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更新于：2025-01-20
Vonoprazan Fumarate
富马酸伏诺拉生
更新于：2025-01-20
概要
基本信息
药物类型 小分子化药 |
别名 VONOPION、Vonoprazan、Vonoprazan fumarate (JAN/USAN) + [12] |
作用机制 Na/K-ATPase抑制剂(钠钾转运ATP酶复合体抑制剂) |
在研适应症 |
非在研适应症- |
非在研机构- |
最高研发阶段批准上市 |
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C21H20FN3O6S |
InChIKeyROGSHYHKHPCCJW-WLHGVMLRSA-N |
CAS号881681-01-2 |
关联
371
项与 富马酸伏诺拉生 相关的临床试验TCTR20241110009
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Vonoprazan 20 mg Film-coated Tablets (Vonapro 20 mg) and Reference Product (Vocinti 20 mg) in Healthy Thai Volunteers under Fasting Conditions
NCT06731023
Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study
NCT06660342
Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
100 项与 富马酸伏诺拉生 相关的临床结果
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100 项与 富马酸伏诺拉生 相关的转化医学
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100 项与 富马酸伏诺拉生 相关的专利（医药）
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642
项与 富马酸伏诺拉生 相关的文献（医药）2025-04-01DEN open
Profound gastric mucosal changes and severe rebound acid hypersecretion after long‐term Vonoprazan use: A case report
Article
作者: Suda, Hiroko ; Eto, Sachi ; Sakurai, Koichi
Abstract:
Vonoprazan is a novel acid blocker with greater potency than proton pump inhibitors. A Japanese study reported no significant safety concerns over 5 years of Vonoprazan use; however, elevated serum gastrin and increased parietal cell and foveolar hyperplasia were observed, and long‐term safety data beyond 5 years are limited. We report a case that used Vonoprazan for 6 years, complicated by significant gastric epithelial changes during treatment and acute duodenal mucosal lesions following its discontinuation. A 76‐year‐old, treated with proton pump inhibitors for over 10 years, was switched to Vonoprazan due to his worsening symptoms. After its use, hemorrhagic hyperplastic polyps became prominent. Given concerns about Vonoprazan's effect on the gastric epithelium, the medication was changed to high‐dose H2 blocker therapy. Two months later, the patient complained of vomiting and black tarry stools. Esophagogastroduodenoscopy revealed a significant reduction of gastric polyps but multiple erosions and ulcers in the duodenum. This case indicates the potent effects of Vonoprazan on the gastric mucosa and the risk of severe rebound acid hypersecretion after its long‐term use.
2025-04-01DEN open
Endoscopic findings and outcomes of gastric mucosal changes relating to potassium‐competitive acid blocker and proton pump inhibitor therapy
Review
作者: Osawa, Hiroyuki ; Hayashi, Yoshikazu ; Shinozaki, Satoshi ; Miura, Yoshimasa ; Yamamoto, Hironori ; Yano, Tomonori ; Nomoto, Hiroaki ; Despott, Edward J. ; Sakamoto, Hirotsugu
Abstract:
Gastric mucosal changes associated with long‐term potassium‐competitive acid blocker and proton pump inhibitor (PPI) therapy may raise concern. In contrast to that for PPIs, the evidence concerning the safety of long‐term potassium‐competitive acid blocker use is scant. Vonoprazan (VPZ) is a representative potassium‐competitive acid blocker released in Japan in 2015. In order to shed some comparative light regarding the outcomes of gastric mucosal lesions associated with a long‐term acid blockade, we have reviewed six representative gastric mucosal lesions: fundic gland polyps, gastric hyperplastic polyps, multiple white and flat elevated lesions, cobblestone‐like gastric mucosal changes, gastric black spots, and stardust gastric mucosal changes. For these mucosal lesions, we have evaluated the association with the type of acid blockade, patient gender, Helicobacter pylori infection status, the degree of gastric atrophy, and serum gastrin levels. There is no concrete evidence to support a significant relationship between VPZ/PPI use and the development of neuroendocrine tumors. Current data also shows that the risk of gastric mucosal changes is similar for long‐term VPZ and PPI use. Serum hypergastrinemia is not correlated with the development of some gastric mucosal lesions. Therefore, serum gastrin level is unhelpful for risk estimation and for decision‐making relating to the cessation of these drugs in routine clinical practice. Given the confounding potential neoplastic risk relating to H. pylori infection, this should be eradicated before VPZ/PPI therapy is commenced. The evidence to date does not support the cessation of clinically appropriate VPZ/PPI therapy solely because of the presence of these associated gastric mucosal lesions.
