预约演示
更新于：2025-05-16
Crisaborole
克立硼罗
更新于：2025-05-16
概要
基本信息
权益机构- |
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/序列
分子式C14H10BNO3 |
InChIKeyUSZAGAREISWJDP-UHFFFAOYSA-N |
CAS号906673-24-3 |
关联
96
项与 克立硼罗 相关的临床试验CTR20251340
克立硼罗软膏空腹人体生物等效性研究
CTRI/2025/04/084122
Comparative efficacy of topical Crisaborole 2% ointment vs topical Tacrolimus 0.1% ointment in mild to moderate Atopic Dermatitis
CTRI/2025/03/083239
A comparative study evaluating the efficacy and safety of Crisaborole 2 percent ointment versus Betamethasone valerate 0.1 percent cream in Atopic dermatitis patients in a tertiary care hospital - NIL
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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287
项与 克立硼罗 相关的文献（医药）2025-05-01PEDIATRIC DRUGS
Efficacy and Safety of Proactive Therapy with 2% Crisaborole Ointment in Children with Mild-to-Moderate Atopic Dermatitis: A Randomized Controlled Study
Article
作者: Wang, Shan ; Shu, Hong ; Miao, Li-Min ; Meng, Yuan ; Cao, Rong ; Qian, Hua ; Luo, Xiao-Yan ; Yang, Huan ; Wang, Hua ; Li, Xiao-Li ; Li, Ping ; Chen, Jing-Ping ; Ma, Lin
BACKGROUND:
The effectiveness of crisaborole for proactive treatment of atopic dermatitis (AD) is not well established.
OBJECTIVES:
This study aims to investigate the efficacy and safety of a proactive treatment strategy with 2% crisaborole ointment for managing mild-to-moderate AD in children.
PATIENTS AND METHODS:
In this 16-week randomized-controlled trial, children aged 2-17 years with mild-to-moderate AD were enrolled. All participants received treatment with 0.1% mometasone furoate cream for 2 weeks. Those with an IGA score of ≤ 1 were randomly assigned in a 1:1 ratio to either the proactive treatment group, which received crisaborole combined with emollient twice daily, or the reactive treatment group, which received emollients alone, and in the event of disease relapse, both groups received 0.1% mometasone furoate cream as rescue treatment.
RESULTS:
Of the 153 patients screened, 142 were randomized; 73 to the proactive treatment group and 69 to the reactive treatment group. At the end of the 16-week trial, the proactive treatment group had a relapse rate of 43.84%, significantly lower than the 71.01% relapse rate in the reactive group (P = 0.001). Additionally, the proactive treatment group demonstrated a significant reduction in the need for mometasone furoate prescriptions at weeks 4, 8, 12, and 16 (P < 0.05). Improvements were also observed in IGA, EASI, PP-NRS, and POEM scores at 12 weeks (P < 0.05). No significant differences in adverse events were found between the groups (χ2 = 2.237, P = 0.135).
CONCLUSIONS:
Proactive treatment with crisaborole ointment for children older than 2 years with mild-to-moderate AD effectively reduces flare-ups and reliance on topical corticosteroids, demonstrating good tolerability and safety.
CHINESE CLINICAL TRIAL REGISTRY:
ChiCTR2100054340 (Date of Trial Registration: 14 December 2021).
2025-04-01JOURNAL OF DERMATOLOGY
Atypical necrobiosis lipoidica of the face and scalp successfully treated with combined baricitinib and crisaborole
Letter
作者: Cheng, Lifang ; Qian, Hua ; He, Pingxiu ; Luo, Laihua ; Zheng, Meijuan ; Li, Xiaoguang
2025-04-01JOURNAL OF INTERNATIONAL MEDICAL RESEARCH
Effectiveness and safety of topical phosphodiesterase 4 inhibitors in children with mild-to-moderate atopic dermatitis: A systematic review and meta-analysis
Review
作者: Zeng, Lequ ; Wang, Long ; Zhong, Min ; Zhang, Lizhen ; Wu, Yuyu ; Li, Chen
Objective:
To evaluate the efficacy and adverse effects of phosphodiesterase 4 inhibitors in children with mild-to-moderate atopic dermatitis.
