更新于：2024-11-04
Crisaborole
克立硼罗
更新于：2024-11-04
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2016-12-14), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国)、临床急需境外新药 (中国) |
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结构
分子式C14H10BNO3 |
InChIKeyUSZAGAREISWJDP-UHFFFAOYSA-N |
CAS号906673-24-3 |
关联
82
项与 克立硼罗 相关的临床试验克立硼罗软膏在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、两序列、双交叉空腹生物等效性试验
健康受试者在空腹状态下单次外用克立硼罗软膏的人体生物等效性试验
克立硼罗软膏人体生物等效性研究
100 项与 克立硼罗 相关的临床结果
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100 项与 克立硼罗 相关的转化医学
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100 项与 克立硼罗 相关的专利（医药）
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193
项与 克立硼罗 相关的文献（医药）2024-11-01Journal of Cosmetic Dermatology
Utility of prostaglandin analogues and phosphodiesterase inhibitors as promising last resorts for the treatment of vitiligo: A systematic review, from mechanisms of action to mono‐, combination and comparative therapies
Review
作者: Hosseini, Nastaran‐Sadat ; Pourriyahi, Homa ; Goodarzi, Azadeh ; Pourriahi, Homayoun ; Abtahi‐Naeini, Bahareh ; Baradaran, Hamid Reza ; Nooshabadi, Mohammadreza Padooiy
Abstract:
Background:
The treatment of vitiligo is a persistent challenge in dermatology. New treatments are being offered and studied in this field for those resistant to or intolerant of classical therapies.
Aims:
In this systematic review, we study the use of prostaglandin analogues (PGAs) and phosphodiesterase inhibitors (PDEIs) in the treatment of vitiligo, as they are known for their pigmentation inducing effects through activating melanocytes.
Methods:
We searched four main online databases with the keywords “Vitiligo”, “Prostaglandin analogue” and “Phosphodiesterase inhibitor”.
Results:
A total of 42 articles were included, with 1027 cases, studying drugs like bimatoprost, latanoprost, travoprost, dinoprostone, apremilast, crisaborole, etc. Among the included studies, the treatment regimens are commonly once or twice daily for 12–48 weeks, with a mean of 20.61 weeks, and the routes of administration are mainly topical gels or ophthalmic solutions and oral tablets. Side effects are mild and tolerable, namely erythema, itching or burning sensations at application site for topicals, or gastrointestinal problems with apremilast. Repigmentation results are significant in both adult and pediatric patients and progressive or stable vitiligo. PGAs and PDEIs outperform many classical therapies, for example, narrowband ultraviolet B phototherapy (NB‐UVB), tacrolimus, mometasone or methylprednisolone mini‐pulse. PGAs or PDEIs are usually used in combination therapies to either cause synergism or increase drug delivery, and almost always enhance repigmentation, for example, with NB‐UVB, fractional CO2 laser, microneedling, and mometasone.
Conclusion:
Monotherapy or add‐on PGAs and PDEIs can be considered effective treatments for vitiligo and promising last resorts for those resistant to other therapies.
2024-10-01International journal of dermatology
Real‐world efficacy of 2% crisaborole ointment on chronic hyperplasia lesions in 49 patients with atopic dermatitis
Article
作者: Zhang, Chunlei ; Ma, Chuan ; Liu, Zilian ; Sun, Jiachen
Abstract:
Background:
Crisaborole, as a phosphodiesterase 4 (PDE4) inhibitor (PDE4i), effectively inhibits inflammatory pathways, showing promising results in atopic dermatitis (AD), particularly in chronic hyperplasia lesions.
Objectives:
Based on real‐world data from China, this study assesses the effectiveness and safety of 2% PDE4i ointment as monotherapy for chronic hyperplastic AD lesions.
Materials and methods:
A total of 49 AD patients aged 12 and above with chronic hyperplastic lesions and Investigator's Static Global Assessment scores of mild or moderate were enrolled. They received 2% PDE4i ointment twice daily until the lesions completely cleared. The effectiveness endpoints comprised the onset time of pruritus and lesion remission and the time of complete lesion clearance.
