在研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2024-06-26), |
最高研发阶段(中国)临床3期 |
特殊审评- |
分子式C26H31N5O4 |
InChIKeyCSOBIBXVIYAXFM-UHFFFAOYSA-N |
CAS号298680-25-8 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
慢性阻塞性肺疾病 | 美国 | 2024-06-26 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
慢性阻塞性肺疾病 | 临床3期 | 保加利亚 | 2020-09-22 | |
慢性阻塞性肺疾病 | 临床3期 | 斯洛伐克 | 2020-09-22 | |
慢性阻塞性肺疾病 | 临床3期 | 波兰 | 2020-09-22 | |
慢性阻塞性肺疾病 | 临床3期 | 西班牙 | 2020-09-22 | |
慢性阻塞性肺疾病 | 临床3期 | 匈牙利 | 2020-09-22 | |
过敏性鼻炎 | 临床2期 | 荷兰 | - | |
慢性阻塞性肺疾病 | 药物发现 | 加拿大 | 2020-09-22 | |
慢性阻塞性肺疾病 | 药物发现 | 丹麦 | 2020-09-22 | |
慢性阻塞性肺疾病 | 药物发现 | 爱沙尼亚 | 2020-09-22 | |
慢性阻塞性肺疾病 | 药物发现 | 比利时 | 2020-09-22 |
临床3期 | 1,553 | (ENHANCE-1) | (廠願鹹夢繭鏇廠簾築鏇) = 繭憲鏇艱窪廠壓醖鏇鏇 鑰夢遞構願糧艱艱築窪 (鹹鹹願憲衊顧遞鑰積積, 25 ~ 97) 更多 | 积极 | 2024-06-26 | ||
Placebo (ENHANCE-1) | (廠願鹹夢繭鏇廠簾築鏇) = 選壓製鹽窪積糧膚壓網 鑰夢遞構願糧艱艱築窪 (鹹鹹願憲衊顧遞鑰積積, -64 ~ 13) 更多 | ||||||
临床3期 | 760 | ENHANCE-1 was a 24-week (+48-wk subset), multi-center, randomized, double-blind, placebo-controlled trial to evaluate nebulized ensifentrine-3mg twice-daily (randomized 5:3) in subjects 40-80 years with symptomatic moderate-to-severe COPD (post-bronchodilator FEV1 30–70% predicted, FEV1/FVC ratio <0.7, >2mMRC), and smoking history >10 pack-years. Primary endpoint was change from baseline to Week 12 average FEV1 AUC0-12h. Healthcare resource utilization (HRU) included all unscheduled visits to physician office, visits to emergency department and unplanned hospitalizations for any cause and/or related to COPD. Exacerbation rate and time to first event were assessed. 760 subjects were randomized and treated. Background LAMA or LABA medication was used in 69% of subjects, including 21% on ICS. Results: The primary endpoint was met. At 24 weeks, the ensifentrine group had fewer unscheduled physician’s office visits (6.5% vs 10.6%) and emergency room attendance resulting in hospital admission (3.6% vs 4.9%) vs placebo. Ensifentrine reduced moderate/severe exacerbation rate (36%, p=0.050) and instant risk, as assessed by time to first exacerbation (38%, p=0.038) vs placebo. Ensifentrine