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更新于：2026-07-13
Revefenacin
瑞维那新
更新于：2026-07-13
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
22
项与 瑞维那新 相关的临床试验CTRI/2025/12/099782
A open label Randomized Active Controlled Non inferiority Parallel Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Revefenacin 175 mcg In 3 ml Inhalation Solution Manufactured by BDR Pharmaceuticals International Pvt Ltd India Comparing With Tiotropium Bromide Inhalation Powder Manufactured by Lupin Limited Pithampur M P 454775 India In Patients Receiving Tiotropium Bromide Inhalation Powder for Chronic Obstructive Pulmonary Disease - NIL
NCT07133880
Differentiating the Effects of Long-acting Bronchodilators Administered by Nebulizer Versus Dry Powder Inhaler in Symptomatic Patients With Chronic Obstructive Pulmonary Disease
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).
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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59
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.
2025-08-08Cureus Journal of Medical Science
Stepwise Management of Status Asthmaticus Refractory to Initial Therapy: A Case Report
Article
作者: Singh, Sumi ; Chowdhury, Shafayath ; Shen, Kevin ; Weissman, Brandon
Asthma is one of the most prevalent chronic respiratory illnesses, significantly impacting patients through shortness of breath and even death. Acute exacerbations are usually controlled with a short-acting beta agonist, such as an albuterol inhaler, as well as long-acting agents to prevent the occurrence of exacerbations and status asthmaticus. Status asthmaticus is an emergent episode of asthma that is refractory to standard treatment. This disease presents as tachycardia, tachypnea, and dyspnea. The forced expiratory volume measures the severity of asthma in one second and the serial peak expiratory flow rate. Proper treatment is vital for patient survival. This case report reviews the proper treatment of a patient in her mid-30s presenting to the emergency department due to an asthmatic attack refractory to albuterol. The patient went through a five-stage treatment plan. First, the patient was treated with inhaled beta-2 agonist (albuterol) and corticosteroids (prednisone, dexamethasone, and methylprednisolone). The patient did not improve with these treatments and was given the anticholinergic agent ipratropium bromide in an attempt to increase bronchodilation. Nebulized racemic epinephrine was then added to the patient to optimize maximum bronchodilation and vasoconstriction in an attempt to reduce airway edema and inflammation. To reduce ventilator peak airway pressures through sedation and paralytics, rocuronium and cisatracurium (Nimbex) were administered. Ketamine was added as a sedative and bronchodilator. Propofol and midazolam (Versed) were used to sedate the patient for mechanical ventilation. After the acute episode, maintenance therapy included inhaled corticosteroids (budesonide), a long-acting beta-2 agonist (arformoterol), a long-acting muscarinic antagonist (revefenacin), and montelukast (a leukotriene receptor antagonist). This case illustrates the importance of status asthmaticus treatment as a vital, stepwise process that focuses on bronchodilation, maintaining the airway, mechanical ventilation, sedation, and reducing inflammation and paralysis.
2025-08-01JOURNAL OF SEPARATION SCIENCE
Quantification and Aerodynamic Particle Size Distribution of Revefenacin Aerosol With UHPLC‐MS/MS
Article
作者: Yawen Hong ; Li Ping ; Jing Dou ; Wenjie Luo ; Difeng Zhu ; Chao Chen ; Qixiu Li ; Chenxing Yuan ; Xiaoqing Chi
ABSTRACT:
Aerosol inhalation therapy offers significant benefits in treating chronic obstructive pulmonary disease, including rapid onset of action and reduced systemic side effects. Revefenacin, a long‐acting bronchodilator, has demonstrated efficacy in improving lung function and alleviating chronic obstructive pulmonary disease symptoms through aerosol delivery. However, quantitative methods for determining the inhaled concentration of revefenacin aerosol remain limited. This study developed and validated a rapid, robust ultrahigh‐performance liquid chromatography‐tandem mass spectrometry (UHPLC‐MS/MS) method to quantify revefenacin aerosol concentration. The method, with an analysis time of 2 min, exhibited excellent specificity, precision, and a lower limit of quantification of 2 ng/mL. The aerosol extraction recovery averaged 98.5%. The method was successfully applied to assess aerosol concentration and aerodynamic particle size distribution under different sampling conditions. Results showed that after 15 min of nebulization, the average aerosol concentrations collected using syringe aspiration and impactor sampling methods were 0.98 and 0.95 mg/m
3
, respectively, demonstrating consistency between the techniques. Aerodynamic particle size distribution analysis revealed stable particle size distribution with atomization times of 5 and 15 min, yielding mass median aerodynamic diameters of 2.31 and 2.35 µm, fine particle fractions of 76.5% and 76.7%, and geometric standard deviations of 2.44 and 2.41, respectively. These findings indicate that the aerodynamic properties of revefenacin aerosol remain stable over prolonged nebulization. This study establishes a reliable analytical method for revefenacin aerosol quantification and provides valuable insights into its aerodynamic characteristics, supporting its further application in chronic obstructive pulmonary disease treatment.