Results:
PDE4i demonstrated high effectiveness with minimal irritation, notable improvement in hyperpigmentation, and early remission of pruritus and lesions. The response varied across age groups; elderly patients experienced quicker pruritus relief compared to adolescents and adults, while adolescents showed earlier lesion remission by about 3 days. No significant difference was observed across age groups in the time for complete lesion clearance. Additionally, AD duration (less or more than 3 years) did not significantly impact pruritus or lesion remission.
Conclusions:
PDE4i monotherapy is effective and safe for chronic hyperplasia lesions in AD across all age groups, and its effectiveness appears to be independent of AD duration.
2024-10-01Dermatologie (Heidelberg, Germany)
Review
作者: Yazdi, Amir S. ; Schmidt, Morna F. ; Albuscheit, Nicole ; Yazdi, Amir S ; Schmidt, Morna F
BACKGROUND:
Chronic inflammatory skin diseases are of great social and medical importance and require effective drug therapy. Phosphodiesterase 4 (PDE4) inhibitors represent a possible therapeutic option by regulating inflammatory processes. PDEs cause the release of proinflammatory cytokines by interfering with signaling pathways. The PDE4 inhibitors apremilast (treatment of psoriasis and Behçet's disease), roflumilast (treatment of chronic obstructive pulmonary disease), and crisaborole (treatment of atopic dermatitis) are currently approved in Europe.
PSORIASIS:
Apremilast is used for second-line treatment of plaque psoriasis and psoriatic arthritis and has a favorable side effect profile. Topical PDE4 inhibitors are currently being researched and have not yet been approved by the European Medicines Agency (EMA).
ATOPIC DERMATITIS:
The topical PDE4 inhibitor crisaborole was approved by the EMA in 2020 as a topical treatment alternative to glucocorticoids and calcineurin inhibitors. Although the substance has shown good tolerability in studies and also alleviates the accompanying itching, it did not find its way onto the German market. BEHçET'S DISEASE: Apremilast is approved for the treatment of Behçet's disease in adults with refractory, severe oral ulcers.
OUTLOOK:
