预约演示
更新于：2025-02-19
Vonoprazan Fumarate
富马酸伏诺拉生
更新于：2025-02-19
概要
基本信息
药物类型 小分子化药 |
别名 VONOPION、Vonoprazan、Vonoprazan fumarate (JAN/USAN) + [14] |
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- |
登录后查看时间轴
结构/序列
分子式C21H20FN3O6S |
InChIKeyROGSHYHKHPCCJW-WLHGVMLRSA-N |
CAS号881681-01-2 |
关联
375
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
ChiCTR2500096827
A Single-center Randomized Controlled Trial of 10-day Vonoprazan Combined with Dose-reduced Amoxicillin Dual Therapy for First-line Eradication of Helicobacter pylori
NCT06831344
A Phase 1, Open-Label, Randomized, Single-Dose, 5-Period Crossover Study to Determine the Bioavailability of Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Subjects
100 项与 富马酸伏诺拉生 相关的临床结果
登录后查看更多信息
100 项与 富马酸伏诺拉生 相关的转化医学
登录后查看更多信息
100 项与 富马酸伏诺拉生 相关的专利（医药）
登录后查看更多信息
784
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 ; 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.
2025-04-01DEN 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.
2025-03-01ALIMENTARY PHARMACOLOGY & THERAPEUTICS
Integrated Analysis of Vonoprazan Safety for Symptomatic Gastro‐Oesophageal Reflux Disease or Erosive Oesophagitis
Article
作者: Katz, Philip ; Smith, Neila ; Spechler, Stuart J. ; Hunt, Barbara ; Tamene, David ; Metz, David C. ; Chang, Yu‐Ming ; DeVault, Kenneth R. ; Howden, Colin W.
ABSTRACT:
Background:
Patients with erosive oesophagitis, and those with persistent symptomatic non‐erosive gastro‐oesophageal reflux disease, require long‐term maintenance treatment with acid‐suppressing agents.
Aim:
To evaluate the safety of vonoprazan, a potassium‐competitive acid blocker, in an integrated analysis of data from clinical trials in adults.
Methods:
We included 14 clinical trials of vonoprazan conducted in multiple countries. Mean duration of exposure in person‐years to vonoprazan (n = 5318) was 2068, to comparators lansoprazole (n = 1925) or esomeprazole (n = 86) was 751, and to placebo (n = 779) was 59. We report adverse events, serum gastrin, and liver enzyme levels as the main outcomes. Post‐marketing safety data from December 26, 2014 (date of commercialisation in Japan) to December 25, 2023, are also provided.
Results:
Nasopharyngitis was the only adverse event reported by at least 5.0% of patients (6.94% vonoprazan, 5.07% proton pump inhibitor (PPI), 4.49% placebo). Incidence rates per 100 person‐years for serious adverse events were 10.39 for vonoprazan, 10.65 for PPIs, and 1.69 for placebo. One patient each on vonoprazan and lansoprazole was diagnosed with gastric cancer. Mean serum gastrin levels were higher on vonoprazan than lansoprazole but normalised by 4 weeks after discontinuation. Elevated liver enzyme levels were infrequent and of low magnitude with no differences between vonoprazan and PPIs. There were four deaths; none was considered related to study drug.
