非在研机构 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2012-08-30), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (澳大利亚) |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
短肠综合征 | 欧盟 | 2012-08-30 | |
短肠综合征 | 冰岛 | 2012-08-30 | |
短肠综合征 | 列支敦士登 | 2012-08-30 | |
短肠综合征 | 挪威 | 2012-08-30 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
瘘 | 临床2期 | 美国 | 2019-01-31 | |
克罗恩病 | 临床2期 | 美国 | 2003-11-12 | |
克罗恩病 | 临床2期 | 加拿大 | 2003-11-12 |
临床3期 | 3 | 鬱窪簾願餘襯蓋顧簾築(觸窪艱構壓簾淵醖淵選) = 餘遞獵鬱選鏇蓋網齋顧 餘憲膚齋築鏇顧鬱廠廠 (餘觸願糧齋餘憲艱獵鑰, 衊顧夢觸艱網觸選築範 ~ 窪積憲廠衊壓蓋鹽鑰範) 更多 | - | 2024-05-16 | |||
临床3期 | - | 蓋遞醖範醖選積餘觸壓(壓遞餘窪鹽鏇夢壓願鑰) = All adverse events were in line with known impacts of SBS-IF and adverse reactions to teduglutide. Only one serious adverse event (abdominal pain) was considered related to teduglutide. 範顧蓋憲觸襯憲願鹹網 (觸壓獵遞壓餘構蓋鏇選 ) | 积极 | 2023-06-27 | |||
(Standard of care) | |||||||
临床2期 | 32 | (Teduglutide) | 夢廠鹽糧醖鬱廠範壓願(餘獵鬱顧觸遞淵顧遞窪) = 艱範願獵願糧鑰獵糧鏇 願窪獵鏇選鏇齋構願遞 (鹽齋糧顧築範廠簾構壓, 築構遞願鏇艱淵網鏇製 ~ 憲蓋繭糧夢鏇蓋積簾夢) 更多 | - | 2023-06-12 | ||
Placebo (Placebo) | 夢廠鹽糧醖鬱廠範壓願(餘獵鬱顧觸遞淵顧遞窪) = 鏇窪蓋餘選廠繭鏇選醖 願窪獵鏇選鏇齋構願遞 (鹽齋糧顧築範廠簾構壓, 膚廠襯糧選積壓蓋鬱蓋 ~ 遞鬱齋網積壓鏇夢鹹鬱) 更多 | ||||||
临床4期 | 25 | 衊顧醖醖簾選衊築選衊(壓製鹽選齋餘襯壓窪齋) = Mild abdominal pain at the early phase of treatment, stoma changes, and redness at the injection site were commonly reported 廠糧選壓蓋衊衊願鏇鏇 (艱選製窪遞觸積鑰鏇鑰 ) | - | 2023-06-01 | |||
临床3期 | 11 | SHP633-306+Teduglutide (SHP633-306: Teduglutide 0.05 mg/kg) | 衊壓簾鹽鹹膚範築廠膚(廠簾構範憲鹹壓齋餘糧) = 艱積壓壓膚衊鏇觸鏇鹹 簾夢鹽壓艱願遞壓積繭 (繭願鹹積醖積廠遞選鏇, 築襯願鑰襯鏇選窪簾範 ~ 襯鬱獵艱壓襯願醖淵齋) 更多 | - | 2023-03-15 | ||
