他尼珠單抗

他尼珠單抗
單克隆抗體
種類	完整抗體
目標	神經生長因子（英語：Nerve growth factor）
臨床資料
其他名稱	RN624
ATC碼	N02BG12 (WHO) ;
識別資訊
CAS號	880266-57-9
DrugBank	DB12335 ;
ChemSpider	none;
UNII	EQL0E9GCX1;
化學資訊
化學式	C6464H9942N1706O2026S46
摩爾質量	145,445.32 g·mol−1

他尼珠單抗（INN：Tanezumab，開發代號：RN624）是一種針對神經生長因子（英語：Nerve growth factor）的單克隆抗體，通過不同於傳統止痛藥的新機制來治療疼痛。^[1]他尼珠單抗由Rinat Neuroscience（英語：Rinat Neuroscience Corporation）公司開發，^[2]並於2006年被輝瑞收購。

2009年，針對骨關節炎引起的膝蓋疼痛進行了一項III期試驗。^[3]另一項針對骨關節炎髖部疼痛的III期試驗^[4]於2010年6月停止，當時一些患者需要進行髖關節置換。^[5]

他尼珠單抗正在進行II期臨床試驗，用於治療各種疼痛實體，包括慢性腰痛、骨癌痛和間質性膀胱炎。^[6]

在2012年3月，對於反神經生長因子測試，FDA委員會投票贊成繼續開發神經阻斷藥物，前提是要遵循特定的安全預防措施。^[7]^[8]

2013年發表的一項III期試驗發現，對於疼痛性髖骨關節炎，他尼珠單抗優於安慰劑。^[9]

在2019年2月19日，共同開發合作夥伴禮來和輝瑞宣布，使用10毫克坦依唑單抗的治療達到了主要終點，在16周時相對於安慰劑呈現了統計學上顯著的慢性腰背疼痛改善（然而，5毫克組在疼痛方面呈現數值上的改善，但在第16周的分析中未達到統計學顯著性與安慰劑相比）。^[10]

參考資料

^ 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. （原始內容存檔於23 January 2013）.
^ Phase II trials involving Tanezumab. ClinicalTrials.gov. U.S. National Library of Medicine. [2023-12-12]. （原始內容存檔於2016-03-05）.
^ Tanezumab Arthritis Advisory Committee Briefing Document (PDF). US Food and Drug Administration. 8 February 2012. （原始內容 (PDF)存檔於19 January 2017）.
^ Verburg K. Monoclonal Antibodies Targeted Against Nerve Growth Factor For the Treatment of Chronic Pain (PDF). Medicines Development Group, Pfizer Inc. （原始內容 (PDF)存檔於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.

外部連結

All registered trials involving Tanezumab （頁面存檔備份，存於網際網路檔案館）

[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. （原始內容存檔於23 January 2013）.

[6] Phase II trials involving Tanezumab. ClinicalTrials.gov. U.S. National Library of Medicine. [2023-12-12]. （原始內容存檔於2016-03-05）.

[7] Tanezumab Arthritis Advisory Committee Briefing Document (PDF). US Food and Drug Administration. 8 February 2012. （原始內容 (PDF)存檔於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. （原始內容 (PDF)存檔於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.

[1]

[2]

[3]

[4]

[5]

[6]

[7]

[8]

[9]

[10]