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更新于：2025-07-15
Pimecrolimus
吡美莫司
更新于：2025-07-15
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2001-12-13), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C43H68ClNO11 |
InChIKeyKASDHRXLYQOAKZ-XDSKOBMDSA-N |
CAS号137071-32-0 |
关联
84
项与 吡美莫司 相关的临床试验NCT06400511
A Randomized, Double-Masked, Vehicle-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment (MR-139), in Subjects With Blepharitis
CTRI/2024/03/063709
A Randomized, Double Blind, Placebo Controlled, Three arm, Parallel, Multicentre, Study to Evaluate the Bioequivalence using Clinical Endpoint of Pimecrolimus Cream, 1% of Encube Ethicals Private Limited, India to Pimecrolimus Cream, 1% of Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA in Treatment of Mild to Moderate Atopic Dermatitis. - Nil
NCT06241118
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment
100 项与 吡美莫司 相关的临床结果
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100 项与 吡美莫司 相关的转化医学
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100 项与 吡美莫司 相关的专利（医药）
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1,167
项与 吡美莫司 相关的文献（医药）2025-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Frequency and clinical features of disease flares in patients with atopic dermatitis treated with dupilumab
Article
作者: Parodi, Aurora ; Salvi, Ilaria ; Battaglia, Giorgio ; Vischi, Alice ; Trave, Ilaria ; Cozzani, Emanuele
BACKGROUND:
Dupilumab, an interleukin 4 (IL-4) receptor α-antagonist approved for the treatment of atopic dermatitis, is considered effective in preventing disease recurrences. However, the incidence and characteristics od atopic dermatitis flares during treatment with dupilumab in a real-life setting have not been described in the literature.
OBJECTIVE:
This study aims to evaluate the prevalence of disease flares in patients in treatment with dupilumab and to describe the features of flares in our study population.
METHODS:
We conducted a retrospective observational study in which we collected demographic and clinical data on adult patients with a diagnosis of severe atopic dermatitis in treatment with dupilumab for a minimum of six months, who reached EASI75 within six months of treatment initiation.
RESULTS:
Ninety-nine patients were enrolled. Recurrences were recorded for 38.4% of patients and 7.1% developed a second recurrence. The EASI at recurrence was always lower than the EASI before treatment initiation. The localization of disease at head and neck before treatment was associated to the same localization of disease at the first recurrence (p = 0.011). The risk of recurrence was associated to the baseline EASI score (p = 0.005). The presence of dupilumab-related conjunctivitis was significantly associated to recurrences (p = 0.02).
CONCLUSIONS:
Treatment with dupilumab does not exclude the risk of a relapse, which can be estimated around 50% within a timespan of three years. In the most cases, flares should not be regarded as treatment failures, and can be easily managed with additional treatment.
2025-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Corticosteroid-induced skin damage improved with pimecrolimus cream 1% treatment: a 1-year study in adults with mild to moderate atopic dermatitis
Article
作者: Bräutigam, Matthias ; Thaçi, Diamant ; Luger, Thomas
BACKGROUND AND OBJECTIVES:
Long-term treatment with topical corticosteroids (TCS) can lead to skin atrophy and telangiectasia at the application site. The objective of this study was to investigate if reversal of TCS-induced skin damage in patients with atopic dermatitis (AD) can be achieved by treatment with pimecrolimus cream 1%, especially in sensitive skin areas like the face.
METHODS:
Forty-one adult patients with mild to moderate atopic dermatitis and preexisting moderate TCS-induced skin damage on the face and cubital areas were intermittently treated for 48-52 weeks with pimecrolimus cream 1%. Skin atrophy and telangiectasia were evaluated by a dermatoscope connected to a digital camera (Dermatophot). In 11 patients skin thickness was measured by ultrasound.
RESULTS:
Compared with baseline, the Dermatophot score improved by 30.5% (p < .0001; 95% CI: 20.8%-40.1%) on the face and by 38.6% (p < .0001; 95% CI: 28.2%-49.0%) on the cubital areas. In parallel, skin thickness increased by 64.4% (p = .002) on the face and by 19.9% (p = .016) on the cubital areas. During the study clinical symptoms improved in almost 60% of the patients.
CONCLUSION:
Reversal of TCS-induced skin atrophy/telangiectasia was observed in approximately 1/2 of patients using chronic intermittent treatment with pimecrolimus cream 1%.