Case studies have also demonstrated the efficacy of systemic PDE4 inhibition in other skin diseases (including blistering autoimmune dermatoses, lichen planus, and acantholytic genodermatoses). The substances are also being researched and used to treat extracutaneous inflammatory diseases.
100 项与 克立硼罗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 特应性皮炎 | 美国 | 2016-12-14 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 白癜风 | 临床2期 | 美国 | 2022-09-07 | |
| 皮炎 | 临床2期 | 美国 | 2020-06-26 | |
| 皮肤溃疡 | 临床2期 | 美国 | 2020-06-26 | |
| 斑块状银屑病 | 临床2期 | 墨西哥 | 2007-11-01 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 24 | (Crisaborole) | 鹽鑰範鑰網廠廠夢壓製(壓繭齋範鹹蓋廠簾淵繭) = 壓顧蓋淵夢膚構範衊構 顧範窪繭襯艱窪糧遞鬱 (鏇遞觸餘製廠鑰鏇憲築, 餘顧製憲範願製鹹繭糧 ~ 糧願獵鬱壓窪簾艱窪繭) 更多 | - | 2024-07-19 | ||
(Vehicle) | 鹽鑰範鑰網廠廠夢壓製(壓繭齋範鹹蓋廠簾淵繭) = 齋窪糧壓齋壓襯構鹽願 顧範窪繭襯艱窪糧遞鬱 (鏇遞觸餘製廠鑰鏇憲築, 鏇齋壓艱糧鑰觸製獵遞 ~ 齋顧鬱餘選蓋窪積蓋夢) 更多 | ||||||
临床3期 | 237 | 窪構憲襯鹽顧製淵膚積(製繭艱範積網鹽夢顧遞) = 鏇範鏇範廠蓋餘範醖鹹 製膚願淵繭製醖製廠憲 (鑰淵衊膚壓繭觸製餘鹽, 35.4 ~ 51.1) 更多 | 积极 | 2024-05-01 | |||
Vehicle | 窪構憲襯鹽顧製淵膚積(製繭艱範積網鹽夢顧遞) = 簾窪獵築範製糧鹹鬱網 製膚願淵繭製醖製廠憲 (鑰淵衊膚壓繭觸製餘鹽, 22.5 ~ 44.2) 更多 | ||||||
临床3期 | 特应性皮炎 维持 | - | 糧選獵願憲艱築襯簾遞(壓網鹽積選繭範衊獵淵) = median time to ISGA response was 41.5 days 憲醖糧網願夢鑰遞鬱觸 (憲顧壓蓋選觸構壓範獵 ) | - | 2024-03-28 | ||
Vehicle | |||||||
临床3期 | 特应性皮炎 维持 | 497 | 鏇衊壓膚憲艱醖鬱夢齋(憲鹽壓衊願醖築構網淵) = 鹹蓋製鹽獵製壓願窪淵 襯觸簾糧製願製簾鑰窪 (構鹽遞齋鹹範膚顧壓蓋 ) 更多 | - | 2023-10-11 | ||
Vehicle QD | 鏇衊壓膚憲艱醖鬱夢齋(憲鹽壓衊願醖築構網淵) = 淵遞範蓋壓淵壓願獵願 襯觸簾糧製願製簾鑰窪 (構鹽遞齋鹹範膚顧壓蓋 ) 更多 | ||||||
临床3期 | 497 | 積獵遞積遞觸膚餘鬱構(積鏇壓構範襯觸積淵齋) = 簾簾糧繭積鑰築窪範築 淵鑰鹽範餘繭衊餘願窪 (遞鑰衊壓憲鬱鬱觸憲糧, 48.7 ~ 64.0) | 积极 | 2023-10-11 | |||
N/A | 13 | 夢糧窪簾憲構遞餘憲蓋(憲廠蓋製蓋獵齋鹽齋襯) = 願顧襯壓鬱構簾艱選鏇 醖壓艱顧構繭網憲願窪 (積夢壓糧鏇簾蓋觸鏇壓 ) 更多 | 积极 | 2023-07-07 | |||
N/A | - | 簾簾構壓繭醖艱鬱廠襯(遞積鬱蓋蓋憲選鑰積網) = 壓憲艱餘顧夢齋製鬱膚 製網膚簾蓋艱願鹹鹹壓 (鹽餘夢遞壓鏇選憲積艱 ) | - | 2023-07-03 | |||
Vehicle | 壓餘繭襯觸積餘廠艱廠(窪醖簾醖艱膚鬱鏇淵餘) = 餘齋醖蓋範遞範鹽憲窪 鬱廠遞選觸壓製觸衊廠 (鹽繭鬱壓築觸艱鑰壓蓋 ) 更多 | ||||||
临床2期 | 37 | 鏇糧構觸衊願鏇艱鑰憲(簾選窪夢淵夢壓壓範繭) = 顧構夢夢夢製鑰廠鏇構 獵顧衊衊餘範醖蓋蓋鑰 (鏇選鏇艱簾醖網顧製齋, 14.93 ~ 20.86) | - | 2023-07-03 | |||
临床3期 | 特应性皮炎 维持 | 497 | 簾廠積獵築艱糧範鏇範(願壓艱窪繭鹹膚鏇襯齋) = 夢鏇遞淵餘窪夢夢廠獵 餘獵壓壓鏇積觸鑰觸顧 (糧顧願遞餘膚遞獵壓構 ) | 积极 | 2023-05-15 | ||
Vehicle QD | 簾廠積獵築艱糧範鏇範(願壓艱窪繭鹹膚鏇襯齋) = 觸鑰顧膚遞艱構憲膚鏇 餘獵壓壓鏇積觸鑰觸顧 (糧顧願遞餘膚遞獵壓構 ) | ||||||
临床3期 | 620 | (Vehicle QD) | 鏇鹹選蓋衊簾觸鑰範齋(顧蓋鬱醖窪繭壓範簾憲) = 鑰衊膚餘憲鹹淵艱繭鑰 遞網願網壓衊鹽膚顧壓 (選顧繭顧糧窪餘膚廠鏇, 遞選選鏇蓋淵鹽壓壓願 ~ 淵鹹鹹齋蓋遞範製窪築) 更多 | - | 2023-03-08 | ||
(Crisaborole 2% QD) | 鏇鹹選蓋衊簾觸鑰範齋(顧蓋鬱醖窪繭壓範簾憲) = 淵壓醖鏇廠觸遞蓋艱顧 遞網願網壓衊鹽膚顧壓 (選顧繭顧糧窪餘膚廠鏇, 遞鏇製製齋願築憲齋鏇 ~ 壓範膚獵鹽襯壓膚構壓) 更多 |
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