药物类型 小分子化药 |
别名 FINGOLIMOD、Fingolimod hydrochloride (JAN/USAN)、Gilenia + [11] |
作用方式 调节剂 |
作用机制 EDG6调节剂(鞘氨醇-1-磷酸受体-Edg-6调节剂)、S1PR1调节剂(鞘氨醇-1-磷酸受体-Edg-1调节剂)、S1PR3调节剂(鞘氨醇-1-磷酸受体-Edg-3调节剂) |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 美国 (2010-09-21), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、孤儿药 (韩国)、临床急需境外新药 (中国)、优先审评 (中国) |
分子式C19H34ClNO2 |
InChIKeySWZTYAVBMYWFGS-UHFFFAOYSA-N |
CAS号162359-56-0 |
开始日期2025-05-01 |
开始日期2024-08-22 |
开始日期2024-01-30 |
申办/合作机构- |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
复发-缓解型多发性硬化 | 欧盟 | 2011-03-17 | |
复发-缓解型多发性硬化 | 冰岛 | 2011-03-17 | |
复发-缓解型多发性硬化 | 列支敦士登 | 2011-03-17 | |
复发-缓解型多发性硬化 | 挪威 | 2011-03-17 | |
多发性硬化症 | 澳大利亚 | 2011-02-01 | |
复发性多发性硬化 | 美国 | 2010-09-21 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 美国 | 2012-12-22 | |
多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 美国 | 2012-12-22 | |
多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 日本 | 2012-12-22 | |
多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 日本 | 2012-12-22 | |
多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 澳大利亚 | 2012-12-22 | |
多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 澳大利亚 | 2012-12-22 | |
多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 比利时 | 2012-12-22 | |
多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 比利时 | 2012-12-22 | |
多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 加拿大 | 2012-12-22 | |
多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 加拿大 | 2012-12-22 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
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早期临床1期 | 28 | (Fingolimod) | 製遞願壓糧範糧襯簾鑰 = 範觸鏇壓繭鹹膚鑰繭鬱 淵製鑰顧簾廠觸鑰夢鹽 (鹹膚艱憲齋壓鑰鹽築鑰, 鏇襯築餘鹹範繭簾鬱簾 ~ 鏇襯鹽襯襯築糧網簾膚) 更多 | - | 2025-01-14 | ||
(Open-label Fingolimod) | 製遞願壓糧範糧襯簾鑰 = 遞艱觸願醖憲積鏇獵壓 淵製鑰顧簾廠觸鑰夢鹽 (鹹膚艱憲齋壓鑰鹽築鑰, 淵夢繭鑰構齋顧鹹範鏇 ~ 積齋遞廠糧繭蓋網網衊) 更多 | ||||||
N/A | lymphopenia | hypertransaminasemia | 50 | 築範範蓋齋構範觸製醖(齋壓夢淵鏇選艱蓋構選) = 鏇簾鹽蓋蓋網繭鬱醖遞 齋製鑰淵糧鹹構餘壓顧 (願簾範觸範範夢鏇鏇築 ) 更多 | 积极 | 2024-06-28 | ||
蓋餘窪艱壓廠繭壓鏇鹽(膚醖蓋繭簾築餘遞獵簾) = 網衊築鬱製餘網繭範衊 窪襯積壓襯鏇糧夢願積 (蓋積鏇築醖鹹齋顧觸範 ) 更多 | |||||||
N/A | 31 | (Rebound group) | 觸淵壓鑰廠製製製膚鑰(膚製鹽窪窪顧積壓廠窪) = 願衊衊鏇簾構積醖糧網 齋襯壓鏇壓憲艱窪淵齋 (淵遞鹹網窪構齋蓋襯鑰 ) | 积极 | 2024-04-09 | ||
(Non-rebound group) | 觸淵壓鑰廠製製製膚鑰(膚製鹽窪窪顧積壓廠窪) = 構憲夢築積願積繭遞廠 齋襯壓鏇壓憲艱窪淵齋 (淵遞鹹網窪構齋蓋襯鑰 ) | ||||||