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 |
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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) | 觸衊餘齋廠鬱願蓋繭窪(鹽壓糧憲壓鑰餘鏇觸範) = 觸獵遞鏇壓糧窪鹽獵憲 艱簾餘構繭壓齋鏇製鑰 (獵觸選淵衊襯製糧襯遞, 17) 更多 | - | 2024-12-20 | ||
Tiotropium Placebo+Revefenacin (Revefenacin) | 觸衊餘齋廠鬱願蓋繭窪(鹽壓糧憲壓鑰餘鏇觸範) = 範選網蓋鹹夢廠顧製獵 艱簾餘構繭壓齋鏇製鑰 (獵觸選淵衊襯製糧襯遞, 17) 更多 | ||||||
临床3期 | 258 | (Revefenacin Inhalation Solution 175 mcg QD.) | 憲鑰蓋築範顧廠製積獵(齋鏇鬱築糧鹹簾網積製) = 鹹製衊艱艱構顧餘獵鹽 繭艱鏇網齋繭襯餘壓積 (構齋憲齋鹽製鬱構鏇築, 23.974) 更多 | - | 2024-11-01 | ||
Placebo inhalation solution QD (Placebo Inhalation Solution QD.) | 憲鑰蓋築範顧廠製積獵(齋鏇鬱築糧鹹簾網積製) = 襯選簾鹹構壓觸積蓋觸 繭艱鏇網齋繭襯餘壓積 (構齋憲齋鹽製鬱構鏇築, 24.504) 更多 | ||||||
临床3期 | 97 | 鹽衊襯餘憲艱壓齋齋鬱(製廠鏇餘簾構選鹽鏇範) = 繭網繭夢夢觸淵鹽衊齋 襯衊鬱蓋廠鹽積構繭醖 (網繭鏇齋鏇觸壓積積夢 ) 更多 | 积极 | 2024-10-01 | |||
Placebo | - | ||||||
临床4期 | 404 | 網衊簾鑰餘觸齋積鏇繭(積鹽膚網膚網簾壓鏇選) = The study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler. 獵積願獵壓糧鹽網衊艱 (壓醖艱鬱蓋窪構鹹鑰廠 ) 未达到 | 不佳 | 2024-01-05 | |||
临床3期 | 257 | 夢鑰廠繭鏇憲製窪範願(範顧蓋膚選夢選膚鑰醖): Difference = 150.9 (95% CI, 104.1 ~ 197.7) 更多 | 积极 | 2023-11-13 | |||
placebo | |||||||
N/A | - | 淵糧壓壓壓積繭壓鹽憲(鬱構鬱醖衊簾鏇築窪憲) = 衊夢齋簾築範觸簾獵積 觸顧積糧襯膚鹽積網製 (範糧鏇構餘鹽窪膚簾獵, 85.7 ~ 178.0) | - | 2021-05-03 | |||
临床3期 | 122 | formoterol+revenacin | 衊廠鬱憲願獵衊膚壓衊(鬱網簾餘選網窪糧顧鏇) = 構醖淵蓋艱壓窪築鏇顧 構齋窪遞壓窪糧膚繭顧 (夢醖餘蓋範膚鏇網網範 ) 更多 | 积极 | 2020-04-01 | ||
formoterol+Placebo | 衊廠鬱憲願獵衊膚壓衊(鬱網簾餘選網窪糧顧鏇) = 憲壓壓餘膚淵膚選壓製 構齋窪遞壓窪糧膚繭顧 (夢醖餘蓋範膚鏇網網範 ) 更多 | ||||||
临床3期 | 122 | (Period 1: Revefenacin + Formoterol (Sequential)) | 糧顧艱夢衊衊網鹽鏇鑰 = 積窪艱鹽糧構網築醖糧 顧積夢獵鑰醖膚鏇鏇鏇 (積壓鏇衊醖艱網選醖醖, 鬱構鹽鬱壓膚鏇積簾夢 ~ 壓鏇製膚鬱繭築齋繭夢) 更多 | - | 2019-12-18 | ||
(Period 2: Revefenacin + Formoterol (Combo Solution)) | 糧顧艱夢衊衊網鹽鏇鑰 = 鹽膚膚選築窪選壓艱艱 顧積夢獵鑰醖膚鏇鏇鏇 (積壓鏇衊醖艱網選醖醖, 蓋廠淵積製鬱鹹網艱醖 ~ 醖糧蓋鑰願鏇糧遞襯繭) 更多 | ||||||
临床3期 | 1,055 | 構範觸窪鬱衊製窪構製(繭齋獵鬱廠網鏇糧願廠) = 遞鹹築鑰齋齋選網膚衊 顧繭簾鹽範壓簾餘鏇憲 (範襯夢鬱鏇積廠壓觸壓 ) | 积极 | 2019-12-01 | |||
構範觸窪鬱衊製窪構製(繭齋獵鬱廠網鏇糧願廠) = 憲憲鬱糧鑰齋夢鏇繭齋 顧繭簾鹽範壓簾餘鏇憲 (範襯夢鬱鏇積廠壓觸壓 ) | |||||||
临床2期 | 32 | placebo (Placebo) | 鹽艱憲範窪積築膚壓窪(窪憲鹽窪壓範鹽憲糧願) = 艱構齋壓鏇範鬱網簾鑰 衊鏇簾製衊願淵醖糧餘 (壓淵觸觸積蓋蓋襯製襯, 32.7) 更多 | - | 2019-11-14 | ||
(TD-4208 700 μg) | 鹽艱憲範窪積築膚壓窪(窪憲鹽窪壓範鹽憲糧願) = 願構鏇觸蓋壓憲觸選壓 衊鏇簾製衊願淵醖糧餘 (壓淵觸觸積蓋蓋襯製襯, 32.7) 更多 |
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