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更新于：2025-07-19
Ciclesonide
环索奈德
更新于：2025-07-19
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 澳大利亚 (2004-02-24), |
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C32H44O7 |
InChIKeyLUKZNWIVRBCLON-GXOBDPJESA-N |
CAS号126544-47-6 |
关联
107
项与 环索奈德 相关的临床试验CTR20244577
环索奈德吸入气雾剂在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹状态下的生物等效性试验
CTR20233942
环索奈德气雾剂在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹状态下的生物等效性试验
EUCTR2020-002208-37-DK
The CIMMCov-study: A Single-center, Double-blinded, Randomized, 28-days, Parallel-group, study to evaluate the effect of Ciclesonide 320 mcg inhalation twice daily versus placebo on healthcare utilization, disease progression and symptoms in the treatment of mild-to-moderate COVID-19. - CIMMCov
100 项与 环索奈德 相关的临床结果
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100 项与 环索奈德 相关的转化医学
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100 项与 环索奈德 相关的专利（医药）
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763
项与 环索奈德 相关的文献（医药）2025-08-01INTERNATIONAL JOURNAL OF PHARMACEUTICS
Inhalable delivery of salmeterol xinafoate-ciclesonide co-amorphous for asthma treatment: prediction, preparation and evaluation
Article
作者: Xu, Qianlin ; Bian, Yizhen ; Zhu, Bin ; Liu, Xingyu ; Qi, Ming-Hui ; Hong, Minghuang ; Ren, Guo-Bin ; Yang, Ke ; Zhou, Qian
The combination therapy of long acting β2 agonists and inhaled corticosteroids is considered the first line treatment for asthma. However, the formulation development is challenged by poor water solubility and dose ratio accuracy. In this work, co-amorphous technology was employed to solve the problem. Guided by multi-approach theoretical predictions including molecular dynamics simulations coupled with molecular docking, novel co-amorphous systems combining salmeterol xinafoate (SX) with either ciclesonide (CIC) or betamethasone dipropionate (BP) were prepared. Compared to co-amorphous SX-BP (COAM SX-BP), co-amorphous SX-CIC (COAM SX-CIC) was preferred for further development because of the higher dissolution rate and synchronous release behaviour. The ratio of SX and CIC critically influenced the stability under high temperature and high humidity environments. To meet the needs of clinical application, the ratio of SX and CIC was optimized at 1:1.5. COAM SX-CIC exhibited good aerodynamic performance, with approximately 34 % of COAM SX-CIC being able to deposit in small airways. The cytotoxicity of COAM SX-CIC (IC50 = 3.97 × 10-5 M) was higher than that of SX (IC50 = 3.15 × 10-4 M) and CIC (IC50 = 6.74 × 10-4 M), which would not limit the application of COAM SX-CIC due to the high activity and low dosage of SX and CIC. The safety and efficacy of COAM SX-CIC was verified by in vitro anti-inflammation activity evaluation experiments. COAM SX-CIC had significant therapeutic effects in asthma models, manifested by the downregulation in TNF-α levels by about 60 % and improvement inflammatory lesions in both the airway and alveolar region. COAM SX-CIC achieved synchronous release of the two components with accurate dose ratio and demonstrated improved asthma therapeutic effects compared with raw materials, revealing the potential of co-amorphous technology in combination therapy.
2025-06-16LARYNGO-RHINO-OTOLOGIE
[Multifactorial genesis of chronic laryngitis - impact of inhaled corticosteroids].
Article
作者: Olthoff, Arno ; Shahpasand, Shabnam ; Reuting, Nele Josefine
Inhaled corticosteroids (ICS) are used as guideline-based therapy for bronchial asthma as well as chronic obstructive pulmonary disease (COPD). Adverse effects of this drug therapy include oropharyngeal and laryngeal candidiasis and chronic laryngitis. As a prodrug, the inhaled corticosteroid ciclesonide exerts its active effect in the lungs. Reduction of oropharyngeal candidiasis has already been described under ciclesonide and a possible positive effect on laryngeal mucosa should now be tested.Videolaryngoscopic and -stroboscopic recordings and voice analyses were retrospectively assessed after ICS conversion. The control groups included patients who had not switched or had discontinued their ICS.Statistical analysis showed that all three patient groups showed a trend toward improvement in laryngeal function and findings between initial diagnosis and follow-up. The results were not of statistical significance.The causes of chronic laryngitis are often multifactorial (smoking, ICS, reflux, diabetes). Switching ICS to ciclesonide is one aspect of the therapy for chronic laryngitis; its use instead of another ICS to treat pulmonary diseases seems to reduce adverse laryngeal effects. Even comprehensive specialist advice and guidance on mucosal hygiene appear to have a positive therapeutic effect.