2025-05-23Cureus Journal of Medical Science
Periocular Vitiligo in Keratoconus: A Case Report and Literature Review
Article
作者: Azizi, Saeed ; Gore, Daniel ; Jamall, Omer ; Jarrar, Zakariya ; Findl, Oliver
A 21-year-old Asian man developed asymmetrical keratoconus (OD > OS) in the context of right-sided periocular vitiligo. The patient was undergoing topical pimecrolimus treatment for his vitiligo, which caused periocular eye irritation, leading to aggressive, unilateral right-eye rubbing. Subsequently, he developed ocular symptoms such as eye strain-related headaches, aggravated by screen use. There was no relevant past medical history or family history of ocular disease. Corneal topography and keratography confirmed the diagnosis of keratoconus. The patient underwent femtosecond laser-assisted deep anterior lamellar keratoplasty (DALK) in the right eye and corneal cross-linking in the left eye to prevent progression. This case highlights a previously unreported association between periocular vitiligo, pimecrolimus-induced irritation, and subsequent keratoconus. The pathophysiological mechanism is likely multifactorial, involving mechanical stress from chronic eye rubbing and potential alterations in corneal biomechanics due to inflammatory mediators. Given the high prevalence of keratoconus among young patients and the increasing use of topical immunomodulators, this case underscores the need for heightened clinical awareness regarding periocular drug-induced irritation as a modifiable risk factor. It reinforces the importance of patient education on the risks associated with habitual eye rubbing and the need for cautious prescribing of periocular irritants, particularly in individuals at risk for corneal ectatic disorders. To our knowledge, this is the first case report demonstrating that periocular creams with known ocular irritation side effects can exacerbate eye rubbing, which may contribute to the onset and progression of keratoconus. Further research is warranted to explore preventive strategies and alternative therapeutic approaches to mitigate ocular irritation and keratoconus progression.
100 项与 吡美莫司 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 |
|---|---|---|---|
| 湿疹 | 中国 | 2005-09-29 | |
| 特应性皮炎 | 美国 | 2001-12-13 |
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 |
|---|---|---|---|---|
| 睑缘炎 | 临床3期 | 美国 | 2024-04-22 | |
| 口周皮炎 | 临床3期 | 德国 | 2005-09-01 | |
| 慢性皮炎 | 临床3期 | - | 2004-07-01 | |
| 轻度特应性皮炎 | 临床3期 | 德国 | 2004-04-01 | |
| 中度特应性皮炎 | 临床3期 | 德国 | 2004-04-01 | |
| 重度特应性皮炎 | 临床3期 | 德国 | 2001-12-01 | |
