他尼珠单抗

他尼珠单抗
单克隆抗体
种类	完整抗体
目標	神经生长因子（英语：Nerve growth factor）
臨床資料
其他名稱	RN624
ATC碼	N02BG12 (WHO) ;
识别信息
CAS号	880266-57-9
DrugBank	DB12335 ;
ChemSpider	none;
UNII	EQL0E9GCX1;
化学信息
化学式	C6464H9942N1706O2026S46
摩尔质量	145,445.32 g·mol−1

他尼珠单抗（INN：Tanezumab，开发代号：RN624）是一种针对神经生长因子（英语：Nerve growth factor）的单克隆抗体，通过不同于传统止痛药的新机制来治疗疼痛。^[1]他尼珠单抗由Rinat Neuroscience（英语：Rinat Neuroscience Corporation）公司开发，^[2]并于2006年被辉瑞收购。

2009年，针对骨关节炎引起的膝盖疼痛进行了一项III期试验。^[3]另一项针对骨关节炎髋部疼痛的III期试验^[4]于2010年6月停止，当时一些患者需要进行髋关节置换。^[5]

他尼珠单抗正在进行II期临床试验，用于治疗各种疼痛实体，包括慢性腰痛、骨癌痛和间质性膀胱炎。^[6]

在2012年3月，对于反神经生长因子测试，FDA委员会投票赞成继续开发神经阻断药物，前提是要遵循特定的安全预防措施。^[7]^[8]

2013年发表的一项III期试验发现，对于疼痛性髋骨关节炎，他尼珠单抗优于安慰剂。^[9]

在2019年2月19日，共同开发合作伙伴礼来和辉瑞宣布，使用10毫克坦依唑单抗的治疗达到了主要终点，在16周时相对于安慰剂呈现了统计学上显著的慢性腰背疼痛改善（然而，5毫克组在疼痛方面呈现数值上的改善，但在第16周的分析中未达到统计学显著性与安慰剂相比）。^[10]

参考资料

^ Oo WM, Hunter DJ. Nerve Growth Factor (NGF) Inhibitors and Related Agents for Chronic Musculoskeletal Pain: A Comprehensive Review. BioDrugs. November 2021, 35 (6): 611–641. PMID 34807432. S2CID 244509341. doi:10.1007/s40259-021-00504-8.
^ Shelton DL, Zeller J, Ho WH, Pons J, Rosenthal A. Nerve growth factor mediates hyperalgesia and cachexia in auto-immune arthritis. Pain. July 2005, 116 (1–2): 8–16. PMID 15927377. S2CID 36145654. doi:10.1016/j.pain.2005.03.039.
^ Clinical trial number NCT00733902 for "Tanezumab in Osteoarthritis of the Knee" at ClinicalTrials.gov
^ Clinical trial number NCT00744471 for "Tanezumab in Osteoarthritis Of The Hip" at ClinicalTrials.gov
^ Trials Halted as Pfizer's Tanezumab Shown to Worsen Osteoarthritis. Genetic Engineering & Biotechnology News. 24 June 2010. （原始内容存档于23 January 2013）.
^ Phase II trials involving Tanezumab. ClinicalTrials.gov. U.S. National Library of Medicine. [2023-12-12]. （原始内容存档于2016-03-05）.
^ Tanezumab Arthritis Advisory Committee Briefing Document (PDF). US Food and Drug Administration. 8 February 2012. （原始内容 (PDF)存档于19 January 2017）.
^ Verburg K. Monoclonal Antibodies Targeted Against Nerve Growth Factor For the Treatment of Chronic Pain (PDF). Medicines Development Group, Pfizer Inc. （原始内容 (PDF)存档于9 May 2017）.
^ Brown MT, Murphy FT, Radin DM, Davignon I, Smith MD, West CR. Tanezumab reduces osteoarthritic hip pain: results of a randomized, double-blind, placebo-controlled phase III trial. Arthritis and Rheumatism. July 2013, 65 (7): 1795–1803. PMID 23553790. doi:10.1002/art.37950 .
^ Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain. Seeking Alpha. PR Newswire. February 19, 2019.

外部链接

All registered trials involving Tanezumab （页面存档备份，存于互联网档案馆）

[1] Oo WM, Hunter DJ. Nerve Growth Factor (NGF) Inhibitors and Related Agents for Chronic Musculoskeletal Pain: A Comprehensive Review. BioDrugs. November 2021, 35 (6): 611–641. PMID 34807432. S2CID 244509341. doi:10.1007/s40259-021-00504-8.

[2] Shelton DL, Zeller J, Ho WH, Pons J, Rosenthal A. Nerve growth factor mediates hyperalgesia and cachexia in auto-immune arthritis. Pain. July 2005, 116 (1–2): 8–16. PMID 15927377. S2CID 36145654. doi:10.1016/j.pain.2005.03.039.

[3] Clinical trial number NCT00733902 for "Tanezumab in Osteoarthritis of the Knee" at ClinicalTrials.gov

[4] Clinical trial number NCT00744471 for "Tanezumab in Osteoarthritis Of The Hip" at ClinicalTrials.gov

[5] Trials Halted as Pfizer's Tanezumab Shown to Worsen Osteoarthritis. Genetic Engineering & Biotechnology News. 24 June 2010. （原始内容存档于23 January 2013）.

[6] Phase II trials involving Tanezumab. ClinicalTrials.gov. U.S. National Library of Medicine. [2023-12-12]. （原始内容存档于2016-03-05）.

[7] Tanezumab Arthritis Advisory Committee Briefing Document (PDF). US Food and Drug Administration. 8 February 2012. （原始内容 (PDF)存档于19 January 2017）.

[8] Verburg K. Monoclonal Antibodies Targeted Against Nerve Growth Factor For the Treatment of Chronic Pain (PDF). Medicines Development Group, Pfizer Inc. （原始内容 (PDF)存档于9 May 2017）.

[9] Brown MT, Murphy FT, Radin DM, Davignon I, Smith MD, West CR. Tanezumab reduces osteoarthritic hip pain: results of a randomized, double-blind, placebo-controlled phase III trial. Arthritis and Rheumatism. July 2013, 65 (7): 1795–1803. PMID 23553790. doi:10.1002/art.37950 .

[10] Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain. Seeking Alpha. PR Newswire. February 19, 2019.

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