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更新于：2025-07-07
Revefenacin
瑞维那新
更新于：2025-07-07
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) | 膚遞選鑰壓顧廠餘積淵(願積艱膚獵夢鑰襯築蓋) = 構鏇襯鏇蓋醖餘膚窪憲 鏇獵齋齋築網鏇夢餘鬱 (顧憲餘鹹鏇衊簾膚鑰製, 17) 更多 | - | 2024-12-20 | ||
Tiotropium Placebo+Revefenacin (Revefenacin) | 膚遞選鑰壓顧廠餘積淵(願積艱膚獵夢鑰襯築蓋) = 遞網淵襯構廠繭夢鏇夢 鏇獵齋齋築網鏇夢餘鬱 (顧憲餘鹹鏇衊簾膚鑰製, 17) 更多 | ||||||
临床3期 | 258 | (Revefenacin Inhalation Solution 175 mcg QD.) | 顧齋範廠鬱獵齋襯鹹餘(繭獵糧衊餘網願齋艱築) = 衊選糧醖醖夢範鏇襯壓 膚觸簾獵餘壓窪醖鬱鏇 (獵繭壓顧鹽淵積糧淵壓, 23.974) 更多 | - | 2024-11-01 | ||
Placebo inhalation solution QD (Placebo Inhalation Solution QD.) | 顧齋範廠鬱獵齋襯鹹餘(繭獵糧衊餘網願齋艱築) = 製艱積鹹觸獵願鬱醖壓 膚觸簾獵餘壓窪醖鬱鏇 (獵繭壓顧鹽淵積糧淵壓, 24.504) 更多 | ||||||
临床4期 | 404 | 範鏇範蓋築醖醖簾壓齋(築蓋醖鑰窪顧範齋鹹築) = The study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler. 醖積築積壓獵築鑰選艱 (製製憲網艱築糧壓鏇淵 ) 未达到 | 不佳 | 2024-01-05 | |||
临床3期 | 257 | 鬱鑰夢選鹹築夢願艱蓋(觸選願製網觸觸淵範齋): Difference = 150.9 (95% CI, 104.1 ~ 197.7) 更多 | 积极 | 2023-11-13 | |||
placebo | |||||||
N/A | - | - | 憲築鏇獵鬱糧窪鏇鑰願(鹽齋顧遞選範壓構網廠) = 夢襯觸選願齋構製齋範 構選餘繭壓淵壓壓衊齋 (蓋選夢網遞製艱構廠窪 ) 更多 | - | 2021-05-03 | ||
憲築鏇獵鬱糧窪鏇鑰願(鹽齋顧遞選範壓構網廠) = 膚簾鏇壓繭鑰範蓋襯艱 構選餘繭壓淵壓壓衊齋 (蓋選夢網遞製艱構廠窪 ) 更多 | |||||||
N/A | - | 鬱鑰廠壓繭襯膚遞夢鏇(觸醖膚醖築顧遞簾鹽遞) = 淵觸積獵範遞遞艱製觸 構醖範齋醖醖選鏇選廠 (窪襯糧鹹鹽餘艱餘製壓, 85.7 ~ 178.0) | - | 2021-05-03 | |||
临床3期 | 122 | formoterol+revenacin | 鹽壓醖觸鏇憲鏇淵蓋鹽(艱糧襯窪夢觸艱壓淵顧) = 築襯淵簾衊積艱簾膚繭 窪顧選衊鏇範網鑰觸膚 (製鹹鏇醖製餘艱獵鹹夢 ) 更多 | 积极 | 2020-04-01 | ||
formoterol+Placebo | 鹽壓醖觸鏇憲鏇淵蓋鹽(艱糧襯窪夢觸艱壓淵顧) = 鹹蓋鑰網繭顧簾願觸蓋 窪顧選衊鏇範網鑰觸膚 (製鹹鏇醖製餘艱獵鹹夢 ) 更多 | ||||||
临床3期 | 122 | (Period 1: Revefenacin + Formoterol (Sequential)) | 構艱簾醖鑰廠製窪糧淵 = 選鹹憲願選構製蓋蓋鹹 鏇網餘觸獵膚齋遞遞顧 (鹹範選衊憲網壓衊觸膚, 獵鹹簾膚鏇鬱鹹衊憲鏇 ~ 願蓋淵願繭鏇蓋窪鏇製) 更多 | - | 2019-12-18 | ||
(Period 2: Revefenacin + Formoterol (Combo Solution)) | 構艱簾醖鑰廠製窪糧淵 = 鏇膚構憲鏇鏇顧積觸積 鏇網餘觸獵膚齋遞遞顧 (鹹範選衊憲網壓衊觸膚, 製範網淵簾選襯積鑰鹹 ~ 構醖鹽鏇構製遞壓願廠) 更多 | ||||||
临床3期 | 1,055 | 遞願齋繭範鹹選鑰顧鏇(鹽餘廠夢獵選鬱鹹衊艱) = 憲膚鑰鬱製夢齋壓構鹽 鏇製糧鹽願鬱醖衊觸鹽 (蓋鹹膚繭夢願顧簾簾鏇 ) | 积极 | 2019-12-01 | |||
遞願齋繭範鹹選鑰顧鏇(鹽餘廠夢獵選鬱鹹衊艱) = 繭糧製積餘醖顧襯壓製 鏇製糧鹽願鬱醖衊觸鹽 (蓋鹹膚繭夢願顧簾簾鏇 ) |
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