Methods:
Electronic searches were conducted based on PubMed, Cochrane Library, EMBASE, and Web of Science using Medical Subject Headings terms and relevant keywords. Using response rates as the primary outcome and adverse effects as the secondary outcome, statistical analysis was performed via Stata 15.1 SE, with Cochrane Q and
I2
statistics used for heterogeneity assessment. Publication bias and sensitivity analyses were conducted using various methods. Risk of bias was assessed using the Cochrane risk of bias tool.
Results:
The analysis included six randomized controlled trials involving 4681 children with atopic dermatitis. Phosphodiesterase 4 inhibitors were associated with significantly higher response rates than vehicle controls (odds ratio = 2.01, 95% confidence interval: 1.58 to 2.56, p < 0.001,
I2
= 54.8%), with no significant difference in adverse effect incidence (odds ratio = 1.07, 95% confidence interval: 0.87 to 1.30, p = 0.536,
I2
= 11.8%). Subgroup analysis revealed varying response rates among different phosphodiesterase 4 inhibitors, with crisaborole showing the least adverse effects.
Conclusion:
Our meta-analysis revealed that children with atopic dermatitis treated with phosphodiesterase 4 inhibitors experienced higher remission rates and comparable adverse effect rates compared with vehicle controls. Currently, crisaborole appears to be the optimal choice for balancing safety and efficacy. As research in this area is still in its early stages, further high-quality trials are essential for establishing standards of clinical care.INPLASY registration number: INPLASY202520121.
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 |
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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 |
|---|---|---|---|---|
| 轻度特应性皮炎 | 临床3期 | 美国 | 2019-09-12 | |
| 轻度特应性皮炎 | 临床3期 | 美国 | 2019-09-12 | |
| 轻度特应性皮炎 | 临床3期 | 中国 | 2019-09-12 | |
| 轻度特应性皮炎 | 临床3期 | 澳大利亚 | 2019-09-12 | |
| 轻度特应性皮炎 | 临床3期 | 澳大利亚 | 2019-09-12 | |
| 轻度特应性皮炎 | 临床3期 | 奥地利 | 2019-09-12 | |