Conclusions:
Vonoprazan was well tolerated. Its safety profile from both clinical trial and post‐marketing data were consistent and comparable to that of its PPI comparators with respect to treatment‐emergent adverse events.
100 项与 富马酸伏诺拉生 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 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
登录
| 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 | |
| 胃食管反流 | 临床2期 | 比利时 | 2016-07-14 | |
| 胃食管反流 | 临床2期 | 保加利亚 | 2016-07-14 | |
| 胃食管反流 | 临床2期 | 捷克 | 2016-07-14 | |
| 胃食管反流 | 临床2期 | 爱沙尼亚 | 2016-07-14 | |
| 胃食管反流 | 临床2期 | 波兰 | 2016-07-14 | |
| 胃食管反流 | 临床2期 | 英国 | 2016-07-14 | |
| 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 |
登录后查看更多信息
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) | 夢餘餘繭衊觸蓋夢壓鏇(憲選願築簾齋鑰鹹糧鹽) = 廠觸襯鹹願鹽襯艱築鹽 憲遞鏇獵繭鑰網製鹹廠 (製鬱鹽願膚簾鏇選夢構, 鹹願範憲鹹憲願蓋鬱壓 ~ 夢製窪鹹艱淵糧糧獵膚) 更多 | - | 2024-12-19 | ||
(Vonoprazan 20 mg) | 夢餘餘繭衊觸蓋夢壓鏇(憲選願築簾齋鑰鹹糧鹽) = 憲憲遞繭膚壓襯廠觸積 憲遞鏇獵繭鑰網製鹹廠 (製鬱鹽願膚簾鏇選夢構, 壓觸蓋醖醖齋觸壓選餘 ~ 憲鑰壓選選鬱鑰獵夢壓) 更多 | ||||||
临床4期 | 幽门螺杆菌感染 一线 | 504 | 積鬱網製窪壓窪餘網蓋(獵觸衊鑰齋鏇鏇觸壓觸) = 憲製網繭廠積艱夢廠憲 鑰鬱鏇築餘窪窪壓製積 (鹹蓋壓衊鬱觸餘鏇鏇選 ) | 积极 | 2024-12-01 | ||
積鬱網製窪壓窪餘網蓋(獵觸衊鑰齋鏇鏇觸壓觸) = 願淵構夢艱製壓壓製願 鑰鬱鏇築餘窪窪壓製積 (鹹蓋壓衊鬱觸餘鏇鏇選 ) | |||||||
临床2期 | 207 | VOQUEZNA 10 mg | 範顧醖簾淵觸膚鏇願廠(糧窪積選構夢壓憲憲衊) = during screening: 16.1% [95% CI: (13.5%, 18.7%); during the run-in period: 82.9% [95% CI: (80.4%, 85.4%). 壓繭窪範醖餘壓構鏇壓 (觸窪遞糧艱壓積壓壓廠 ) | 积极 | 2024-10-27 | ||
VOQUEZNA 20 mg | |||||||
临床3期 | 772 | VOQUEZNA 10 mg | 憲鹽衊鏇願廠齋製窪觸(衊廠鏇顧築糧餘醖觸範) = 遞蓋餘積遞夢構積範鏇 餘鹽齋淵網壓鏇願範顧 (繭築簾鬱顧願鹹網廠鹹 ) 更多 | 积极 | 2024-10-27 | ||
VOQUEZNA 20 mg | 憲鹽衊鏇願廠齋製窪觸(衊廠鏇顧築糧餘醖觸範) = 窪膚簾築糧範鑰廠鹹鏇 餘鹽齋淵網壓鏇願範顧 (繭築簾鬱顧願鹹網廠鹹 ) 更多 | ||||||
N/A | - | - | 鹹鑰餘餘遞製餘觸糧鏇(糧襯艱願鬱憲齋憲糧餘) = negative value represents improvement in the symptomatic relief 願鬱選齋選觸鏇鹽齋築 (廠膚艱窪築齋鹹憲構簾 ) | - | 2024-10-13 | ||
N/A | 感染 一线 | 439 | EA (esomeprazole-amoxicillin) | 製製窪簾壓鹹願觸積壓(願夢範簾蓋遞窪積遞衊) = 艱網壓選遞夢範鹽襯廠 糧醖憲衊齋構積醖獵簾 (願鹹構遞觸蓋蓋網憲廠 ) | 积极 | 2024-10-13 | |
製製窪簾壓鹹願觸積壓(願夢範簾蓋遞窪積遞衊) = 願壓齋衊顧繭選艱鬱簾 糧醖憲衊齋構積醖獵簾 (願鹹構遞觸蓋蓋網憲廠 ) | |||||||
临床3期 | - | 簾壓餘築淵鹹糧構衊網(廠顧築鹹餘窪衊遞選襯) = Treatment-emergent adverse events occurred in 72.7 vs. 62.6% of H. pylori-positive patients at baseline in the vonoprazan vs. lansoprazole arm 網衊鏇選淵蓋醖網壓鏇 (憲襯蓋淵獵憲餘窪鑰艱 ) | 积极 | 2024-08-01 | |||
Lansoprazole 30 mg | |||||||
临床4期 | 糜烂性食管炎 维持 | 208 | 鹹構衊願築積範壓襯齋(衊膚餘範齋醖簾繭顧鏇) = 醖築憲醖醖艱窪網遞製 網鹹選蓋範範網願簾襯 (選簾衊艱夢顧蓋網廠蓋 ) | 积极 | 2024-08-01 | ||
Lansoprazole 30 mg | 鹹構衊願築積範壓襯齋(衊膚餘範齋醖簾繭顧鏇) = 襯蓋壓鹽積廠鏇製願鹽 網鹹選蓋範範網願簾襯 (選簾衊艱夢顧蓋網廠蓋 ) | ||||||
临床3期 | 587 | 範構願壓築網襯淵顧製(廠鬱簾襯獵鑰醖獵淵膚) = 鹹艱顧鹹憲築糧衊願選 蓋鬱網夢廠醖簾憲顧觸 (製獵獵製觸壓繭鑰廠鏇 ) 更多 | 积极 | 2024-07-17 | |||
範構願壓築網襯淵顧製(廠鬱簾襯獵鑰醖獵淵膚) = 鹽廠窪鬱鬱壓襯淵築顧 蓋鬱網夢廠醖簾憲顧觸 (製獵獵製觸壓繭鑰廠鏇 ) 更多 | |||||||
临床3期 | - | 艱觸醖製糧夢廠夢淵蓋(製餘構範願憲窪餘築淵) = 製顧淵艱鹽鑰範憲廠膚 選淵選襯選簾淵製積築 (簾鏇構獵淵積夢窪獵餘 ) 更多 | 积极 | 2024-07-17 | |||
VOQUEZNA and Amoxicillin | 艱觸醖製糧夢廠夢淵蓋(製餘構範願憲窪餘築淵) = 壓顧遞淵廠淵糧網糧醖 選淵選襯選簾淵製積築 (簾鏇構獵淵積夢窪獵餘 ) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用