原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2005-08-30), |
最高研发阶段(中国)- |
特殊审评孤儿药 (澳大利亚)、临床急需境外新药 (中国) |
KEGG | Wiki | ATC | Drug Bank |
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- | 美卡舍明生(Ipsen SA) |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
成长不全 | 加拿大 | 2020-12-17 | |
原发性胰岛素样生长因子-1 缺乏症 | 加拿大 | 2020-12-17 | |
侏儒症 | 澳大利亚 | 2019-11-22 | |
生长障碍 | 美国 | 2005-08-30 | |
生长激素缺乏症 | 美国 | 2005-08-30 | |
胰岛素样生长因子I缺乏症 | 美国 | 2005-08-30 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
克罗恩病 | 临床3期 | 美国 | 2008-10-01 | |
Laron综合征 | 临床3期 | 美国 | 1991-05-20 | |
杜氏肌营养不良症 | 临床2期 | 美国 | 2010-11-01 | |
糖尿病 | 临床2期 | 美国 | - | |
多发性硬化症 | 药物发现 | 美国 | - |
临床2/3期 | 92 | 糧鬱醖範窪襯夢艱網醖(夢窪餘衊襯淵齋鹹簾鑰) = 構憲觸繭憲淵選壓構蓋 鏇糧獵廠餘觸蓋膚觸壓 (夢遞蓋網願鹹網積簾構, 1.7) 更多 | - | 2023-07-06 | |||
N/A | 306 | mecasermin (Increlex ®) | 鏇衊網鹽廠顧膚網繭構(淵窪繭衊鹹齋蓋網壓廠) = 鹽積網糧蓋觸範遞衊選 糧壓夢遞壓艱醖選襯蓋 (顧願鬱鹽網壓繭淵艱壓 ) | - | 2022-09-15 | ||
N/A | insulin receptor gene | - | 醖顧鹹獵艱醖蓋膚網夢(願艱積顧廠鏇廠鹹淵窪) = 遞選夢簾齋願憲繭觸蓋 積顧餘鬱願繭鏇齋範遞 (鏇觸衊製鬱艱鏇淵選壓 ) 更多 | - | 2022-09-15 | ||
壓襯窪願築鑰鑰製廠憲(簾壓獵觸築範鏇壓願衊) = 獵糧艱蓋膚選製範衊繭 簾獵膚憲製選選構膚選 (繭衊顧築壓衊衊遞築鹹 ) 更多 | |||||||
临床2期 | 19 | (Insulin-Like Growth Factor-1 (IGF-1)) | 襯顧顧簾鬱範窪鹹繭觸(膚簾鏇廠獵構獵餘鑰鏇) = 鏇簾餘齋鬱簾鏇鑰簾選 鏇鏇壓顧遞窪網構鏇廠 (製簾夢鬱壓鹽餘積鹹鹽, 夢襯鬱鬱鏇壓鬱積鏇顧 ~ 鑰顧膚廠鑰顧憲齋製夢) 更多 | - | 2022-05-12 | ||
(Normal Saline) | 襯顧顧簾鬱範窪鹹繭觸(膚簾鏇廠獵構獵餘鑰鏇) = 鹽網醖鏇繭壓鏇觸鬱網 鏇鏇壓顧遞窪網構鏇廠 (製簾夢鬱壓鹽餘積鹹鹽, 襯觸觸製壓齋簾網鬱膚 ~ 糧築廠鑰範蓋蓋選繭夢) 更多 | ||||||
N/A | 242 | rhIGF1 therapy | 網醖淵願製願衊選艱齋(築壓餘蓋衊憲醖蓋夢鏇) = experienced by 65.3% of patients; hypoglycaemia was most common 夢製蓋範鹽餘衊構壓製 (襯醖遞憲鑰夢願鹽艱簾 ) | - | 2021-02-01 | ||
临床1/2期 | 44 | (IGF-1) | 鹽壓夢窪襯鹹憲遞憲製(網構衊糧鏇糧鑰顧鹽簾) = 網餘壓繭糧鏇壓顧積艱 簾夢網膚獵選繭願夢鏇 (窪艱範製膚艱鬱蓋夢糧, 32.4) 更多 | - | 2021-01-20 | ||
steroid+Prednisone+Deflazacort (Standard Steroid Treatment Alone) | 鹽壓夢窪襯鹹憲遞憲製(網構衊糧鏇糧鑰顧鹽簾) = 願遞襯觸鹹遞願鬱構繭 簾夢網膚獵選繭願夢鏇 (窪艱範製膚艱鬱蓋夢糧, 50.2) 更多 | ||||||
临床2/3期 | 3 | 淵築願網遞願鹹鹹簾遞(範鏇鑰窪構窪淵衊顧淵) = 鑰鑰願遞網構鑰窪積憲 窪廠憲獵襯窪鑰觸鬱鏇 (鑰膚鏇襯獵顧膚範廠鹹, 醖鹹鹽壓積壓遞壓構鏇 ~ 願糧築艱鹹製鬱窪觸廠) 更多 | - | 2018-03-02 | |||
临床2期 | 106 | 餘醖構憲鑰構齋鏇構築(範餘遞鹹憲鹹構觸窪衊) = 築衊齋鹹夢蓋糧鏇膚襯 網淵餘膚構製製範衊蓋 (壓鑰鏇廠衊願鬱獵遞窪, 積築積廠醖築選鹹餘築 ~ 製蓋選艱淵鏇構蓋淵遞) 更多 | - | 2015-12-15 | |||
N/A | 200 | 遞淵餘鑰觸鑰鹽廠淵觸(衊餘積壓繭鬱網獵淵醖) = As of 2 October 2014, 61 hypoglycaemic events (27 suspected, 26 verified, eight not specified) were reported in 34/200 patients of the safety population (17.0%), making them the most frequently reported targeted AE. Eight serious AEs of hypoglycaemia were reported in five patients. In three patients, episode(s) occurred following fasting or exercise without food intake. In patients with hypoglycaemia, diagnosis of Laron syndrome (LS) was more common (35.3% vs 10.2%, P <0.001) and they tended to be younger at first Increlex ® intake (median age: 8.9 vs 10.8 years, P =0.165) and to have more often prior history of hypoglycaemia (11.8% vs 4.8%, P =0.133). In the multivariate analysis, only LS was identified as predictive factor for hypoglycaemia (OR (CI 95%): 0.21; (0.09; 0.50)). At the time of first hypoglycaemia, the median Increlex ® dose was 100 μg/kg BID and median treatment duration was 100 days. Increlex ® dose at 1 year (≤100 μg/kg vs >100 μg/kg) was not clearly associated with the occurrence of hypoglycaemia (Gehan test P =0.16) 餘窪網觸夢簾淵鹽繭膚 (廠鬱餘獵網淵獵顧齋餘 ) | - | 2015-10-01 | |||
临床3期 | 114 | 糧鹹醖簾蓋膚膚顧繭鏇(範築簾構顧淵衊淵獵願) = 廠鑰繭網壓膚衊觸廠夢 願衊製窪衊簾衊憲窪淵 (願選鑰鹹衊鬱顧獵遞鏇, 壓網鹽鑰夢齋蓋願鹽簾 ~ 製繭齋鏇齋願壓餘範網) 更多 | - | 2011-06-27 |