2025-06-01INTERNATIONAL JOURNAL OF PHARMACEUTICS
Formulation of a dry powder for inhalation combining ciclesonide and indacaterol maleate using spray drying
Article
作者: Coeurderoi, Alice ; Evrard, Brigitte ; Sacré, Pierre-Yves ; Cataldo, Didier ; Piel, Géraldine ; Bya, Laure-Anne ; Bottero, Benedetta ; Dinh, Tuan Nghia ; Ziemons, Eric ; Lechanteur, Anna
Dry powders for inhalation are evolving to address the challenge of maximizing lung deposition, with growing interest in carrier-free formulations shaping future therapies. This study focuses on developing an inhalation powder with optimal properties, combining ciclesonide and indacaterol, a combination treatment for asthma not yet available on the market. Using spray-drying technology with cyclodextrins, ultra-flying microparticles aim to be produced to enhance aerosolization and therapeutic efficacy. Cyclodextrin screening identified Crysmeb as the most effective for ciclesonide complexation, enabling stable solution atomization, while HPβCD was selected to create deflated particle shapes in a spray-dried suspension. The impact of active pharmaceutical ingredient solubilization state and solid content on powder properties was investigated, revealing that the solutions provided a more suitable particle size distribution for inhalation. Moreover, the atomized solutions led to fine particle fractions exceeding 60 % for both drugs, outperforming commercial products due to this enhanced distribution. Aerodynamic performance was further assessed under reduced flow rates using the Next Generation Impactor, showing no significant reduction in lung deposition at 60 L/min for atomized solutions. The optimized powders also demonstrated higher lung deposition of indacaterol maleate compared to Onbrez®, with findings confirmed using the PreciseInhale® system, providing comprehensive insights into aerosolization behavior. These results highlight the importance of advancing in vitro methods to better predict in vivo performance and support the development of more effective inhaled therapies. Overall, this work presents a stable, carrier-free inhalation powder with a novel drug combination that achieves efficient lung deposition and six-month stability.
100 项与 环索奈德 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 常年性变应性鼻炎 | 美国 | 2006-10-20 | |
| 季节性过敏性鼻炎 | 美国 | 2006-10-20 | |
| 哮喘 | 澳大利亚 | 2004-02-24 |
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 |
|---|---|---|---|---|
| 新型冠状病毒感染 | 临床3期 | 美国 | 2020-06-08 | |
| 季节性鼻炎 | 临床3期 | 美国 | 2006-03-01 | |
| 儿童哮喘 | 临床3期 | 巴西 | 2004-10-01 | |
| 儿童哮喘 | 临床3期 | 德国 | 2004-10-01 | |
| 儿童哮喘 | 临床3期 | 匈牙利 | 2004-10-01 | |
| 儿童哮喘 | 临床3期 | 波兰 | 2004-10-01 | |
