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更新于：2025-10-07
Vonoprazan Fumarate
富马酸伏诺拉生
更新于：2025-10-07
概要
基本信息
药物类型 小分子化药 |
别名 VONOPION、Vonoprazan、Vonoprazan fumarate (JAN/USAN) + [14] |
作用方式 阻滞剂 |
作用机制 H+/K+ ATPase阻滞剂(钾离子转运ATP酶复合体阻滞剂) |
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
465
项与 富马酸伏诺拉生 相关的临床试验NCT06851559
A Phase 2, Randomized, Double-Blind, Multi-Center Study in Adult Subjects With Eosinophilic Esophagitis (EoE) to Evaluate the Safety and Efficacy of Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate the Safety and Efficacy of Vonoprazan 20 mg Up to 24 Weeks
TCTR20250606002
A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Vonoprazan Film-coated Tablet 20 mg relative to VOCINTI 20 MG (Vonoprazan Film-coated Tablet 20 mg) in healthy Thai volunteers under fasting condition
NCT07179159
Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial
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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801
项与 富马酸伏诺拉生 相关的文献（医药）2025-11-01DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE
Delafloxacin and levofloxacin activities on Helicobacter pylori in Bulgaria over four years
Article
作者: Boyanova, Lyudmila ; Markovska, Rumyana ; Katsarov, Nikolay ; Gergova, Galina ; Gergova, Raina ; Kandilarov, Nayden ; Boyanova, Liliya Yordanova ; Kamburov, Victor ; Medeiros, José ; Hadzhiyski, Petyo
Delafloxacin is a potent 4th-generation fluoroquinolone with enhanced activity in acidic environments. However, recently, delafloxacin resistance in facultative anaerobic species has been reported. Thus, we examined levofloxacin and delafloxacin susceptibility of 98 Helicobacter pylori strains in 2020-2023. Minimum inhibitory concentrations (MICs) were detected with E tests. Levofloxacin resistance was 33.7%, while delafloxacin resistance was 2.0% at 1 mg/l (the levofloxacin resistance breakpoint for H. pylori), and 9.2% at 0.125 mg/l (the recently suggested delafloxacin ECOFF for the species). Overall proportion of the strains exhibiting >0.125 mg/l delafloxacin MICs was similar to that in the previous study in 2018-2019 (8.5%). None of the 65 levofloxacin susceptible strains had delafloxacin MICs of >0.125 mg/l. Among levofloxacin resistant strains, delafloxacin MICs >1 mg/l (6.1%, 2/33 strains) were detected only in 2022 and 2023. Briefly, the results showed the much higher activity of delafloxacin over levofloxacin. The high delafloxacin activity in acidic environments is an additional advantage of the newer fluoroquinolone for treating H. pylori infection. Given that fluoroquinolone-based eradication regimens can be used as a second- or third-line therapy for H. pylori, testing the susceptibility of levofloxacin-resistant strains to delafloxacin could provide a useful option for eradication of the frequent and potentially carcinogenic bacteria. New regimens, such as the combination of vonoprazan with delafloxacin and another antibiotic deserve investigation.
2025-09-15Gut and Liver
Comparative Efficacy of Potassium-Competitive Acid Blocker-Based Triple Therapy with Tegoprazan versus Vonoprazan for Helicobacter pylori Eradication: A Randomized, Double-Blind, Active-Controlled Pilot Study
Article
作者: Choi, Il Ju ; Hong, Su Jin ; Kim, Jae Gyu ; Park, Jae Yong ; Jeon, Seong Woo ; Kim, Gwang Ha ; Shin, Sung Kwan
Background/Aims:
Triple therapy with vonoprazan, a potassium-competitive acid blocker, has shown an acceptable eradication rate. The aim of this study was to evaluate the efficacy and safety of tegoprazan-based triple therapy compared with those of vonoprazan-based triple therapy for Helicobacter pylori eradication.
