更新于：2024-11-04
Vonoprazan Fumarate
富马酸伏诺拉生
更新于：2024-11-04
概要
基本信息
药物类型 小分子化药 |
别名 VONOPION、Vonoprazan、Vonoprazan fumarate (JAN/USAN) + [11] |
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
分子式C21H20FN3O6S |
InChIKeyROGSHYHKHPCCJW-WLHGVMLRSA-N |
CAS号881681-01-2 |
关联
353
项与 富马酸伏诺拉生 相关的临床试验A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Vonoprazan 20 mg Film-coated Tablets (POLIPRAZAN 20) and Reference Product (VOCINTI 20 mg) in Healthy Thai Volunteers under Fasting Conditions
Clinical efficacy analysis of Vonoprazan in the treatment of pharyngeal reflux disease
Comparison of Vonoprazan based therapy vs Standard Quadruple therapy for eradication of Helicobacter pylori - nil
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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603
项与 富马酸伏诺拉生 相关的文献（医药）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 ; Miura, Yoshimasa ; Shinozaki, Satoshi ; 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.
2024-11-01Clinical Gastroenterology and Hepatology
Vonoprazan is Efficacious for Treatment of Heartburn in Non-erosive Reflux Disease: A Randomized Trial
Article
作者: Smith, Neila ; Yadlapati, Rena ; Spechler, Stuart ; Fass, Ronnie ; Hunt, Barbara ; Laine, Loren ; Leifke, Eckhard ; Harris, Tom ; Schnoll-Sussman, Felice ; Katz, Philip
BACKGROUND & AIMS:
Potassium-competitive acid blockers have documented efficacy for erosive esophagitis. We performed a randomized trial in United States subjects diagnosed with non-erosive reflux disease of vonoprazan vs placebo for 4 weeks, followed by a 20-week active-treatment extension.
METHODS:
Adult subjects with heartburn ≥4 days/week during screening without erosive esophagitis on endoscopy were randomized to placebo, vonoprazan 10 mg, or vonoprazan 20 mg. After 4 weeks, subjects on placebo were re-randomized to vonoprazan 10 mg or 20 mg, and those already on vonoprazan continued at the same dose for 20 weeks. Electronic diaries were completed twice daily. The primary endpoint was percentage of days without daytime or nighttime heartburn (24-hour heartburn-free days).
RESULTS:
Among 772 randomized subjects, the percentage of 24-hour heartburn-free days was 27.7% for placebo vs 44.8% for vonoprazan 10 mg (least squares mean difference, 17.1%; P < .0001) and 44.4% for vonoprazan 20 mg (least squares mean difference, 16.7%; P < .0001). Differences in percentage of subjects with a 24-hour heartburn-free day for vonoprazan 10 mg vs placebo and vonoprazan 20 mg vs placebo were 8.3% and 11.6% on day 1 and 18.1% and 23.2% on day 2. The mean/median percentages of 24-hour heartburn-free days over the extension period were similar across the 4 study arms: 61%-63%/76%-79%.
CONCLUSIONS:
Vonoprazan reduced heartburn symptoms in subjects diagnosed with non-erosive reflux disease, with the benefit appearing to begin as early as the first day of therapy. Treatment effect persisted after the initial 4-week placebo-controlled period throughout the 20-week extension period. The 2 vonoprazan doses (10 mg and 20 mg) were similar in efficacy. (ClinicalTrials.gov: NCT05195528).
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
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 |
|---|---|---|---|---|
| 非糜烂性反流病 | 临床3期 | 日本 | 2011-12-01 | |
| 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 | |
| 消化性溃疡出血 | 临床1期 | 中国 | 2022-08-09 | |
| 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3期 | 772 | VOQUEZNA 10 mg | 醖鏇鑰齋廠顧簾網鏇衊(餘醖衊遞鑰憲範衊顧襯) = 夢築願觸壓廠襯鹽糧選 鏇鹽網餘繭夢艱鏇憲製 (壓鹹淵鹹網膚壓廠網觸 ) 更多 | 积极 | 2024-10-27 | ||
VOQUEZNA 20 mg | 醖鏇鑰齋廠顧簾網鏇衊(餘醖衊遞鑰憲範衊顧襯) = 願齋襯壓願範構蓋夢築 鏇鹽網餘繭夢艱鏇憲製 (壓鹹淵鹹網膚壓廠網觸 ) 更多 | ||||||
临床2期 | 207 | VOQUEZNA 10 mg | 鹹簾夢艱鹹鑰窪餘顧夢(糧鏇遞夢遞膚鑰網選蓋) = during screening: 16.1% [95% CI: (13.5%, 18.7%); during the run-in period: 82.9% [95% CI: (80.4%, 85.4%). 壓鏇糧廠艱鹹蓋積憲衊 (襯遞齋衊壓遞鏇繭鹹遞 ) | 积极 | 2024-10-27 | ||
VOQUEZNA 20 mg | |||||||
临床3期 | - | 築憲範積網鹽顧鏇簾鬱(範遞壓獵壓鹽襯齋鹽鏇) = Treatment-emergent adverse events occurred in 72.7 vs. 62.6% of H. pylori-positive patients at baseline in the vonoprazan vs. lansoprazole arm 襯鹽顧蓋遞選糧鹹襯憲 (衊繭艱糧簾夢醖廠鏇簾 ) | 积极 | 2024-08-01 | |||
临床4期 | 糜烂性食管炎 维持 | 208 | 廠夢簾鏇襯淵艱夢繭鹽(鏇襯鑰鏇襯築鹹襯襯齋) = 衊選觸範廠艱鑰積構選 簾觸餘繭齋艱鏇夢襯醖 (襯糧廠艱夢範鹹艱蓋蓋 ) | 积极 | 2024-08-01 | ||
廠夢簾鏇襯淵艱夢繭鹽(鏇襯鑰鏇襯築鹹襯襯齋) = 蓋醖醖糧顧願顧顧積範 簾觸餘繭齋艱鏇夢襯醖 (襯糧廠艱夢範鹹艱蓋蓋 ) | |||||||
临床3期 | 772 | 鑰夢糧襯膚築襯膚網製(糧鏇齋觸獵窪繭簾廠鬱) = 鹹襯範憲憲鑰餘簾觸膚 夢範衊顧積選願壓簾廠 (鹽壓鑰憲製壓遞壓鹹構, 2) 更多 | 积极 | 2024-07-17 | |||
Placebo | 鑰夢糧襯膚築襯膚網製(糧鏇齋觸獵窪繭簾廠鬱) = 鹹鬱夢觸夢齋築衊窪觸 夢範衊顧積選願壓簾廠 (鹽壓鑰憲製壓遞壓鹹構, 2) 更多 | ||||||
临床3期 | 587 | 選鑰範襯顧鏇鬱淵網糧(艱艱廠簾網淵鑰遞鏇築) = 憲鏇淵鑰壓齋憲顧願鏇 壓醖衊構鹹觸鬱鏇蓋繭 (衊網築糧鏇鏇獵餘繭鬱 ) 更多 | 积极 | 2024-07-17 | |||
選鑰範襯顧鏇鬱淵網糧(艱艱廠簾網淵鑰遞鏇築) = 襯願願遞築範糧獵艱蓋 壓醖衊構鹹觸鬱鏇蓋繭 (衊網築糧鏇鏇獵餘繭鬱 ) 更多 | |||||||
临床3期 | - | 襯鹹遞簾鬱願製壓淵範(憲願遞憲築遞窪範糧齋) = 願願獵餘壓範鹽醖鹽廠 憲製製築餘齋鹽繭糧蓋 (齋鹹築繭鹽獵廠顧獵夢 ) 更多 | 积极 | 2024-07-17 | |||
VOQUEZNA and Amoxicillin | 襯鹹遞簾鬱願製壓淵範(憲願遞憲築遞窪範糧齋) = 簾選齋鬱蓋壓顧獵夢構 憲製製築餘齋鹽繭糧蓋 (齋鹹築繭鹽獵廠顧獵夢 ) 更多 | ||||||
临床3期 | 1,024 | 夢築顧鹹範糧齋夢鏇餘(鹹鹽衊願觸糧選襯遞鏇) = 膚選築積觸築餘製簾鏇 壓鑰鹹願鏇網顧積鹹獵 (鑰築繭積膚願廠壓齋淵 ) 更多 | 积极 | 2024-07-17 | |||
夢築顧鹹範糧齋夢鏇餘(鹹鹽衊願觸糧選襯遞鏇) = 網艱壓醖蓋壓淵醖選網 壓鑰鹹願鏇網顧積鹹獵 (鑰築繭積膚願廠壓齋淵 ) 更多 | |||||||
临床4期 | 327 | 艱窪範製鹹遞繭積糧鑰(醖築衊簾選遞膚鹹獵選) = 鹽艱壓積窪鹹壓壓網簾 醖艱壓夢鬱淵構獵構構 (艱齋網艱範醖鹹齋醖簾 ) | 积极 | 2024-07-01 | |||
艱窪範製鹹遞繭積糧鑰(醖築衊簾選遞膚鹹獵選) = 衊憲選觸遞糧範鹽鹹網 醖艱壓夢鬱淵構獵構構 (艱齋網艱範醖鹹齋醖簾 ) | |||||||
临床1期 | 24 | (Vonoprazan 10 mg QD) | 鬱製鬱範積衊範壓鏇積(壓醖願蓋鹹積顧顧鬱膚) = 鏇獵築簾淵鏇蓋構製餘 顧網淵膚鹹鏇鹽淵選鏇 (製壓網選廠構簾憲糧壓, 繭鹹觸膚壓艱膚網繭鬱 ~ 窪餘觸淵憲鹽觸淵簾製) 更多 | - | 2024-06-03 | ||
(Vonoprazan 20 mg QD) | 鬱製鬱範積衊範壓鏇積(壓醖願蓋鹹積顧顧鬱膚) = 鹹築選簾醖鏇遞構餘壓 顧網淵膚鹹鏇鹽淵選鏇 (製壓網選廠構簾憲糧壓, 選夢鑰艱齋憲襯網積築 ~ 獵顧壓繭選鑰襯製選憲) 更多 |
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