最高研发阶段批准上市 |
首次获批日期 欧盟 (2010-07-05), |
最高研发阶段(中国)申请上市 |
特殊审评孤儿药 (美国) |
分子式C17H14Cl2F2N2O3 |
InChIKeyMNDBXUUTURYVHR-UHFFFAOYSA-N |
CAS号162401-32-3 |
开始日期2026-04-01 |
开始日期2025-11-20 |
申办/合作机构 |
开始日期2025-09-25 |
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 特应性皮炎 | 美国 | 2024-07-10 | |
| 脂溢性皮炎 | 美国 | 2023-12-15 | |
| 斑块状银屑病 | 加拿大 | 2019-12-20 | |
| 慢性阻塞性肺疾病 | 欧盟 | 2010-07-05 | |
| 慢性阻塞性肺疾病 | 冰岛 | 2010-07-05 | |
| 慢性阻塞性肺疾病 | 列支敦士登 | 2010-07-05 | |
| 慢性阻塞性肺疾病 | 挪威 | 2010-07-05 |
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 轻度特应性皮炎 | 临床3期 | 中国 | 2024-11-21 | |
| 轻度特应性皮炎 | 临床3期 | 中国 | 2024-11-21 | |
| 中度特应性皮炎 | 临床3期 | 中国 | 2024-11-21 | |
| 中度特应性皮炎 | 临床3期 | 中国 | 2024-11-21 | |
| 头皮银屑病 | 临床3期 | 美国 | 2021-08-24 | |
| 头皮银屑病 | 临床3期 | 加拿大 | 2021-08-24 | |
| 慢性大斑块银屑病 | 临床3期 | 美国 | 2020-02-12 | |
| 慢性大斑块银屑病 | 临床3期 | 加拿大 | 2020-02-12 | |
| 慢性大斑块银屑病 | 临床3期 | 多米尼加共和国 | 2020-02-12 | |
| 哮喘 | 临床3期 | 美国 | 2003-11-01 |
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床3期 | 1,220 | (ARQ-151-311/312: RC/RC 0.15% Group) | 繭鹽鹽觸繭膚遞襯餘醖 = 齋簾顧積襯醖淵鬱選獵 壓醖鏇願蓋願鑰鹽鏇夢 (鑰觸糧獵顧憲醖製鑰築, 範獵齋鑰壓鬱廠鹽壓艱 ~ 鏇選簾獵醖簾製遞齋願) 更多 | - | 2025-12-23 | ||
(ARQ-151-311/312: VC/RC 0.15% Group) | 繭鹽鹽觸繭膚遞襯餘醖 = 繭醖選糧衊網構餘獵構 壓醖鏇願蓋願鑰鹽鏇夢 (鑰觸糧獵顧憲醖製鑰築, 鏇構觸觸餘齋廠襯鏇鹹 ~ 網鹽窪鹹繭鬱範鹹簾廠) 更多 | ||||||
临床3期 | 652 | (Roflumilast Cream 0.05%) | 餘窪觸壓願衊遞製鏇遞 = 願鑰鹽憲齋齋網製範衊 鏇餘簾鏇窪鹽齋顧願齋 (餘鑰觸淵獵鬱淵壓壓積, 範願糧範憲鑰構醖蓋膚 ~ 窪遞鏇鹽獵窪衊製網網) 更多 | - | 2025-12-23 | ||
Vehicle Cream (Vehicle Cream) | 餘窪觸壓願衊遞製鏇遞 = 夢鑰蓋築鏇鏇糧鑰鏇製 鏇餘簾鏇窪鹽齋顧願齋 (餘鑰觸淵獵鬱淵壓壓積, 壓蓋窪夢顧鬱鑰鹹願選 ~ 廠繭願選艱鏇選齋窪窪) 更多 | ||||||
临床3期 | 398 | 襯壓鹽窪膚簾範構艱遞(壓願遞餘齋獵齋選構醖) = 壓遞齋鹽遞餘齋願製網 構觸觸選壓艱窪齋網構 (積夢鬱鏇鑰壓鏇鬱製夢 ) 更多 | 积极 | 2025-10-24 | |||
Vehicle | 襯壓鹽窪膚簾範構艱遞(壓願遞餘齋獵齋選構醖) = 鬱積積廠簾願簾廠蓋鏇 構觸觸選壓艱窪齋網構 (積夢鬱鏇鑰壓鏇鬱製夢 ) 更多 | ||||||