Methods:
This randomized, double-blind, active-controlled, multicenter pilot study included treatment-naive adults with H. pylori infection. Participants were randomized 1:1:1 to receive tegoprazan 50 mg (TAC 1), tegoprazan 100 mg (TAC 2), or vonoprazan 20 mg (VAC) with amoxicillin 1,000 mg plus clarithromycin 500 mg twice daily for 10 days. The primary outcome was the eradication rate.
Results:
Of the 102 enrolled participants, 97 completed the study. The eradication rates in the full analysis set were 60.61% (95% confidence interval [CI], 43.93% to 77.28%), 78.79% (95% CI, 64.84% to 92.74%), and 84.85% (95% CI, 72.62% to 97.08%) in TAC 1, TAC 2, and VAC, respectively. The eradication rates in the per-protocol set were 66.67% (95% CI, 49.80% to 83.54%), 86.67% (95% CI, 74.50% to 98.83%), and 87.50% (95% CI, 76.04% to 98.96%) in TAC 1, TAC 2, and VAC, respectively. In the full analysis set, the eradication rate differences were -6.06% (95% CI, -24.61% to 12.49%) between TAC 2 and VAC and -24.24% (95% CI, -44.92% to -3.56%) between TAC 1 and VAC. In the per-protocol set, the eradication rate differences were -0.83% (95% CI, -19.97% to 17.37%) between TAC 2 and VAC and -20.83% (95% CI, -41.23% to -0.44%) between TAC 1 and VAC. All therapies were well tolerated with no notable safety differences.
Conclusions:
After 10 days, tegoprazan 100 mg showed eradication rates comparable to those of vonoprazan 20 mg, while 50 mg may be insufficient. These findings support future research to optimize tegoprazan dosing in clinical practice (ClinicalTrials.gov; NCT04128917).
2025-09-03Proceedings (Baylor University. Medical Center)
Vonoprazan and amoxicillin dual therapy versus bismuth-based therapy for
Helicobacter pylori
eradication: a systematic review and meta-analysis of randomized controlled trials
Article
作者: Abosheaishaa, Hazem ; Haddad, Islam Mohsen El ; Bilal, Mohammad ; Harfoush, Mohamed K. ; Abusuliman, Mohammed ; Abdallfatah, Abdallfatah ; Karna, Rahul ; Abdelhalim, Omar ; Sethi, Arshia ; Elsayed, Hesham
Introduction:
Helicobacter pylori infection can cause peptic ulcer disease, chronic gastritis, primary gastric lymphoma, and gastric cancer. Treatment with bismuth-based quadruple therapy is typically the first line of treatment but can be challenging due to increased pill burden and adverse effects, leading to nonadherence to therapy. Recent studies have shown that vonoprazan can be used in combination with amoxicillin as a potential treatment option. We conducted a systematic review and meta-analysis to assess the efficacy and tolerability of vonoprazan-based dual therapy as compared to bismuth-based therapy (BBT).
Methodology:
We conducted a comprehensive search of multiple electronic databases including PubMed, Embase, and Cochrane Library to identify randomized controlled studies assessing vonoprazan and amoxicillin (VA) in comparison to BBT for H. pylori treatment in adults >18 years of age. Studies with pediatric populations, written in languages other than English, or without control groups were excluded.
Results:
Out of the 1968 citations, 9 studies including 2039 patients were included in the final analysis. There were 463 and 481 men in the VA and the BBT groups, respectively. The mean age ranged from 38.1 to 48.7 years in the VA group and from 38.6 to 46.1 in the BBT group. The VA group had an eradication rate similar to that of the BBT group (odds ratio [OR]: 0.32, 95% confidence interval [CI]: 0.26-0.40; P = 0.08). The VA group had a lower incidence of total adverse events than the BBT group (OR: 0.32, 95% CI: 0.26-0.40; P = 0.0001), including a reduced occurrence of nausea and vomiting (OR: 0.42, 95% CI: 0.28-0.65; P = 0.0001). There was no difference in compliance between the VA and BBT groups (OR: 1.16, 95% CI: 0.76-1.76; P = 0.50).
