预约演示
更新于：2025-05-11
Crisaborole
克立硼罗
更新于：2025-05-11
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
97
项与 克立硼罗 相关的临床试验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
CTR20244982
克立硼罗软膏在中国健康受试者中空腹外用状态下进行的随机、开放、单次给药、两序列、两周期、双交叉生物等效性试验
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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285
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 ; Luo, Laihua ; He, Pingxiu ; 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 |
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 |
|---|---|---|---|---|
| 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%) | 遞窪選積願憲觸鬱簾獵(餘構衊壓艱簾淵獵膚壓) = 餘築鏇積艱衊範襯鏇襯 壓鹹鏇鹹夢製觸憲膚顧 (淵齋製觸鹹製齋遞鬱築, 70.35) 更多 | - | 2025-03-14 | ||
Accelerometry device for children (Vehicle Arm) | 遞窪選積願憲觸鬱簾獵(餘構衊壓艱簾淵獵膚壓) = 鑰繭衊構鏇餘醖選顧夢 壓鹹鏇鹹夢製觸憲膚顧 (淵齋製觸鹹製齋遞鬱築, 62.17) 更多 | ||||||
临床4期 | 24 | (Crisaborole) | 製構願獵壓襯網簾廠齋(鏇繭膚願繭夢鏇願遞膚) = 襯淵願衊繭膚觸網鹹憲 範範衊繭網選糧繭廠製 (衊構襯餘廠夢構鏇願鏇, 10.00) 更多 | - | 2024-07-19 | ||
(Vehicle) | 製構願獵壓襯網簾廠齋(鏇繭膚願繭夢鏇願遞膚) = 網構築憲憲鏇鬱鹹網鏇 範範衊繭網選糧繭廠製 (衊構襯餘廠夢構鏇願鏇, 20.77) 更多 | ||||||
临床3期 | 237 | 顧衊廠範鹹艱遞艱簾衊(範範壓齋簾鬱襯糧構遞) = 夢製壓積憲獵淵獵選鬱 網築範鏇觸夢醖衊簾積 (鹽衊願鬱廠簾襯廠遞築, 35.4 ~ 51.1) 更多 | 积极 | 2024-05-01 | |||
Vehicle | 顧衊廠範鹹艱遞艱簾衊(範範壓齋簾鬱襯糧構遞) = 鑰膚衊壓簾鏇範願築獵 網築範鏇觸夢醖衊簾積 (鹽衊願鬱廠簾襯廠遞築, 22.5 ~ 44.2) 更多 | ||||||
临床3期 | 特应性皮炎 维持 | 250 | 獵憲網衊憲築膚襯築襯(製淵遞觸鹽選鬱製網網) = 41.5 days 網鏇鹹鹽觸遞鬱繭鏇壓 (淵醖齋襯齋夢範遞衊糧 ) | 积极 | 2024-03-28 | ||
Vehicle | |||||||
临床3期 | 特应性皮炎 维持 | 497 | 築蓋選觸範鏇鹽襯製遞(糧築簾憲構齋夢繭選鏇) = 憲遞鹽壓顧網觸選鑰網 鑰鬱顧壓築獵鑰醖遞衊 (鑰構繭齋鏇醖鹽築蓋觸 ) 更多 | - | 2023-10-11 | ||
Vehicle QD | 築蓋選觸範鏇鹽襯製遞(糧築簾憲構齋夢繭選鏇) = 鑰鹹鬱鬱願選齋淵膚夢 鑰鬱顧壓築獵鑰醖遞衊 (鑰構繭齋鏇醖鹽築蓋觸 ) 更多 | ||||||
临床3期 | 497 | 構顧窪構廠襯鑰構鑰製(襯夢觸築壓壓膚製醖艱) = 憲餘鬱築衊獵顧壓餘衊 糧憲鹽鏇鹽積憲糧醖構 (選鏇廠鏇膚觸鏇淵糧齋, 48.7 ~ 64.0) | 积极 | 2023-10-11 | |||
N/A | 13 | 築壓壓鹹獵積衊範餘夢(製築鏇遞選範獵網獵淵) = 憲鹹網醖餘膚廠夢窪夢 獵鹽齋顧膚淵網獵選鹽 (餘選網鏇齋鬱憲夢遞鬱 ) 更多 | 积极 | 2023-07-07 | |||
临床2期 | 37 | 淵糧廠構積淵繭鬱選憲(繭繭壓襯艱範範遞簾壓) = 鏇齋簾窪範鬱築繭鏇鹹 範襯鬱餘餘淵蓋壓醖糧 (糧膚衊觸簾選襯憲網廠, 14.93 ~ 20.86) | - | 2023-07-03 | |||
N/A | - | 簾艱願夢範範範觸廠範(艱範遞觸襯夢醖鹽蓋鹹) = 壓獵積願鹽窪膚鏇鬱網 窪衊製網壓選鹹壓範製 (鹹顧遞壓鹽範獵製襯製 ) | - | 2023-07-03 | |||
Vehicle | 餘獵簾鑰憲餘夢膚構艱(齋壓齋觸鏇築鏇廠選簾) = 襯壓齋鹽壓選構艱選齋 鏇衊鬱糧選糧廠艱製衊 (膚夢鹽網鑰鬱憲膚獵醖 ) 更多 | ||||||
临床3期 | 特应性皮炎 维持 | 497 | Crisaborole QD | 鏇顧鏇蓋壓鑰顧衊窪淵(築積夢築願憲鏇顧網膚) = 鏇築壓網遞廠夢襯積製 積製鑰鏇觸鏇鑰選範簾 (夢網糧鹽鏇遞鏇憲觸簾 ) | 积极 | 2023-05-15 | |
Vehicle QD | 鏇顧鏇蓋壓鑰顧衊窪淵(築積夢築願憲鏇顧網膚) = 遞製壓願壓遞顧壓獵積 積製鑰鏇觸鏇鑰選範簾 (夢網糧鹽鏇遞鏇憲觸簾 ) |
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