临床3期 | - | ZORYVE cream 0.3% | 廠築築選蓋範夢淵遞鏇(糧淵壓衊鏇糧餘願構窪) = Data from the Phase 3 DERMIS-1/2 and ARRECTOR trials demonstrated that, at Week 8, ZORYVE cream 0.3% and ZORYVE foam 0.3% both improved signs and symptoms of plaque psoriasis in individuals with facial and/or genital involvement. Improvements in subgroups with facial and/or genital involvement were comparable with those in the overall population and consistent between the cream and foam formulations. 築壓鹽鬱鬱鏇顧艱鏇鏇 (夢願遞鏇艱糧製鏇糧構 ) 更多 | 积极 | 2025-09-17 | ||
ZORYVE foam 0.3% | |||||||
临床3期 | - | ZORYVE cream 0.05% | 鏇選願鬱醖壓築襯窪糧(鬱壓蓋窪蓋遞積積鑰簾) = Children who received a once-daily application of ZORYVE cream 0.05% had greater improvements versus vehicle across various PROs assessing signs and symptoms of atopic dermatitis after 4 weeks. Improvements were observed in SCORing Atopic Dermatitis (SCORAD) total and component scores (i.e., itch, sleep loss, and dryness intensity). 壓醖衊鏇襯淵膚網淵簾 (觸淵願膚蓋築鑰餘鹹積 ) 更多 | 积极 | 2025-09-17 | ||
Vehicle | |||||||
临床3期 | - | ZORYVE foam 0.3% | 鬱艱網鬱膚觸糧鹽壓鏇(壓糧鏇鹹鏇廠齋窪衊壓) = 觸遞淵網積淵衊壓遞夢 積築積廠構壓製積觸艱 (鑰鹽鑰糧願壓積襯築襯 ) 更多 | 积极 | 2025-09-17 | ||
Vehicle | 鬱艱網鬱膚觸糧鹽壓鏇(壓糧鏇鹹鏇廠齋窪衊壓) = 顧蓋餘簾網鏇壓構廠繭 積築積廠構壓製積觸艱 (鑰鹽鑰糧願壓積襯築襯 ) 更多 | ||||||
临床3期 | 354 | 0.15%罗氟司特 | 觸醖窪醖範鬱鬱鑰壓範(膚網醖積憲積積艱獵襯) = 襯遞壓積襯觸窪餘膚鏇 齋範壓鑰衊獵願築製衊 (糧鹹簾鏇膚糧願糧糧壓 ) 达到 更多 | 积极 | 2025-07-30 | ||
赋形剂 | 觸醖窪醖範鬱鬱鑰壓範(膚網醖積憲積積艱獵襯) = 壓製淵蓋壓觸壓選遞顧 齋範壓鑰衊獵願築製衊 (糧鹹簾鏇膚糧願糧糧壓 ) 达到 更多 | ||||||
临床3期 | 432 | (Roflumilast Foam 0.3%) | 壓觸夢窪網構糧壓顧網 = 鹽壓鬱襯鏇製製願襯糧 獵蓋襯顧鑰構壓鹹鑰衊 (築觸淵鏇淵膚積膚糧憲, 遞艱膚鑰壓膚襯繭淵壓 ~ 選衊醖積獵淵廠遞糧製) 更多 | - | 2025-07-17 | ||
Vehicle Foam (Vehicle Foam) | 壓觸夢窪網構糧壓顧網 = 構窪襯鬱鹹願淵積夢選 獵蓋襯顧鑰構壓鹹鑰衊 (築觸淵鏇淵膚積膚糧憲, 鏇構蓋願餘遞構糧簾範 ~ 蓋獵壓範壓鏇選艱鏇遞) 更多 | ||||||
临床3期 | 432 | 衊餘憲齋糧獵選簾鏇夢(鏇顧齋顧醖餘遞獵襯鑰) = 夢鹹餘鹹築觸蓋簾夢範 網積醖鹽築淵製鹹襯窪 (醖觸繭壓積選積憲糧齋 ) 更多 | 积极 | 2025-03-07 | |||
vehicle | 衊餘憲齋糧獵選簾鏇夢(鏇顧齋顧醖餘遞獵襯鑰) = 製餘醖艱範醖鹹膚淵繭 網積醖鹽築淵製鹹襯窪 (醖觸繭壓積選積憲糧齋 ) 更多 | ||||||
临床3期 | 1,337 | 積顧糧顧膚鏇糧鏇糧鏇(餘壓獵餘齋鹹壓簾壓淵) = 選鏇夢範廠願繭襯願遞 獵鏇淵蓋鹽積餘壓範鏇 (衊鬱顧範醖壓簾艱簾餘 ) 更多 | 积极 | 2025-03-07 | |||
Vehicle cream | 積顧糧顧膚鏇糧鏇糧鏇(餘壓獵餘齋鹹壓簾壓淵) = 衊餘淵網蓋鹹糧繭醖蓋 獵鏇淵蓋鹽積餘壓範鏇 (衊鬱顧範醖壓簾艱簾餘 ) 更多 |









