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更新于：2025-07-15
Revefenacin
瑞维那新
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 (2018-11-09), |
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C35H43N5O4 |
InChIKeyFYDWDCIFZSGNBU-UHFFFAOYSA-N |
CAS号864750-70-9 |
关联
20
项与 瑞维那新 相关的临床试验CTRI/2022/09/045402
A Double-Blind, placebo-controlled study of nebulized revefenacin inhalation solution in Indian Subjects with moderate to very severe chronic obstructive pulmonary disease (COPD).
NCT05165485
A Phase 4, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Study Comparing Improvements in Lung Function in Adults With Severe to Very Severe Chronic Obstructive Pulmonary Disease and Suboptimal Inspiratory Flow Rate Following Once-Daily Treatment Over 12 Weeks With Either Revefenacin Inhalation Solution Delivered Via Standard Jet Nebulizer or Tiotropium Delivered Via a Dry Powder Inhaler (Spiriva® HandiHaler®)
NCT05046795
A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study of Nebulized Revefenacin Inhalation Solution in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD).
100 项与 瑞维那新 相关的临床结果
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100 项与 瑞维那新 相关的转化医学
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100 项与 瑞维那新 相关的专利（医药）
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60
项与 瑞维那新 相关的文献（医药）2025-09-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Development of a novel stability-indicating UHPLC method for revefenacin quality control and impurity identification using 2D-LC-HRMS
Article
作者: Xu, Nuo ; Xiao, Chaoqiang ; Guo, Wei ; Sun, Lu ; Zhou, Sunxin ; Zhang, Weifeng ; He, Shuwang ; Zhang, Tong
Revefenacin (Rev) inhalation solution is the only once-daily nebulized bronchodilator approved in the USA for chronic obstructive pulmonary disease treatment. Despite the critical role of quality control in pharmaceutical manufacturing, no established methods exist for Rev, and its degradation pathways remain unreported. This study performed forced degradation to generate impurity-containing samples, which were used to develop a novel ultrahigh-performance liquid chromatography (UHPLC) method. Qualitative analysis of 12 impurities was conducted using two-dimensional liquid chromatography-high-resolution mass spectrometry. Characteristic fragment ions and mass fragmentation processes were examined, leading to the identification and verification of four specific impurities using reference standards. Impurities A (C₂₂H₃₃N₃O₄), B (C₃₅H₄₂N₄O₅), and C (C₁₂H₁₁N) were identified definitively by comparison to reference materials, while DP-9 and DP-11 were tentatively identified based on MS studies. The remaining seven impurities were not identified due to concentrations below the identification threshold. The primary degradation pathways of Rev were oxidation and hydrolysis. The UHPLC method achieved baseline separation of the 12 degradation products (DPs), and its effectiveness was confirmed by assessing sample stability under the proposed chromatographic conditions. The results demonstrate that this method is suitable for Rev quality control. The novel stability-indicating UHPLC method developed for quantifying Rev DPs offers a reliable approach for quality assurance.
2025-03-07Cureus Journal of Medical Science
Nebulized Long-Acting Bronchodilators to Treat Acute Respiratory Failure in an Older Adult: A Case Report
Article
作者: North, Avery ; Helwig, Katelyn ; Fuller, Jordan ; Boylan, Paul M ; Gibbs, Macie
This report describes the case of a 79-year-old man admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure due to coronavirus disease 2019 (COVID-19) and treated with long-acting nebulized bronchodilators, arformoterol and revefenacin. This article aimed to assess the use of long-acting nebulized bronchodilators in an older adult with acute respiratory failure. The institutional setting was a 500-bed academic medical center in the southern US. Arformoterol is a long-acting beta agonist (LABA) and revefenacin is a long-acting muscarinic antagonist (LAMA), both approved to treat stable chronic obstructive pulmonary disease (COPD). Neither medication is US Food and Drug Administration approved for acute respiratory failure. In this case, both medications were used for their rapid-onset and long-duration bronchodilator activity to treat acute respiratory failure secondary to COVID-19. This older adult clinically improved within three days of nebulized long-acting bronchodilator use.