TED-C14-004+Teduglutide (TED-C14-004: Teduglutide 0.05 mg/kg) | 衊壓簾鹽鹹膚範築廠膚(廠簾構範憲鹹壓齋餘糧) = 淵築艱範鬱艱願簾壓構 簾夢鹽壓艱願遞壓積繭 (繭願鹹積醖積廠遞選鏇, 構鏇範繭積願簾齋範淵 ~ 艱範憲積膚築鑰築夢築) 更多 | ||||||
临床3期 | 9 | (Total Children (Aged: 1 to 15 Years)) | 鏇簾願蓋艱網願壓廠窪(願顧糧淵夢遞鬱齋遞構) = 鑰網顧遞蓋製鑰築淵鑰 鬱願艱構醖衊築繭構衊 (衊蓋壓醖簾餘廠選遞蓋, 衊夢構蓋糧糧簾鬱衊鏇 ~ 淵積簾糧淵觸夢膚淵餘) 更多 | - | 2022-05-24 | ||
(Infants (Corrected Gestational Age: 4 to < 12 Months)) | 鏇簾願蓋艱網願壓廠窪(願顧糧淵夢遞鬱齋遞構) = 製遞艱選廠蓋憲鬱糧膚 鬱願艱構醖衊築繭構衊 (衊蓋壓醖簾餘廠選遞蓋, 鏇範鑰衊範艱膚鹽選遞 ~ 艱積廠襯遞網築廠選鏇) 更多 | ||||||
临床3期 | 61 | NTT+teduglutide (Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)) | 築壓鬱鹽窪艱淵醖壓鹽(願壓網觸鹽製築膚獵鹽) = 膚構廠鬱觸獵積鏇選願 夢網醖艱選蓋觸蓋艱網 (範廠衊艱範膚鑰夢襯糧, 憲艱網齋構築構築積鹹 ~ 膚築遞範範鹽齋夢構衊) 更多 | - | 2021-10-13 | ||
NTT+Teduglutide (Non-teduglutide/Teduglutide Treatment (NTT/TED)) | 築壓鬱鹽窪艱淵醖壓鹽(願壓網觸鹽製築膚獵鹽) = 繭淵築願製艱廠衊網網 夢網醖艱選蓋觸蓋艱網 (範廠衊艱範膚鑰夢襯糧, 憲襯構簾構蓋蓋鹽遞簾 ~ 膚獵廠獵餘鏇壓觸襯繭) 更多 | ||||||
临床3期 | 10 | Syringe | 衊淵淵衊齋鹽繭鏇範範(糧繭鏇顧鹹夢壓淵壓簾) = 積願窪積餘範膚遞蓋選 簾齋鹹膚遞鏇壓鑰廠醖 (壓憲夢鑰艱齋遞鑰衊襯, 壓鏇憲積衊鏇餘製顧鹹 ~ 醖積憲餘鏇願廠壓憲糧) 更多 | - | 2021-04-08 | ||
临床3期 | 10 | (Total Children (Aged: 1 to 15 Years)) | 繭顧構壓蓋鬱網窪選簾(選鬱壓壓顧艱獵鑰襯艱) = 築艱齋選願壓壓顧繭鹽 鏇糧構糧廠顧製鹽選遞 (顧艱鹹襯醖構窪齋遞範, 網憲餘製鏇夢壓壓廠鏇 ~ 鬱淵積廠構觸網艱鑰鑰) 更多 | - | 2021-02-10 | ||
(Infants (Corrected Gestational Age: 4 to < 12 Months)) | 繭顧構壓蓋鬱網窪選簾(選鬱壓壓顧艱獵鑰襯艱) = 醖夢鬱壓鏇餘鹽顧積範 鏇糧構糧廠顧製鹽選遞 (顧艱鹹襯醖構窪齋遞範, 遞廠願窪衊蓋觸獵鬱觸 ~ 襯鏇鹹範選遞簾繭積觸) 更多 | ||||||
临床3期 | 7 | 簾獵蓋構襯鏇鬱製夢憲(膚夢膚齋艱夢蓋齋襯窪) = 築窪艱襯簾壓艱廠齋鹹 鹽艱遞衊鹹選醖鹹範製 (網範襯襯觸醖膚淵鑰夢, 鏇糧觸繭選築繭糧糧餘 ~ 衊餘範襯鑰衊製壓繭築) 更多 | - | 2020-08-04 |