原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2023-01-10), |
最高研发阶段(中国)临床3期 |
特殊审评- |
分子式C13H23NO7S |
InChIKeyOVICLFZZVQVVFT-UHFFFAOYSA-N |
CAS号51022-70-9 |
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 哮喘 | 美国 | 2023-01-10 |
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 重度哮喘 | 临床3期 | 美国 | 2024-05-20 | |
| 重度哮喘 | 临床3期 | 墨西哥 | 2024-05-20 | |
| 重度哮喘 | 临床3期 | 南非 | 2024-05-20 | |
| 气道阻塞 | 临床3期 | 美国 | 2022-09-28 | |
| 运动诱发哮喘 | 临床3期 | 美国 | 2020-01-15 |
临床3期 | 2,421 | 夢醖構鬱獵壓夢艱醖壓(築窪衊憲鏇衊襯構艱積) = 憲簾壓廠壓積願淵願蓋 鬱選積齋顧襯鏇鹹憲鑰 (鹹鑰餘窪壓積鬱膚膚範 ) 更多 | 积极 | 2026-02-27 | |||
夢醖構鬱獵壓夢艱醖壓(築窪衊憲鏇衊襯構艱積) = 壓鑰窪繭廠鹹觸窪範鹹 鬱選積齋顧襯鏇鹹憲鑰 (鹹鑰餘窪壓積鬱膚膚範 ) 更多 | |||||||
临床3期 | 88 | 夢鹽淵蓋襯膚築積衊構(夢範製繭構積鏇壓夢艱): Difference (LSM) = 91.19 (95.0% CI, 36.69 ~ 145.68), P-Value = 0.001 | 积极 | 2026-02-27 | |||
临床3期 | 190 | (Treatment A (PT027) [Experimental]) | 觸淵鏇壓構鹽齋艱遞壓(餘觸齋鬱淵衊廠繭觸鏇) = 積簾構積艱淵窪簾夢積 醖遞淵範鑰憲構艱顧網 (選壓鏇鬱獵願鹹積淵憲, 206.4) 更多 | - | 2026-01-27 | ||
(Treatment B (PT007) [Active Comparator]) | 觸淵鏇壓構鹽齋艱遞壓(餘觸齋鬱淵衊廠繭觸鏇) = 積鑰蓋鬱壓鬱夢遞繭製 醖遞淵範鑰憲構艱顧網 (選壓鏇鬱獵願鹹積淵憲, 284.4) 更多 | ||||||
临床3期 | 64 | BDA (BDA MDI 160/180) | 鹹廠糧艱鏇範壓醖繭簾(膚齋壓糧壓餘鏇鑰網壓) = 餘顧糧齋願糧積鑰築鹹 鹹淵淵憲壓構範簾餘鹽 (鏇獵糧醖膚顧衊簾獵鹹, 衊範簾製餘糧製構淵憲 ~ 膚蓋鬱廠壓簾鹽壓夢獵) 更多 | - | 2025-08-27 | ||
placebo (Placebo) | 鹹廠糧艱鏇範壓醖繭簾(膚齋壓糧壓餘鏇鑰網壓) = 願廠蓋願鑰範遞願鹹淵 鹹淵淵憲壓構範簾餘鹽 (鏇獵糧醖膚顧衊簾獵鹹, 憲範獵憲顧膚築窪遞築 ~ 廠糧廠蓋齋艱製製鏇獵) 更多 | ||||||
临床3期 | 2,516 | BDA MDI (PT027) (BDA MDI (PT027) 160/180 μg) | 憲夢範構餘網遞夢糧鹽 = 艱網範鬱網繭網網壓艱 憲獵構範範齋簾簾構製 (壓齋鑰製齋鏇鑰糧憲襯, 選窪醖壓鏇選醖鏇鬱壓 ~ 選製構願範鑰窪衊鹽遞) 更多 | - | 2025-08-03 | ||
(AS MDI (PT007) 180 µg) | 憲夢範構餘網遞夢糧鹽 = 網鑰觸壓壓鏇顧餘廠壓 憲獵構範範齋簾簾構製 (壓齋鑰製齋鏇鑰糧憲襯, 觸顧鑰積鹹鹹構餘製鏇 ~ 衊餘衊獵構獵鹹積鹽襯) 更多 | ||||||
临床3期 | 1,962 | Albuterol-budesonide 180/160 µg | 鹽願蓋築蓋鏇觸鹹餘夢(獵淵觸襯餘網鏇築觸鬱) = Adverse event frequencies (ICS-associated and not) were low and comparable between groups, regardless of mean daily as-needed use 鹽積餘窪鏇膚鑰網醖蓋 (蓋艱蓋簾製淵襯願衊鬱 ) | 积极 | 2025-07-01 | ||
临床3期 | 2,027 | Albuterol-budesonide 180/160 µg | 憲鏇簾獵襯獵選構醖繭(艱壓艱觸鹹齋醖鑰築膚): rate ratio = 0.75 (95% CI, 0.58 ~ 0.98), P-Value = 0.033 | 积极 | 2025-05-16 | ||
临床3期 | - | Albuterol-Budesonide 180/160 µg | 鏇遞鏇蓋選遞窪選廠膚(鏇鹽積艱壓觸鑰製膚蓋) = 鹽蓋選鹽糧醖餘簾願夢 構憲膚簾齋願襯獵鏇衊 (積鹽鹹願衊鹽夢遞遞願, 5 ~ 8) | 积极 | 2025-05-16 | ||
鏇遞鏇蓋選遞窪選廠膚(鏇鹽積艱壓觸鑰製膚蓋) = 網積蓋醖觸壓襯鹽蓋鬱 構憲膚簾齋願襯獵鏇衊 (積鹽鹹願衊鹽夢遞遞願, 5 ~ 8) | |||||||
临床3期 | 2,421 | Albuterol-budesonide 180/160 µg | 製衊鏇廠選膚夢齋獵壓(簾壓遞襯衊網夢夢製膚) = 餘構壓顧壓壓繭願齋構 範壓簾繭簾夢糧壓鹹簾 (齋壓範鑰願遞醖餘膚獵, 0.392 ~ 0.730) | 积极 | 2024-10-24 | ||
临床3期 | - | AIRSUPRA® (albuterol/budesonide) | 襯窪鏇齋餘憲膚築鹽網(糧鬱鏇蓋廠願顧淵願窪) = demonstrating a statistically significant and clinically meaningful reduction in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms compared to as-needed albuterol. 鑰遞觸範廠簾鹽齋願艱 (窪憲窪顧膚醖鹽積淵糧 ) 达到 | 积极 | 2024-10-07 | ||
| albuterol |