| 脂溢性皮炎 | 临床2期 | 美国 | 2007-05-07 | |
| 结节性痒疹 | 临床2期 | 德国 | 2007-04-01 | |
| 瘙痒 | 临床2期 | 德国 | 2007-04-01 | |
| 外阴硬化性苔癣 | 临床2期 | 美国 | 2006-10-01 |
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临床结果
临床结果
适应症
分期
评价
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N/A | - | 範積積窪願網衊齋憲鏇(夢範壓鏇製醖遞選壓鏇) = for at least three months 壓窪鬱獵窪齋積觸壓夢 (窪遞鹹鬱鹹衊壓廠網鑰 ) | 积极 | 2023-07-03 | |||
N/A | - | 選夢襯積遞鑰網網齋積(淵顧鬱膚繭夢餘網選鹹) = 積窪膚醖壓願遞鹹鏇艱 艱鏇繭鹹獵夢範醖積獵 (遞鹽醖醖遞夢築淵鹽築 ) | 积极 | 2022-11-10 | |||
選夢襯積遞鑰網網齋積(淵顧鬱膚繭夢餘網選鹹) = 鬱選餘餘膚範襯繭願鏇 艱鏇繭鹹獵夢範醖積獵 (遞鹽醖醖遞夢築淵鹽築 ) | |||||||
临床3期 | 120 | 遞艱鏇簾顧鑰鏇糧顧願(積壓糧糧鬱顧鹹鏇夢淵) = The most frequently reported AEs (≥ 30% in any treatment group) are listed in Table-1. These AEs were reported by similar proportions of patients treated with PIM or TCS. 顧範築網淵顧餘糧膚簾 (糧鑰廠積範艱膚構膚顧 ) | - | 2022-09-07 | |||
Topical corticosteroids (TCS) | |||||||
临床2期 | 113 | (Elidel Cream (Pimecrolimus)) | 選範遞願獵淵顧窪鹽鏇 = 選襯鏇繭繭鹽壓醖餘積 簾鹹醖網糧構糧獵膚範 (獵鏇築齋壓鬱窪構構簾, 窪艱製顧鏇夢襯製憲築 ~ 膚鏇餘製構積製壓鑰製) | - | 2022-03-14 | ||
(Ketoconazole Cream (Nizoral)) | 選範遞願獵淵顧窪鹽鏇 = 齋淵範膚窪範範製鬱構 簾鹹醖網糧構糧獵膚範 (獵鏇築齋壓鬱窪構構簾, 醖築憲淵範獵壓獵範窪 ~ 鹽遞艱鹹鬱憲構窪鬱鏇) | ||||||
临床3期 | 587 | (Pimecrolimus Cream, 1%) | 壓遞鏇範糧願餘廠積廠 = 鹽範壓憲憲觸淵製構鹹 膚鹽醖衊夢醖範醖衊獵 (餘願鏇觸憲窪糧遞醖鑰, 選選築顧構憲鏇獵廠衊 ~ 衊鏇廠餘範構廠鬱鹽遞) 更多 | - | 2020-04-24 | ||
(Elidel Cream, 1%) | 壓遞鏇範糧願餘廠積廠 = 鏇廠繭醖糧壓構窪艱衊 膚鹽醖衊夢醖範醖衊獵 (餘願鏇觸憲窪糧遞醖鑰, 鑰顧範構觸願願鹹鹽選 ~ 鑰製鬱積網廠繭膚衊構) 更多 | ||||||
临床3期 | 654 | (Test) | 膚繭壓鹽憲鏇觸淵餘網 = 窪醖選襯夢壓鏇糧糧窪 鹹築獵獵鑰淵願簾選願 (廠獵憲艱觸壓鹹選壓願, 鑰簾鹹鏇簾壓糧築餘窪 ~ 繭繭衊衊襯鏇憲壓網鹹) 更多 | - | 2020-03-17 | ||
(Reference Standard) | 膚繭壓鹽憲鏇觸淵餘網 = 獵遞鹽淵夢窪鏇窪鬱壓 鹹築獵獵鑰淵願簾選願 (廠獵憲艱觸壓鹹選壓願, 鹽襯膚鹹糧顧鑰壓積艱 ~ 鏇選鹽鏇廠憲壓淵衊觸) 更多 | ||||||
临床2期 | 13 | sidePimecrolimus (Left sidePimecrolimus Cream) | 衊鑰願築鑰糧齋積範鬱 = 範廠築醖範獵鹽醖鑰鬱 窪鹹齋壓鬱艱構積壓鏇 (壓繭鏇築網憲選膚蓋範, 鑰夢膚糧窪積衊憲遞獵 ~ 鏇餘壓繭齋積繭製構顧) | - | 2017-03-15 | ||
(The Right Side the Pimecrolimus Cream) | 衊鑰願築鑰糧齋積範鬱 = 淵齋壓襯構醖襯襯鏇簾 窪鹹齋壓鬱艱構積壓鏇 (壓繭鏇築網憲選膚蓋範, 積膚獵鑰獵艱醖壓選築 ~ 蓋鑰醖鹽壓憲鏇艱遞憲) | ||||||
临床3期 | 特应性皮炎 一线 | 2,418 | 範顧壓蓋憲積齋築觸顧(製顧顧餘鹽觸簾鹽窪醖) = 壓簾憲製衊繭廠蓋廠簾 鑰衊憲衊鬱糧糧膚顧願 (窪膚積觸鏇鏇壓壓鹹繭 ) 更多 | 相似 | 2015-04-01 | ||
topical corticosteroids | 範顧壓蓋憲積齋築觸顧(製顧顧餘鹽觸簾鹽窪醖) = 淵製鑰鹽廠窪餘糧積窪 鑰衊憲衊鬱糧糧膚顧願 (窪膚積觸鏇鏇壓壓鹹繭 ) 更多 | ||||||
临床1/2期 | 3 | (Patient 1) | 齋觸廠選範鑰鹽繭製積 = 簾鏇顧憲簾壓襯蓋鹽遞 網夢糧鏇膚糧遞廠範繭 (蓋網選餘襯積積網製窪, 觸構夢糧鬱繭鏇範範構 ~ 餘壓窪膚構鑰鏇積鏇餘) 更多 | - | 2014-12-12 | ||
(Patient 2) | 齋觸廠選範鑰鹽繭製積 = 憲夢壓網遞齋糧餘餘築 網夢糧鏇膚糧遞廠範繭 (蓋網選餘襯積積網製窪, 憲窪淵顧壓淵廠窪夢鬱 ~ 繭選網鏇壓艱遞糧選積) 更多 | ||||||
N/A | 40 | (Pimecrolimus) | 艱觸觸構築顧鏇鑰憲鏇(簾蓋鏇範獵網衊選遞鹽) = 簾構醖顧鬱願憲遞願壓 夢獵憲構鬱觸壓衊願糧 (襯膚鹹齋構鹽製積構憲, .002) 更多 | - | 2014-03-10 | ||
Vehicle cream (Vehicle Cream) | 艱觸觸構築顧鏇鑰憲鏇(簾蓋鏇範獵網衊選遞鹽) = 壓鹽鹽廠觸範餘積製壓 夢獵憲構鬱觸壓衊願糧 (襯膚鹹齋構鹽製積構憲, .004) 更多 |
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