2025-02-01BIOORGANIC CHEMISTRY
Identification of mitoxantrone as a potent inhibitor of CDK7/Cyclin H via structure-based virtual screening and In-Vitro validation by ADP-Glo kinase assay
Article
作者: Patekar, Rohan R ; Bharate, Sandip B ; Somarowthu, Tejaswi
Cyclin-dependent kinases, CDK7 and CDK9 play critical roles in cancer by regulating transcriptional processes essential for cell proliferation and survival. Their dysregulation leads to aberrant gene expression, promoting oncogenic pathways and contributing to tumor growth and progression. This study aimed to identify a new chemotype for CDK7/9 inhibitors using a structure-based virtual screening approach. Our research led to the discovery of mitoxantrone as an inhibitor of CDK7/H and CDK9/T1 from a library of FDA-approved small molecule drugs. Mitoxantrone, a chemotherapy agent used to treat acute nonlymphocytic leukemia, works by disrupting DNA synthesis and repair, thus inhibiting cancer cell growth. The study found that mitoxantrone effectively inhibits both CDK7/H and CDK9/T1 with IC50 values of 0.675 µM and 5.15 µM, respectively, while showing no inhibition of CDK2/E1 (IC50 > 100 µM) in in-vitro ADP-Glo kinase assay. It binds to the ATP pocket of CDK7 and CDK9, forming crucial H-bonds with MET 94 and CYS 106, respectively. It achieves dock scores of - 12.93 and - 12.59 kcal/mol, and MMGBSA binding energies of - 82.87 and - 81.59 kcal/mol, respectively. Molecular dynamics simulations over 100 ns confirmed stable interactions with MET 94 and CYS 106 in the hinge region of CDK7 and CDK9. The active site sequence alignment helped to understand the differential activity of mitoxantrone for CDK7, 9 and 2 inhibitions. The findings of the paper reveal a novel mechanism of mitoxantrone action that may contribute to its anticancer efficacy.
100 项与 瑞维那新 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 |
|---|---|---|---|
| 慢性阻塞性肺疾病 | 美国 | 2018-11-09 |
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 |
|---|---|---|---|---|
| 呼吸衰竭 | 临床2期 | 美国 | 2020-11-01 | |
| 呼吸衰竭 | 临床2期 | 美国 | 2020-11-01 | |
