, Jennifer A.; Evans, Cynthia D.; Lu, Ming; Ardayfio, Paul; Sparks, JonDavid; Wessels, Alette M.; Shcherbinin, Sergey; Wang, Hong; Monkul Nery, Emel Serap; Collins, Emily C. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023-07-17. ISSN 0098-7484. doi:10.1001/jama.2023.13239 （英语）.
^ Lilly's Donanemab Significantly Slowed Cognitive and Functional Decline in Phase 3 Study of Early Alzheimer's Disease. Eli Lilly and Company. 2023-05-03 [2023-07-22]. （原始内容存档于2023-12-23）（英语）.
^ Long, Justin M.; Holtzman, David M. Alzheimer Disease: An Update on Pathobiology and Treatment Strategies. Cell. 2019-10, 179 (2): 312–339. doi:10.1016/j.cell.2019.09.001 （英语）.
^ DeMattos, Ronald B.; Lu, Jirong; Tang, Ying; Racke, Margaret M.; DeLong, Cindy A.; Tzaferis, John A.; Hole, Justin T.; Forster, Beth M.; McDonnell, Peter C.; Liu, Feng; Kinley, Robert D.; Jordan, William H.; Hutton, Michael L. A Plaque-Specific Antibody Clears Existing β-amyloid Plaques in Alzheimer's Disease Mice. Neuron. 2012-12, 76 (5): 908–920. doi:10.1016/j.neuron.2012.10.029 （英语）.
^ Gallardo, Gilbert; Holtzman, David M. Amyloid-β and Tau at the Crossroads of Alzheimer’s Disease. Tau Biology. 2019, 1184: 187–203. doi:10.1007/978-981-32-9358-8_16 （英语）.

这是一篇與药学相關的小作品。您可以通过编辑或修订扩充其内容。

[nyt-1] 1.0 ^1.1 Kolata, Gina; Belluck, Pam. Advisory Panel of Experts Endorses F.D.A. Approval of New Alzheimer’s Drug. The New York Times. 2024-06-10 [2024-06-23]. （原始内容存档于2024-06-27）（英语）.

[nature-2] 2.0 ^2.1 Reardon, Sara. Alzheimer’s drug with modest benefits wins backing of FDA advisers. Nature. 2024-06-10. doi:10.1038/d41586-024-01726-w （英语）.

[3] Results from Lilly's Landmark Phase 3 Trial of Donanemab Presented at Alzheimer's Association Conference and Published in JAMA. Eli Lilly and Company. 2023-07-17 [2023-07-22]. （原始内容存档于2023-11-14）（英语）.

[:0-4] 4.0 ^4.1 Sims, John R.; Zimmer, Jennifer A.; Evans, Cynthia D.; Lu, Ming; Ardayfio, Paul; Sparks, JonDavid; Wessels, Alette M.; Shcherbinin, Sergey; Wang, Hong; Monkul Nery, Emel Serap; Collins, Emily C. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023-07-17. ISSN 0098-7484. doi:10.1001/jama.2023.13239 （英语）.

[5] Lilly's Donanemab Significantly Slowed Cognitive and Functional Decline in Phase 3 Study of Early Alzheimer's Disease. Eli Lilly and Company. 2023-05-03 [2023-07-22]. （原始内容存档于2023-12-23）（英语）.

[6] Long, Justin M.; Holtzman, David M. Alzheimer Disease: An Update on Pathobiology and Treatment Strategies. Cell. 2019-10, 179 (2): 312–339. doi:10.1016/j.cell.2019.09.001 （英语）.

[7] DeMattos, Ronald B.; Lu, Jirong; Tang, Ying; Racke, Margaret M.; DeLong, Cindy A.; Tzaferis, John A.; Hole, Justin T.; Forster, Beth M.; McDonnell, Peter C.; Liu, Feng; Kinley, Robert D.; Jordan, William H.; Hutton, Michael L. A Plaque-Specific Antibody Clears Existing β-amyloid Plaques in Alzheimer's Disease Mice. Neuron. 2012-12, 76 (5): 908–920. doi:10.1016/j.neuron.2012.10.029 （英语）.

[8] Gallardo, Gilbert; Holtzman, David M. Amyloid-β and Tau at the Crossroads of Alzheimer’s Disease. Tau Biology. 2019, 1184: 187–203. doi:10.1007/978-981-32-9358-8_16 （英语）.

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