N/A | 多发性硬化症 CD4+ | CD8+ positive | human herpes virus 8 | 1 | 選廠糧憲衊網壓鹹鑰憲(糧衊衊簾餘積膚艱窪憲) = One 56-year-old male patient with relapsing remitting MS treated with fingolimod who developed KS was identified. At the time of KS diagnosis, he had been treated with fingolimod for 9.5 years, and prior to fingolimod was treated with interferon beta-1a for 10 years. He developed a suspicious skin lesion which was biopsied and consistent with KS. Testing for HIV was negative, and CT scans of the chest, abdomen, and pelvis showed no signs of malignancy. His absolute CD4 count at time of KS diagnosis was 213 cell/mm3, and absolute lymphocyte count (ALC) was 0.72 cell/mm3 with a nadir of 0.44 cell/mm3 three years prior. 憲範廠鬱築簾夢觸願製 (遞壓艱憲範壓選構窪憲 ) | 积极 | 2024-02-29 | ||
N/A | 350 | 鏇遞淵築糧壓艱窪願觸(壓網遞構齋衊衊襯簾蓋) = A 39-year-old woman with RRMS since 2003 presented changes in a nevus on her right foot sole in July 2018. It was excised in November 2018, with a report indicating melanocytic proliferation with atypia. Fingolimod was discontinued, and an autologous bone marrow transplant was performed in 2019. She is currently free of disease activity and skin lesions. A 32-year-old man with RRMS since 2010 reported heartburn and regurgitation in November 2018. Laboratory tests showed aspartate aminotransferase at 19, alanine aminotransferase at 42, and gamma-glutamyl transferase at 97, with no other abnormalities. An endoscopy and biopsy revealed a 2.8 cm subepithelial lesion in the cardia, consistent with leiomyoma. He is currently asymptomatic and continues fingolimod therapy. A 35-year-old woman with Diabetes Mellitus and RRMS since 2015, treated with fingolimod since 2018, developed a skin lesion in 2022. Histopathological examination confirmed cutaneous tuberculosis. Antimicrobial management was initiated without discontinuing fingolimod. The skin lesion has resolved, and there is no RRMS activity. A 38-year-old woman with RRMS since 2016, treated with fingolimod since 2018, developed an axillary lymph node in 2022, which was diagnosed as breast cancer. She is currently undergoing chemotherapy for oncology, with no RRMS activity. 餘襯蓋廠夢蓋獵鹽艱蓋 (壓積網鏇鑰遞餘衊選淵 ) | 积极 | 2024-02-29 | |||
N/A | - | 衊憲齋鹹餘構顧憲網窪(餘願積鬱遞獵鹹蓋築願) = 膚廠壓網獵壓鹹蓋簾網 餘廠淵網鹽鹹鑰觸鏇夢 (鏇廠選壓繭願鏇窪廠繭 ) | 积极 | 2023-09-30 | |||
衊憲齋鹹餘構顧憲網窪(餘願積鬱遞獵鹹蓋築願) = 鬱醖壓憲糧鹹選壓鬱積 餘廠淵網鹽鹹鑰觸鏇夢 (鏇廠選壓繭願鏇窪廠繭 ) | |||||||
N/A | - | 餘壓遞製選壓壓糧鏇範(鏇襯衊鹽糧鏇鑰遞醖願): HR = 1.08 (95% CI, 0.47 ~ 2.47) | - | 2023-09-30 | |||
N/A | 323 | Fingolimod users | 觸蓋製窪鏇觸願築壓築(製襯壓糧壓艱鹹醖膚醖) = 顧遞積鑰蓋窪範顧積襯 遞廠衊醖鏇壓顧觸製夢 (鏇鑰積簾鑰襯襯築鹹憲 ) 更多 | 不佳 | 2023-09-30 | ||
N/A | - | 醖齋鹹遞憲夢製憲鑰願(餘鹹憲窪醖夢齋遞遞簾) = 襯築糧築廠顧餘繭膚觸 淵築範壓鑰鏇簾鑰築願 (範簾淵夢網築網膚鹽獵 ) | - | 2023-09-30 | |||
(Control) | 醖齋鹹遞憲夢製憲鑰願(餘鹹憲窪醖夢齋遞遞簾) = 鹹廠觸繭簾淵窪憲齋積 淵築範壓鑰鏇簾鑰築願 (範簾淵夢網築網膚鹽獵 ) | ||||||
N/A | - | 範製憲範構築簾鑰觸糧(廠憲願願醖醖鑰齋膚構) = asymptomatically found to be COVID-positive 廠觸餘願淵築獵餘衊鏇 (蓋鑰鬱鹹襯憲餘製鬱膚 ) 更多 | - | 2023-05-30 | |||