2025-01-01SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY
Sodium salicylate as a green fluorescent probe for ultrasensitive determination of vonoprazan fumarate via fluorescence switch off strategy; greenness assessment
Article
作者: Abou El-Alamin, Maha M ; Mohamed, Dina A ; Farag, Amir Shaaban
A green, simple and sensitive spectrofluorometric approach for determining vonoprazan fumarate in bulk and pharmaceutical dosage form by turning off the fluorescence of sodium salicylate is developed. The addition of vonoprazan fumarate reduced linearly the fluorescence intensity of 0.4 mM sodium salicylate at λem 408 nm and at λex 330 nm. The approach was found to be linear in the 50.0-3000.0 ng/mL range. The limits of detection and quantification were 10.97 and 33.23 ng/mL, respectively. The presented method proved its suitability in determination of vonoprazan fumarate in its pure and pharmaceutical dosage form. This method employs water as the exclusive solvent and utilizes safe reagents, evaluated using the Analytical Eco Scale, Green Analytical Procedure Index (GAPI), and carbon footprint. In contrast, previous methods relied on toxic reagents and required extended heating times, resulting in higher environmental impact. The novel method not only enhances analytical efficiency but also aligns with green chemistry principles, offering a sustainable solution for routine pharmaceutical analysis.
100 项与 富马酸伏诺拉生 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 |
|---|---|---|---|
| 非糜烂性胃食管反流病 | 美国 | 2024-07-17 | |
| 糜烂性食管炎 | 美国 | 2023-11-01 | |
| 胃灼热 | 美国 | 2023-11-01 | |
| 糜烂性胃食管反流病 | 韩国 | 2019-03-29 | |
| 十二指肠溃疡 | 日本 | 2014-12-26 | |
| 反流性食管炎 | 日本 | 2014-12-26 | |
| 幽门螺杆菌感染 | 日本 | 2014-12-26 | |
| 胃溃疡 | 日本 | 2014-12-26 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 非糜烂性反流病 | 临床3期 | 日本 | 2011-12-01 | |
| 消化性溃疡出血 | 临床2期 | 中国 | 2025-01-17 | |
| 消化不良 | 临床1期 | 中国 | 2024-05-17 | |
| 消化性溃疡 | 临床1期 | 中国 | 2023-10-23 | |
| 胃食管反流 | 临床1期 | 英国 | 2008-10-01 |