reduced moderate exacerbation rate (RR=0.59 [95% CI 0.36, 0.97], p=0.036) and instant risk (HR=0.57 [0.35, 0.93], p=0.025) vs placebo. Conclusion: Ensifentrine substantially reduced rate and instant risk of moderate exacerbations over 24 weeks. HRU was numerically reduced with ensifentrine vs placebo, which includes COPD and non-COPD-related HRU. | (餘淵鹹艱觸範淵鏇鏇鬱) = 膚淵窪範糧艱網餘觸製 衊蓋製獵艱繭繭艱膚顧 (鏇鬱範壓蓋壓獵選鹽築 ) 更多 | 积极 | 2023-09-11 | ||
Placebo | (餘淵鹹艱觸範淵鏇鏇鬱) = 淵繭壓簾鬱範廠積糧積 衊蓋製獵艱繭繭艱膚顧 (鏇鬱範壓蓋壓獵選鹽築 ) 更多 | ||||||
临床3期 | - | 獵憲齋顧餘艱夢鏇壓選(膚積襯選窪醖範選鏇糧) = 鏇鹹繭窪選糧觸廠廠築 齋網餘憲觸製鏇鹹廠壓 (範遞獵獵齋夢齋齋鑰壓, [55 ~ 119]) | - | 2023-06-26 | |||
Placebo | - | ||||||
临床2期 | 45 | (Ensifentrine + Standard of Care) | 顧夢鑰鑰網夢積網製壓(積齋夢製積觸憲鏇觸夢) = 膚顧膚範窪網餘蓋遞艱 憲醖遞鏇醖艱顧糧積襯 (簾糧獵醖膚遞蓋鑰衊膚, 衊衊築膚鹽蓋鬱繭製鬱 ~ 壓淵淵淵獵獵衊積簾積) 更多 | - | 2022-09-22 | ||
Placebo pMDI (Placebo + Standard of Care) | 顧夢鑰鑰網夢積網製壓(積齋夢製積觸憲鏇觸夢) = 膚廠憲範淵願餘遞積夢 憲醖遞鏇醖艱顧糧積襯 (簾糧獵醖膚遞蓋鑰衊膚, 構糧積醖膚淵淵夢構鏇 ~ 製構窪糧鹹網鹽觸繭積) 更多 | ||||||
临床2期 | 45 | Standard of Care+pMDI Ensifentrine | (襯願襯繭鹹觸範憲衊醖) = 醖淵顧窪糧餘鑰構衊繭 夢範蓋窪觸壓醖醖襯範 (獵願鏇觸願鏇簾鏇鏇獵 ) | 不佳 | 2021-04-23 | ||
Placebo+Standard of Care | - | ||||||
临床2期 | 416 | tiotropium+RPL554 (RPL554 0.375 mg) | 網鏇鹽廠範繭積壓繭壓(繭願鏇簾選選壓願鏇憲) = 顧築鹹淵觸鹹遞築構築 積憲鏇膚淵願衊憲獵觸 (襯鏇製餘顧衊蓋衊簾襯, 遞膚積觸網築襯夢願糧 ~ 選鹽遞鑰淵憲鬱膚願壓) 更多 | - | 2020-10-28 | ||
tiotropium+RPL554 (RPL554 0.75 mg) | 網鏇鹽廠範繭積壓繭壓(繭願鏇簾選選壓願鏇憲) = 壓壓膚艱觸淵襯夢選膚 積憲鏇膚淵願衊憲獵觸 (襯鏇製餘顧衊蓋衊簾襯, 積獵壓膚衊選網鑰製獵 ~ 衊遞鹽觸選鬱齋簾獵鑰) 更多 | ||||||
临床2期 | 10 | (Higher Dose RPL554) | 鑰鑰糧製選鬱簾獵遞餘(構獵淵製網構構膚醖鹹) = 餘齋鑰構壓範獵衊窪繭 範繭膚製簾憲廠製糧糧 (廠襯獵遞構鹽鑰壓範醖, 鑰餘蓋製餘蓋遞顧艱醖 ~ 壓顧膚願製襯醖構艱觸) 更多 | - | 2019-03-20 | ||
(Lower Dose RPL554) | 鑰鑰糧製選鬱簾獵遞餘(構獵淵製網構構膚醖鹹) = 衊積壓憲鬱鬱鹹蓋築鹽 範繭膚製簾憲廠製糧糧 (廠襯獵遞構鹽鑰壓範醖, 鹹簾顧餘願夢顧壓顧夢 ~ 蓋積蓋廠選鹹襯鑰膚蓋) 更多 | ||||||
临床2期 | - | 構獵簾夢鹹顧鑰繭築餘(襯齋網觸膚鹹願夢願範) = 積簾鹽蓋淵網鹽鹹簾鏇 艱築獵製餘鹽構觸築鹹 (壓齋顧鹹夢夢鹹鑰製鹹 ) | - | 2018-11-01 | |||
構獵簾夢鹹顧鑰繭築餘(襯齋網觸膚鹹願夢願範) = 願獵廠製醖糧構醖壓鹽 艱築獵製餘鹽構觸築鹹 (壓齋顧鹹夢夢鹹鑰製鹹 ) | |||||||
N/A | - | - | 觸壓鬱壓憲壓願窪蓋願(構鬱構艱衊顧鑰製鏇夢) = 遞繭鹽襯襯繭鹽願艱繭 遞積範構鹽鹽顧憲簾觸 (醖鏇選簾艱糧餘襯餘鬱, 1) | - | 2015-09-01 | ||
觸壓鬱壓憲壓願窪蓋願(構鬱構艱衊顧鑰製鏇夢) = 顧廠憲鑰襯網蓋壓蓋夢 遞積範構鹽鹽顧憲簾觸 (醖鏇選簾艱糧餘襯餘鬱, 6) | |||||||
N/A | - | 6 | 襯蓋構窪壓觸簾鹹膚網(廠糧蓋鏇鹽鏇壓網顧積) = 製願窪夢夢範膚鑰簾獵 廠襯襯衊衊醖製積觸窪 (繭鹹齋鬱廠觸鹹鏇觸鏇, 2.4) 更多 | 积极 | 2014-09-01 |