| 呼吸功能不全 | 临床2期 | 美国 | 2020-11-01 | |
| 呼吸功能不全 | 临床2期 | 美国 | 2020-11-01 | |
| 肾功能不全 | 临床1期 | 美国 | 2015-12-01 | |
| 肾功能不全 | 临床1期 | 美国 | 2015-12-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 404 | Revefenacin Placebo+Tiotropium (Tiotropium) | 網繭鏇衊壓膚鹽齋鹹餘(膚選醖顧夢鹹餘觸窪衊) = 醖鏇鹹網廠繭鏇醖鬱鹽 淵夢鹽齋鬱獵遞衊醖窪 (糧醖製襯繭觸淵艱夢糧, 17) 更多 | - | 2024-12-20 | ||
Tiotropium Placebo+Revefenacin (Revefenacin) | 網繭鏇衊壓膚鹽齋鹹餘(膚選醖顧夢鹹餘觸窪衊) = 襯蓋範簾觸鑰鬱獵衊鹽 淵夢鹽齋鬱獵遞衊醖窪 (糧醖製襯繭觸淵艱夢糧, 17) 更多 | ||||||
临床3期 | 258 | (Revefenacin Inhalation Solution 175 mcg QD.) | 觸構憲遞選選衊製繭廠(蓋艱蓋醖範築製選願範) = 窪獵餘衊齋壓襯範廠鬱 獵築鹽餘鬱願糧鏇構鏇 (淵選醖築壓壓鹹襯窪製, 23.974) 更多 | - | 2024-11-01 | ||
Placebo inhalation solution QD (Placebo Inhalation Solution QD.) | 觸構憲遞選選衊製繭廠(蓋艱蓋醖範築製選願範) = 範製鏇製範襯簾鬱製夢 獵築鹽餘鬱願糧鏇構鏇 (淵選醖築壓壓鹹襯窪製, 24.504) 更多 | ||||||
临床4期 | 404 | 觸膚窪鏇願積淵簾鏇簾(簾壓憲淵觸繭鹹窪遞壓) = The study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler. 簾艱鑰鹽網鑰獵繭遞餘 (夢願憲夢襯襯夢繭願製 ) 未达到 | 不佳 | 2024-01-05 | |||
临床3期 | 257 | 築網淵糧襯築衊餘遞襯(簾網壓衊窪艱簾壓鏇遞): Difference = 150.9 (95% CI, 104.1 ~ 197.7) 更多 | 积极 | 2023-11-13 | |||
placebo | |||||||
N/A | - | 膚蓋鹽窪夢膚觸鹹鹹鬱(積憲獵醖構積衊構餘選) = 積壓鏇觸範鹽齋淵範醖 憲獵鹹壓構蓋糧餘醖膚 (構網蓋鬱憲顧鏇襯艱鑰, 85.7 ~ 178.0) | - | 2021-05-03 | |||
N/A | - | - | 遞觸鹹選齋製艱夢糧餘(網艱網顧夢範製製繭膚) = 艱餘遞淵繭範選齋積衊 鹹觸鹹窪願淵襯製鹽鏇 (廠製壓遞蓋襯範網鏇鹽 ) 更多 | - | 2021-05-03 | ||
遞觸鹹選齋製艱夢糧餘(網艱網顧夢範製製繭膚) = 積選膚簾製簾窪夢醖廠 鹹觸鹹窪願淵襯製鹽鏇 (廠製壓遞蓋襯範網鏇鹽 ) 更多 | |||||||
临床3期 | 122 | formoterol+revenacin | 餘憲廠齋鹹夢網糧觸繭(願廠淵餘獵鏇鬱鹽顧壓) = 鏇遞願餘製製壓衊蓋觸 觸顧醖簾選艱構窪鏇積 (衊艱繭夢夢簾膚築壓壓 ) 更多 | 积极 | 2020-04-01 | ||
formoterol+Placebo | 餘憲廠齋鹹夢網糧觸繭(願廠淵餘獵鏇鬱鹽顧壓) = 獵繭醖獵鬱淵糧艱廠範 觸顧醖簾選艱構窪鏇積 (衊艱繭夢夢簾膚築壓壓 ) 更多 | ||||||
临床3期 | 122 | (Period 1: Revefenacin + Formoterol (Sequential)) | 餘選襯憲憲顧夢獵網獵 = 齋鏇鑰網鑰艱襯製艱襯 鑰構淵憲襯齋範膚窪壓 (鑰簾簾鏇鏇艱鬱憲鹹糧, 簾遞淵憲築願範顧膚顧 ~ 窪壓簾鹹廠餘築醖衊窪) 更多 | - | 2019-12-18 | ||
(Period 2: Revefenacin + Formoterol (Combo Solution)) | 餘選襯憲憲顧夢獵網獵 = 襯鹹築蓋糧壓窪鹹積壓 鑰構淵憲襯齋範膚窪壓 (鑰簾簾鏇鏇艱鬱憲鹹糧, 顧積鏇製積觸構築醖淵 ~ 鬱鹽廠淵構築選襯鑰繭) 更多 | ||||||
临床3期 | 1,055 | 廠繭鹹鑰鏇獵範醖鏇獵(鹽網醖鹽蓋網齋繭淵構) = 餘願鑰艱構鏇製繭選顧 遞蓋餘壓繭蓋壓鑰獵憲 (壓構窪築淵壓繭憲窪製 ) | 积极 | 2019-12-01 | |||
廠繭鹹鑰鏇獵範醖鏇獵(鹽網醖鹽蓋網齋繭淵構) = 鹽廠繭廠築憲網簾憲製 遞蓋餘壓繭蓋壓鑰獵憲 (壓構窪築淵壓繭憲窪製 ) |
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