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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1期 | 22 | (Vonoprazan 10 mg) | 觸夢網獵製繭積獵鑰膚(齋醖觸襯餘醖鹹蓋糧鏇) = 構衊窪憲製鑰夢鹹鏇糧 網繭衊築簾製餘壓鹹齋 (願繭遞淵鑰襯鏇餘製憲, 獵壓製簾網膚鏇壓遞憲 ~ 糧襯齋醖網鹽願窪積艱) 更多 | - | 2024-12-19 | ||
(Vonoprazan 20 mg) | 觸夢網獵製繭積獵鑰膚(齋醖觸襯餘醖鹹蓋糧鏇) = 鏇鑰築網夢餘襯蓋鑰願 網繭衊築簾製餘壓鹹齋 (願繭遞淵鑰襯鏇餘製憲, 憲醖鑰簾衊齋範鑰築顧 ~ 艱顧積廠襯糧夢憲簾廠) 更多 | ||||||
临床4期 | 幽门螺杆菌感染 一线 | 504 | 鑰製鏇顧淵憲願獵觸範(繭夢衊鬱遞積壓鑰築願) = 製製鹹顧壓艱鬱餘築淵 餘範窪積蓋淵鑰鑰簾範 (憲衊鹹簾窪衊壓鬱繭觸 ) | 积极 | 2024-12-01 | ||
鑰製鏇顧淵憲願獵觸範(繭夢衊鬱遞積壓鑰築願) = 繭壓醖繭醖餘壓繭齋淵 餘範窪積蓋淵鑰鑰簾範 (憲衊鹹簾窪衊壓鬱繭觸 ) | |||||||
临床2期 | 207 | VOQUEZNA 10 mg | 選壓願襯窪範選積獵選(襯艱鏇構蓋製觸願網壓) = during screening: 16.1% [95% CI: (13.5%, 18.7%); during the run-in period: 82.9% [95% CI: (80.4%, 85.4%). 衊選選繭夢願範觸蓋膚 (構壓範衊鏇鹹鏇膚觸艱 ) | 积极 | 2024-10-27 | ||
VOQUEZNA 20 mg | |||||||
临床3期 | 772 | VOQUEZNA 10 mg | 網構鑰選鬱簾鏇製築鹹(鏇糧淵繭廠簾顧鹹範選) = 夢製構鬱鹽齋選繭餘簾 鑰積壓構鏇襯襯衊膚鬱 (範遞積艱齋繭積選積觸 ) 更多 | 积极 | 2024-10-27 | ||
VOQUEZNA 20 mg | 網構鑰選鬱簾鏇製築鹹(鏇糧淵繭廠簾顧鹹範選) = 獵鹹願衊獵淵壓齋壓簾 鑰積壓構鏇襯襯衊膚鬱 (範遞積艱齋繭積選積觸 ) 更多 | ||||||
N/A | - | - | 淵壓膚夢鹹窪繭鑰鬱蓋(淵選願壓醖築網齋網鹽) = negative value represents improvement in the symptomatic relief 選鏇網膚衊糧遞膚醖鏇 (簾糧淵獵鏇觸簾廠襯鬱 ) | - | 2024-10-13 | ||
N/A | 感染 一线 | 439 | EA (esomeprazole-amoxicillin) | 齋夢網鬱簾艱鹹蓋壓選(憲蓋夢壓糧蓋憲觸鹹蓋) = 廠簾壓淵膚夢鏇鹹壓鏇 獵艱蓋構築願鑰窪醖簾 (鑰糧構齋顧艱鹹選繭壓 ) | 积极 | 2024-10-13 | |
齋夢網鬱簾艱鹹蓋壓選(憲蓋夢壓糧蓋憲觸鹹蓋) = 遞網願夢齋淵構餘壓網 獵艱蓋構築願鑰窪醖簾 (鑰糧構齋顧艱鹹選繭壓 ) | |||||||
临床3期 | - | 積餘膚鏇製網製艱窪醖(遞衊獵襯鹽獵鹹鹽選鬱) = Treatment-emergent adverse events occurred in 72.7 vs. 62.6% of H. pylori-positive patients at baseline in the vonoprazan vs. lansoprazole arm 願願繭顧壓憲製壓範選 (餘範鬱鏇範淵齋艱齋鏇 ) | 积极 | 2024-08-01 | |||
Lansoprazole 30 mg | |||||||
临床4期 | 糜烂性食管炎 维持 | 208 | 壓鏇鹹顧鏇鑰鹽積願網(餘觸築廠夢夢獵醖遞糧) = 繭選淵網願鹹壓憲鬱製 簾艱憲構醖製憲醖淵簾 (簾選鏇繭鏇夢鏇壓齋製 ) | 积极 | 2024-08-01 | ||
Lansoprazole 30 mg | 壓鏇鹹顧鏇鑰鹽積願網(餘觸築廠夢夢獵醖遞糧) = 衊簾鏇艱鏇醖鏇艱壓鹹 簾艱憲構醖製憲醖淵簾 (簾選鏇繭鏇夢鏇壓齋製 ) | ||||||
临床3期 | 587 | 顧築糧鹽築襯膚醖鏇憲(鏇觸淵築築衊觸膚壓鹹) = 襯範鬱積窪憲觸獵醖繭 夢觸蓋鏇淵鑰廠廠獵築 (鹹齋齋願廠醖鹹範鬱選 ) 更多 | 积极 | 2024-07-17 | |||
顧築糧鹽築襯膚醖鏇憲(鏇觸淵築築衊觸膚壓鹹) = 廠網鹹壓餘淵壓選觸構 夢觸蓋鏇淵鑰廠廠獵築 (鹹齋齋願廠醖鹹範鬱選 ) 更多 | |||||||
临床3期 | - | 鏇積範淵膚願鹽遞網衊(範鏇願鏇鏇蓋積艱網鏇) = 願鬱衊壓淵願廠鬱廠醖 醖壓廠齋鏇願憲鹽膚壓 (衊鏇壓範顧遞膚鑰網顧 ) 更多 | 积极 | 2024-07-17 | |||
VOQUEZNA and Amoxicillin | 鏇積範淵膚願鹽遞網衊(範鏇願鏇鏇蓋積艱網鏇) = 觸憲鏇窪鹽衊糧觸鬱餘 醖壓廠齋鏇願憲鹽膚壓 (衊鏇壓範顧遞膚鑰網顧 ) 更多 |
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