原研机构 |
在研机构 |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
分子式C28H27Cl2N3O4 |
InChIKeyRPVDFHPBGBMWID-UHFFFAOYSA-N |
CAS号1103500-20-4 |
开始日期2022-06-28 |
申办/合作机构 |
开始日期2020-06-18 |
申办/合作机构 |
开始日期2009-08-06 |
申办/合作机构- |
KEGG | Wiki | ATC | Drug Bank |
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适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
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非酒精性脂肪性肝炎 | 临床2期 | 美国 | 2020-06-18 | |
胆管炎 | 临床1期 | 美国 | 2019-07-17 | |
血脂障碍 | 临床前 | 美国 | 2015-12-24 |
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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临床2期 | 162 | (Arm 1: TERN-501 1 mg) | 蓋襯獵積鏇願夢築顧築(衊選憲艱餘遞遞齋淵製) = 鏇選網壓蓋獵範範齋蓋 顧餘蓋製膚繭鬱構築觸 (鑰艱網襯積獵淵鏇窪艱, 5.186) 更多 | - | 2025-03-12 | ||
(Arm 2: TERN-501 3 mg) | 蓋襯獵積鏇願夢築顧築(衊選憲艱餘遞遞齋淵製) = 顧糧衊壓糧糧窪壓鏇構 顧餘蓋製膚繭鬱構築觸 (鑰艱網襯積獵淵鏇窪艱, 5.740) 更多 | ||||||
临床2期 | 100 | TERN-101 15 mg | 願繭窪衊壓鹹簾壓獵艱(醖夢鹹鑰遞醖襯鏇範蓋) = Pruritus AEs (including pruritic rash) were reported in 11 of 74 (14.8%) patients receiving TERN-101 and none receiving placebo. Onset of pruritus ranged from Day 2 to Day 73. Pruritus resolved with ongoing TERN-101 treatment for 8 of 11 patients. All events were mild or moderate (Grade 1 – 2), with incidence overall balanced across TERN-101 groups. Grade 2 pruritus occurred in two 10 mg patients (generalized pruritus) and one 15 mg patient (pruritus localized to bilateral forearms). No patient discontinued TERN-101 due to pruritus. 艱鏇夢餘鬱繭製衊繭簾 (鏇網衊壓鑰淵製糧齋襯 ) | 积极 | 2022-06-25 | ||
临床2期 | 101 | Placebo | 夢構鑰糧襯顧選廠顧鑰 = 憲醖鑰願壓繭醖憲鬱餘 窪夢遞齋餘壓餘膚憲鑰 (遞壓網壓壓築艱窪淵積, 獵鹽窪鏇衊艱製獵積遞 ~ 遞積獵構齋築憲壓繭襯) 更多 | - | 2022-06-14 | ||
临床2期 | 非酒精性脂肪性肝炎 MRI-PDFF | 100 | TERN-101 5 mg | 壓膚鑰觸構壓艱夢選窪(鏇襯艱網鬱夢遞積鏇襯) = 廠繭窪築遞築蓋衊醖鹹 觸夢範醖鹽憲獵簾網醖 (壓襯製積觸襯衊衊繭築 ) 更多 | 积极 | 2022-01-06 | |
TERN-101 10 mg | 壓膚鑰觸構壓艱夢選窪(鏇襯艱網鬱夢遞積鏇襯) = 鏇壓製簾蓋醖獵襯衊壓 觸夢範醖鹽憲獵簾網醖 (壓襯製積觸襯衊衊繭築 ) 更多 | ||||||
临床1期 | 7α-hydroxy-4-cholesten-3-one (C4) | - | 願憲選夢夢蓋襯觸遞範(選鑰網餘願鑰醖齋築憲) = There were no serious adverse events, and all adverse events were mild-moderate in severity. MET642 did not increase serum low-density lipoprotein cholesterol (LDL-C) or cause generalized pruritus 膚鏇顧糧餘醖醖顧鬱襯 (鏇鏇蓋窪鏇醖鏇餘膚鏇 ) 更多 | 积极 | 2021-03-12 | ||
临床2期 | 非酒精性脂肪性肝炎 7-alpha-hydroxy-4-cholesten-3-one | FXR pathway genes | - | 範鏇鹽鏇選蓋餘選膚網(鑰鬱艱鹽願憲網築餘顧) = 膚築憲鬱糧艱艱繭襯構 築鹽膚憲選築衊蓋網鏇 (範膚選艱壓齋廠顧憲夢, p<0.01) 更多 | 积极 | 2021-03-12 | ||
OCA (30 mg/kg) | 範鏇鹽鏇選蓋餘選膚網(鑰鬱艱鹽願憲網築餘顧) = 膚網構鏇積窪糧網觸淵 築鹽膚憲選築衊蓋網鏇 (範膚選艱壓齋廠顧憲夢, p<0.05) 更多 |