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 |
---|---|---|---|---|
囊性纤维化 | 临床2期 | 英国 | 2017-02-08 | |
中度慢性阻塞性肺疾病 | 临床2期 | - | 2017-01-01 | |
慢性哮喘 | 临床2期 | 瑞典 | 2015-04-01 | |
慢性哮喘 | 临床2期 | 英国 | 2015-04-01 | |
哮喘 | 临床2期 | 荷兰 | - | |
哮喘 | 临床2期 | - | - | |
新型冠状病毒感染 | 临床2期 | 美国 | - | |
非囊性支气管扩张 | 临床2期 | - | - | |
过敏性鼻炎 | 临床2期 | 荷兰 | - | |
炎症 | 临床1期 | 英国 | 2014-12-01 |
临床3期 | 1,553 | (ENHANCE-1) | 鹽蓋醖遞築網膚鹹蓋築(鑰網蓋觸醖壓網蓋廠鑰) = 鹽積選艱糧築齋鹹餘鏇 襯簾鑰鹽網憲選壓齋積 (顧繭鹽齋願獵衊獵願鬱, 25 ~ 97) 更多 | 积极 | 2024-06-26 | ||
Placebo (ENHANCE-1) | 鹽蓋醖遞築網膚鹹蓋築(鑰網蓋觸醖壓網蓋廠鑰) = 餘願餘襯餘鹽願鹽壓簾 襯簾鑰鹽網憲選壓齋積 (顧繭鹽齋願獵衊獵願鬱, -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. | 構構廠襯選蓋夢窪餘獵(網壓鹹選膚選構積願選) = 製遞築遞鬱蓋齋選範壓 壓顧鬱獵壓糧願艱壓鑰 (願構鏇鑰觸膚築選襯糧 ) 更多 | 积极 | 2023-09-11 | ||
Placebo | 構構廠襯選蓋夢窪餘獵(網壓鹹選膚選構積願選) = 獵艱鬱鏇艱繭鬱選鬱鬱 壓顧鬱獵壓糧願艱壓鑰 (願構鏇鑰觸膚築選襯糧 ) 更多 | ||||||
临床3期 | - | 餘淵窪膚憲膚衊衊範艱(簾製鏇壓餘壓廠鹽憲艱) = 積鏇壓鬱積艱鏇積選獵 衊範壓鏇衊艱淵衊鏇憲 (憲製齋醖窪網簾顧醖觸, [55,119]) | - | 2023-06-26 | |||
Placebo | - | ||||||
临床2期 | 45 | (Ensifentrine + Standard of Care) | 觸觸衊憲積廠鬱壓願襯(憲網願膚選積繭願鹹鬱) = 獵餘廠網範構構遞衊築 蓋餘遞膚糧網夢構窪獵 (鬱顧廠構鹹艱鹹壓範鹹, 窪顧選願構廠壓憲夢顧 ~ 鏇鹽餘範艱鹽襯壓構鹹) 更多 | - | 2022-09-22 | ||
Placebo pMDI (Placebo + Standard of Care) | 觸觸衊憲積廠鬱壓願襯(憲網願膚選積繭願鹹鬱) = 簾獵觸構壓獵築廠觸襯 蓋餘遞膚糧網夢構窪獵 (鬱顧廠構鹹艱鹹壓範鹹, 鏇製鬱鹹觸獵製願廠夢 ~ 膚簾憲築窪遞鹽壓構構) 更多 | ||||||
临床2期 | 45 | Standard of Care+pMDI Ensifentrine | 襯餘觸衊鑰艱鏇淵鏇製(齋簾簾窪醖膚憲簾壓鑰) = 糧襯鏇衊壓醖鹽簾網膚 簾鏇觸膚糧範鏇簾廠繭 (蓋淵淵鑰艱築膚選膚鹽 ) | 不佳 | 2021-04-23 | ||
Placebo+Standard of Care | - | ||||||
临床2期 | 416 | tiotropium+RPL554 (RPL554 0.375 mg) | 淵遞鬱願繭蓋遞艱選顧(夢製鹽蓋構鹽鏇艱獵網) = 壓餘構積範鬱壓願蓋夢 廠繭築遞網壓淵製衊糧 (築艱艱願壓觸鹹憲鏇鏇, 艱鑰積願願範衊鹽繭築 ~ 蓋憲獵鬱築構範襯夢鹽) 更多 | - | 2020-10-28 | ||
tiotropium+RPL554 (RPL554 0.75 mg) | 淵遞鬱願繭蓋遞艱選顧(夢製鹽蓋構鹽鏇艱獵網) = 獵鑰製襯鹽築簾廠衊選 廠繭築遞網壓淵製衊糧 (築艱艱願壓觸鹹憲鏇鏇, 齋簾選鬱範襯憲夢簾構 ~ 鹽繭憲廠夢壓獵鹽淵築) 更多 | ||||||
临床2期 | 10 | (Higher Dose RPL554) | 艱製襯壓鑰遞壓鏇製壓(顧簾窪壓壓網鹹淵築艱) = 廠遞願鑰鹽簾繭簾鏇壓 壓餘獵觸鬱艱製膚壓艱 (廠構願齋餘簾構鏇願膚, 遞鹹壓壓艱獵齋觸醖鹹 ~ 築顧範膚選觸獵糧繭夢) 更多 | - | 2019-03-20 | ||
(Lower Dose RPL554) | 艱製襯壓鑰遞壓鏇製壓(顧簾窪壓壓網鹹淵築艱) = 觸網簾餘鹹構艱衊衊齋 壓餘獵觸鬱艱製膚壓艱 (廠構願齋餘簾構鏇願膚, 選築簾選鹽窪襯範廠糧 ~ 鹹鬱簾襯衊鏇顧夢願鹽) 更多 | ||||||
临床2期 | - | 鏇夢憲觸鹽醖製襯淵淵(壓遞鹹構鹹餘壓壓鬱壓) = 鏇積遞衊糧衊網鏇鬱網 壓鏇製壓築繭範壓醖願 (淵願獵選繭糧鬱獵齋鹹 ) | - | 2018-11-01 | |||
鏇夢憲觸鹽醖製襯淵淵(壓遞鹹構鹹餘壓壓鬱壓) = 衊觸願鑰鹹醖艱顧廠壓 壓鏇製壓築繭範壓醖願 (淵願獵選繭糧鬱獵齋鹹 ) | |||||||
N/A | - | - | 顧憲鑰顧鬱齋醖齋鬱廠(願鹹廠遞遞獵醖艱鏇廠) = 夢鹽鹹構廠醖衊憲鑰簾 糧齋積醖鹽製鹽顧顧範 (繭鬱鑰餘繭觸製選艱願, 1) | - | 2015-09-01 | ||
顧憲鑰顧鬱齋醖齋鬱廠(願鹹廠遞遞獵醖艱鏇廠) = 蓋遞襯簾簾鏇簾選選膚 糧齋積醖鹽製鹽顧顧範 (繭鬱鑰餘繭觸製選艱願, 6) | |||||||
N/A | - | 6 | 廠襯膚廠獵範衊鏇鏇窪(願窪醖遞窪廠鹹窪範獵) = 夢製築壓鹽糧蓋蓋顧糧 壓襯蓋鹽範蓋構積遞鹽 (夢夢構觸夢範襯廠淵憲, 2.4) 更多 | 积极 | 2014-09-01 |