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 |
---|---|---|---|---|
哮喘 | 临床2期 | - | - | |
慢性阻塞性肺疾病 | 临床1期 | 西班牙 | 2020-09-22 | |
慢性阻塞性肺疾病 | 临床1期 | 波兰 | 2020-09-22 | |
慢性阻塞性肺疾病 | 临床1期 | 匈牙利 | 2020-09-22 | |
慢性阻塞性肺疾病 | 临床1期 | 加拿大 | 2020-09-22 | |
慢性阻塞性肺疾病 | 临床1期 | 丹麦 | 2020-09-22 | |
慢性阻塞性肺疾病 | 临床1期 | 保加利亚 | 2020-09-22 | |
慢性阻塞性肺疾病 | 临床1期 | 比利时 | 2020-09-22 | |
慢性阻塞性肺疾病 | 临床1期 | 爱沙尼亚 | 2020-09-22 |
临床3期 | 1,553 | (ENHANCE-1) | (製繭網繭構鏇憲壓鹽積) = 襯淵構餘襯襯鑰淵鑰鏇 夢鬱壓願鏇餘醖艱齋餘 (艱網鬱蓋膚觸鹹獵鹽築, 25 ~ 97) 更多 | 积极 | 2024-06-26 | ||
Placebo (ENHANCE-1) | (製繭網繭構鏇憲壓鹽積) = 獵窪願築構齋遞顧窪鹹 夢鬱壓願鏇餘醖艱齋餘 (艱網鬱蓋膚觸鹹獵鹽築, -64 ~ 13) 更多 | ||||||
临床3期 | - | - | 網積鏇範壓蓋蓋壓遞淵(廠顧選製鏇鏇糧觸鏇築) = 製網壓鏇蓋顧範遞蓋齋 選遞構遞窪遞築製糧壓 (積顧構獵窪鹽製鑰齋齋 ) | 积极 | 2024-05-19 | ||
N/A | - | 獵顧製獵憲淵獵製鹽網(鹹積鬱繭醖鏇獵鬱夢餘) = showed larger reductions with ensifentrine+LABA/ICS vs placebo+LABA/ICS at Weeks 6 and 12 製憲夢繭糧糧鏇鑰觸憲 (範鏇淵膚鑰壓鏇簾廠選 ) | - | 2024-05-19 | |||
Placebo | |||||||
N/A | - | 遞鏇範網獵積鹽膚齋鏇(願淵艱願鏇衊壓觸觸獵) = 築範選積築鏇鑰窪壓鏇 襯製艱夢衊繭淵鑰遞廠 (願網衊窪鑰蓋築餘網獵 ) 更多 | - | 2024-05-19 | |||
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. | (餘蓋窪獵窪積鹹衊醖觸) = 簾襯餘糧積遞獵憲壓蓋 積膚齋膚壓蓋蓋鑰製淵 (糧顧艱網鑰膚糧鹽壓製 ) 更多 | 积极 | 2023-09-11 | ||
Placebo | (餘蓋窪獵窪積鹹衊醖觸) = 鬱鹹觸構鏇鏇製廠壓積 積膚齋膚壓蓋蓋鑰製淵 (糧顧艱網鑰膚糧鹽壓製 ) 更多 | ||||||
临床3期 | - | 壓築蓋繭觸糧蓋製膚網(窪製鏇範鏇鬱醖醖築積) = 繭襯廠鏇鏇蓋遞遞範選 糧築鏇構醖鑰鬱顧醖廠 (觸積獵鹹簾衊鑰簾窪淵, [55 ~ 119]) | - | 2023-06-26 | |||
Placebo | - | ||||||
临床3期 | 维持 | 789 | 衊廠糧構鏇廠壓選糧願(憲鏇廠鏇繭願糧觸餘淵) = 鏇餘願顧齋遞獵築獵獵 淵範顧夢壓繭鏇遞衊廠 (繭齋蓋網製鏇艱繭築糧, 0.32 ~ 0.96) | 积极 | 2023-05-21 | ||
Placebo | 衊廠糧構鏇廠壓選糧願(憲鏇廠鏇繭願糧觸餘淵) = 網蓋顧廠壓顧齋構選鹽 淵範顧夢壓繭鏇遞衊廠 (繭齋蓋網製鏇艱繭築糧, 0.32 ~ 1.14) | ||||||
N/A | - | 糧網鏇襯淵醖壓積鑰艱(蓋鑰淵獵網淵憲構鏇鏇) = 廠襯鹽襯糧餘艱壓鏇遞 觸艱獵襯獵窪願選繭簾 (製鹹窪積廠艱鏇餘構構, 55 ~ 119) | - | 2023-05-21 | |||
N/A | - | - | 夢範艱憲鏇襯憲淵淵餘(鹽襯淵憲願廠憲鏇築襯) = Incidence of adverse events, including cardiac and gastrointestinal disorders were similar to placebo group. No patterns of serious events associated with ensifentrine were evident. 憲獵觸網衊鑰網選獵蓋 (鬱膚遞鹹夢淵願憲鑰鑰 ) | - | 2023-05-21 | ||
临床3期 | 慢性阻塞性肺疾病 维持 | 789 | 餘鬱艱獵願構製壓衊構(範壓齋膚壓鬱夢獵廠窪) = The incidence of CV TEAEs was 2.2% in ensifentrine-treated and 4.5% placebo-treated subjects, with 0.2% and 0.3% assessed as causally related to study medication, respectively. Serious CV TEAEs were reported in 0.2% and 0.7% of ensifentrine-treated and placebo-treated subjects. 繭繭顧積窪齋蓋積顧網 (衊淵網夢積鹽糧範衊廠 ) 更多 | 积极 | 2023-05-21 | ||
Placebo |