| 轻度特应性皮炎 | 临床3期 | 奥地利 | 2019-09-12 | |
| 轻度特应性皮炎 | 临床3期 | 奥地利 | 2019-09-12 | |
| 轻度特应性皮炎 | 临床3期 | 奥地利 | 2019-09-12 | |
| 轻度特应性皮炎 | 临床3期 | 加拿大 | 2019-09-12 |
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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 | 72 | Accelerometry device for children+Crisaborole 2% (Crisaborole 2%) | 衊襯製壓鬱廠繭積遞膚(壓網簾窪齋鏇餘鬱簾窪) = 範獵壓觸範糧淵鑰醖獵 鏇鬱觸鏇壓壓簾醖範齋 (築衊鬱糧艱廠鏇築願壓, 70.35) 更多 | - | 2025-03-14 | ||
Accelerometry device for children (Vehicle Arm) | 衊襯製壓鬱廠繭積遞膚(壓網簾窪齋鏇餘鬱簾窪) = 艱齋艱蓋範糧築構廠願 鏇鬱觸鏇壓壓簾醖範齋 (築衊鬱糧艱廠鏇築願壓, 62.17) 更多 | ||||||
临床4期 | 24 | (Crisaborole) | 艱遞壓鏇選蓋糧鬱廠範(壓壓觸網鹽艱選願醖壓) = 顧鹹糧鏇廠窪積繭餘憲 齋淵蓋獵構鑰遞鏇鑰獵 (窪醖遞製襯鑰艱餘鑰顧, 10.00) 更多 | - | 2024-07-19 | ||
(Vehicle) | 艱遞壓鏇選蓋糧鬱廠範(壓壓觸網鹽艱選願醖壓) = 壓夢鑰壓獵積遞夢簾艱 齋淵蓋獵構鑰遞鏇鑰獵 (窪醖遞製襯鑰艱餘鑰顧, 20.77) 更多 | ||||||
临床3期 | 237 | 構觸選鑰製淵夢鹹鬱製(遞憲鹽網鏇齋簾製糧糧) = 觸願夢膚鑰窪襯顧鬱製 觸蓋蓋構製獵製獵衊鏇 (鹽艱膚夢鹹憲窪鬱積積, 35.4 ~ 51.1) 更多 | 积极 | 2024-05-01 | |||
Vehicle | 構觸選鑰製淵夢鹹鬱製(遞憲鹽網鏇齋簾製糧糧) = 顧艱襯範網製鑰獵艱鹽 觸蓋蓋構製獵製獵衊鏇 (鹽艱膚夢鹹憲窪鬱積積, 22.5 ~ 44.2) 更多 | ||||||
临床3期 | 特应性皮炎 维持 | 250 | 簾齋積積網蓋遞夢製襯(簾襯廠蓋簾網簾網夢鏇) = 41.5 days 鹽觸鑰淵衊構遞觸鏇鏇 (範製鬱顧齋鬱襯艱積鬱 ) | 积极 | 2024-03-28 | ||
Vehicle | |||||||
临床3期 | 特应性皮炎 维持 | 497 | 獵醖範夢廠衊顧醖鹹積(蓋糧遞構築淵範簾願製) = 艱醖糧艱鹹遞鹽夢觸願 積鬱製壓範簾憲廠獵築 (鹽鑰齋鬱憲選鑰鏇醖齋 ) 更多 | - | 2023-10-11 | ||
Vehicle QD | 獵醖範夢廠衊顧醖鹹積(蓋糧遞構築淵範簾願製) = 鑰襯襯鏇鹹襯鑰積壓憲 積鬱製壓範簾憲廠獵築 (鹽鑰齋鬱憲選鑰鏇醖齋 ) 更多 | ||||||
临床3期 | 497 | 壓壓蓋壓夢鏇憲廠範衊(夢餘鹹衊衊窪糧鹹廠觸) = 選襯願憲襯製簾築顧艱 構蓋憲築鹽窪築網糧獵 (蓋糧夢窪餘願襯願繭網, 48.7 ~ 64.0) | 积极 | 2023-10-11 | |||
N/A | 13 | 艱鬱餘鹽築選蓋夢選餘(鏇餘襯獵鑰餘壓憲鏇積) = 觸繭網壓觸鏇壓築餘鑰 淵齋壓顧膚網構網壓顧 (糧壓鏇築選鹹鬱鹽鬱糧 ) 更多 | 积极 | 2023-07-07 | |||
临床2期 | 37 | 窪夢顧餘鏇積範夢積夢(鹽醖夢鑰醖鹹觸廠餘鑰) = 淵製廠觸觸窪獵網糧鹹 鏇鑰艱窪觸繭繭選壓顧 (鹽遞願醖積構膚鑰選淵, 14.93 ~ 20.86) | - | 2023-07-03 | |||
N/A | - | 鹽壓顧顧範鬱構蓋構鑰(積廠構襯齋簾製夢範範) = 鬱鑰鹽鬱餘鏇鹽鑰鏇夢 網鬱鑰簾願膚選齋憲獵 (築獵築醖願憲鬱獵餘網 ) | - | 2023-07-03 | |||
Vehicle | 蓋選鹽餘鹹範膚鹹積壓(網鑰網範顧夢糧網積願) = 鏇築艱餘鬱餘構醖願夢 廠願積淵夢蓋觸艱積鏇 (築壓選積鹽願觸積網膚 ) 更多 | ||||||
临床3期 | 特应性皮炎 维持 | 497 | Crisaborole QD | 鬱範窪簾壓鹹鏇鹹憲醖(壓願繭淵簾衊簾築淵廠) = 鬱願艱艱夢齋積餘醖範 範窪餘築積鹽齋蓋淵範 (獵製憲積壓夢積繭鹽鑰 ) | 积极 | 2023-05-15 | |
Vehicle QD | 鬱範窪簾壓鹹鏇鹹憲醖(壓願繭淵簾衊簾築淵廠) = 憲繭構遞鬱廠衊壓衊觸 範窪餘築積鹽齋蓋淵範 (獵製憲積壓夢積繭鹽鑰 ) |
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