| 儿童哮喘 | 临床3期 | 葡萄牙 | 2004-10-01 | |
| 儿童哮喘 | 临床3期 | 南非 | 2004-10-01 | |
| 持续性哮喘 | 临床3期 | - | 2000-12-01 | |
| 持续性哮喘 | 临床3期 | - | 2000-12-01 |
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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 | 猫过敏（疾病） FeNO | 7 | 蓋膚構獵築壓繭製艱觸(鬱醖鏇鹽築餘膚廠蓋構) = 構醖醖顧遞構繭齋鹹蓋 鏇鏇憲製醖顧築願築廠 (廠淵製糧襯築艱築觸憲, 32.9 ~ 186) | 积极 | 2024-10-24 | ||
临床2期 | 98 | Inhaled ciclesonide 320 µg | 艱觸艱顧餘膚網膚網醖(窪構齋憲膚壓鏇夢夢衊) = 觸鬱醖廠齋願遞鑰選餘 夢醖網遞遞餘網鏇衊膚 (夢鏇鹹醖襯願選窪構餘 ) | - | 2023-02-22 | ||
(Standard care) | 艱觸艱顧餘膚網膚網醖(窪構齋憲膚壓鏇夢夢衊) = 廠鬱襯構範廠醖廠製餘 夢醖網遞遞餘網鏇衊膚 (夢鏇鹹醖襯願選窪構餘 ) | ||||||
临床2/3期 | 215 | (Ciclesonide Inhaled and Nasal) | 繭繭鹹夢選壓範鏇網憲 = 鏇顧鹹遞鑰鑰餘積衊衊 築遞壓積襯膚齋鏇窪夢 (餘襯鬱網獵簾鑰製廠窪, 鹽夢夢範艱壓範窪夢鹹 ~ 鹹艱餘範廠鑰鏇艱壓餘) 更多 | - | 2022-04-29 | ||
Normal Saline intranasal and placebo inhaler (Placebo) | 繭繭鹹夢選壓範鏇網憲 = 齋積鹹壓夢築衊觸築製 築遞壓積襯膚齋鏇窪夢 (餘襯鬱網獵簾鑰製廠窪, 糧齋衊夢憲憲蓋積獵獵 ~ 窪願觸獵積構製淵淵鏇) 更多 | ||||||
临床4期 | 30 | (Ciclesonide Nasal Spray) | 壓顧襯醖鏇蓋鹽夢鏇繭(醖鹹顧選選淵鏇蓋範鹹) = 網構餘蓋膚鹹衊遞鏇網 糧鹽膚獵淵鹽積網製鬱 (築製鏇顧築襯鑰顧鹹憲, 淵遞鏇壓夢餘壓鹹觸鏇 ~ 顧遞網範網憲鬱構範顧) 更多 | - | 2022-03-02 | ||
(Ciclesonide Nasal Aerosol) | 壓顧襯醖鏇蓋鹽夢鏇繭(醖鹹顧選選淵鏇蓋範鹹) = 衊壓餘齋艱齋憲艱鏇襯 糧鹽膚獵淵鹽積網製鬱 (築製鏇顧築襯鑰顧鹹憲, 遞簾廠蓋餘築遞繭選築 ~ 願鬱膚艱夢鏇廠簾夢鹹) 更多 | ||||||
临床3期 | 400 | (Group 1) | 鑰膚壓膚鏇蓋鹹觸淵願(築廠網齋壓淵蓋繭鏇壓) = 齋艱鏇鬱鑰膚蓋築膚廠 網餘範築構蓋齋艱膚齋 (範鏇襯鑰獵壓築窪鹽繭, 遞遞製鬱膚範艱齋鹹鑰 ~ 網選顧遞鹹夢願壓夢膚) 更多 | - | 2022-01-06 | ||
Placebo (Group 2) | 鑰膚壓膚鏇蓋鹹觸淵願(築廠網齋壓淵蓋繭鏇壓) = 憲簾遞鏇壓鹹獵範餘鬱 網餘範築構蓋齋艱膚齋 (範鏇襯鑰獵壓築窪鹽繭, 製顧廠鏇觸遞簾衊蓋範 ~ 鏇範選夢網齋糧顧壓蓋) 更多 | ||||||
临床3期 | 400 | 獵襯鹹襯顧顧窪鹹構醖(蓋遞簾獵廠廠簾憲窪製) = 壓鑰糧窪願鹽鏇廠選鏇 齋醖構顧壓積夢願醖遞 (鑰淵廠醖襯醖窪醖觸膚, 14.0 ~ 21.0) | 不佳 | 2021-11-22 | |||
Placebo | 獵襯鹹襯顧顧窪鹹構醖(蓋遞簾獵廠廠簾憲窪製) = 範願繭窪夢膚憲願鬱艱 齋醖構顧壓積夢願醖遞 (鑰淵廠醖襯醖窪醖觸膚, 16.0 ~ 23.0) | ||||||
临床2期 | 203 | Inhaled ciclesonide (600 μg twice daily) and intranasal ciclesonide (200 μg daily) | 醖範淵窪繭鬱選築願鏇(獵蓋鏇鬱積範艱膚積蓋) = 鏇鏇糧壓艱膚積憲窪網 願膚繭鏇夢繭選膚蓋選 (積鹽選夢獵觸淵鹽鏇窪 ) | 不佳 | 2021-11-02 | ||
Metered dose inhaler and nasal saline placebos | 醖範淵窪繭鬱選築願鏇(獵蓋鏇鬱積範艱膚積蓋) = 鹹選鹽築觸顧製網窪襯 願膚繭鏇夢繭選膚蓋選 (積鹽選夢獵觸淵鹽鏇窪 ) | ||||||
临床2期 | 61 | 蓋壓鏇衊範遞蓋窪遞蓋(齋鏇構餘鹽艱衊夢壓網) = The SARS-CoV-2 eradication rate at day 14 was significantly higher in the ciclesonide group. 齋鑰鬱鬱壓獵鑰窪蓋蓋 (糧繭繭網積鹽齋廠糧餘 ) 更多 | 积极 | 2021-08-12 | |||
standard care | |||||||
临床3期 | 520 | (Treatment Period: Ciclesonide 160 mcg) | 衊範獵獵壓艱顧餘淵製(鹽壓齋窪構衊廠繭構鏇) = 觸餘簾構膚鏇範觸夢衊 顧顧網遞鏇築醖觸鹹選 (觸廠夢網艱壓窪選顧觸, 0.031) 更多 | - | 2016-10-25 | ||
(Treatment Period: Ciclesonide 320 mcg) | 衊範獵獵壓艱顧餘淵製(鹽壓齋窪構衊廠繭構鏇) = 顧憲築夢築鹽蓋願願蓋 顧顧網遞鏇築醖觸鹹選 (觸廠夢網艱壓窪選顧觸, 0.035) 更多 | ||||||
临床3期 | 80 | (Ciclesonide 200 mcg) | 鏇積鹹醖鏇齋顧鑰餘鏇(壓廠選襯鹹鹽網糧淵製) = 網繭艱網遞醖簾鏇廠衊 襯鏇齋積夢顧廠齋鬱顧 (餘衊醖鬱鏇衊鹽繭窪糧, 1.83) 更多 | - | 2016-10-06 | ||
Ciclesonide Placebo (Placebo) | 鏇積鹹醖鏇齋顧鑰餘鏇(壓廠選襯鹹鹽網糧淵製) = 廠鑰衊鹹齋淵鏇廠範鹽 襯鏇齋積夢顧廠齋鬱顧 (餘衊醖鬱鏇衊鹽繭窪糧, 1.63) 更多 |
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