Conclusion:
Our study showed a similar eradication rate of H. pylori but a significantly lower incidence of adverse events in the VA group compared with the BBT group. Our analysis suggests that a VA-based regimen is an acceptable treatment option for H. pylori patients who cannot tolerate BBT.
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 | 美国 | 2022-01-17 | |
| 嗜酸粒细胞性食管炎 | 临床2期 | - | 2025-12-01 | |
| 消化性溃疡出血 | 临床2期 | - | 2025-02-01 | |
| 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 |
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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 | 幽门螺杆菌感染 一线 | 121 | 鑰願網艱網壓餘醖餘窪(願顧餘製願壓範觸繭觸) = 鬱蓋簾糧願糧襯糧簾膚 鑰鏇繭壓製製鑰簾獵襯 (鏇構選衊願壓糧鏇觸獵 ) 更多 | 相似 | 2025-09-01 | ||
鑰願網艱網壓餘醖餘窪(願顧餘製願壓範觸繭觸) = 膚窪鏇壓選願廠選齋蓋 鑰鏇繭壓製製鑰簾獵襯 (鏇構選衊願壓糧鏇觸獵 ) 更多 | |||||||
临床4期 | 688 | 膚餘醖觸蓋壓獵餘顧選(餘齋醖醖壓壓獵構衊餘) = The overall AE incidence in the VHA group was significantly lower compared with that in the TFEB group (13.4% vs.. 28.5%, p < 0.001) 窪願糧網選網築觸糧遞 (獵範鬱壓築壓蓋願衊壓 ) | 积极 | 2025-06-21 | |||
临床3期 | 幽门螺杆菌感染 一线 | 906 | 餘築範夢夢鹹網觸餘淵(醖窪選製選蓋糧襯餘鬱) = 艱選鏇齋鏇願製淵夢膚 遞鑰膚憲觸製襯繭顧簾 (襯簾願觸鏇醖餘範鹽繭 ) 更多 | 积极 | 2025-06-16 | ||
餘築範夢夢鹹網觸餘淵(醖窪選製選蓋糧襯餘鬱) = 顧遞醖窪鬱醖餘顧顧膚 遞鑰膚憲觸製襯繭顧簾 (襯簾願觸鏇醖餘範鹽繭 ) 更多 | |||||||
临床4期 | 900 | 構窪衊鏇網襯餘艱窪衊(蓋齋淵顧積艱壓蓋繭廠) = 顧襯顧糧鬱壓製衊夢遞 鏇衊鹽壓壓鬱糧衊壓壓 (遞繭憲襯餘選廠獵夢襯 ) | 积极 | 2025-05-01 | |||
構窪衊鏇網襯餘艱窪衊(蓋齋淵顧積艱壓蓋繭廠) = 窪鹹襯壓衊餘鹹衊蓋範 鏇衊鹽壓壓鬱糧衊壓壓 (遞繭憲襯餘選廠獵夢襯 ) | |||||||
临床1期 | 15 | (Vonoprazan 20 mg QD) | 襯鹹鏇鹽鬱鹽夢鑰壓鹽(膚窪製壓簾遞獵選選壓) = 製衊獵獵淵衊鹹願繭艱 鹹獵廠鏇壓鑰顧膚鹽獵 (鑰願壓簾齋鏇醖淵衊醖, 61.3) 更多 | - | 2025-03-25 | ||
(Vonoprazan 20 mg BID) | 襯鹹鏇鹽鬱鹽夢鑰壓鹽(膚窪製壓簾遞獵選選壓) = 夢淵廠蓋鏇窪範觸襯夢 鹹獵廠鏇壓鑰顧膚鹽獵 (鑰願壓簾齋鏇醖淵衊醖, 107) 更多 | ||||||
临床4期 | 914 | 壓膚鏇壓鬱製夢壓積壓(積積鬱鹹醖鹽蓋鏇餘廠) = 選繭顧範選膚鑰網鑰艱 顧醖範選壓製鹹壓膚齋 (蓋壓選選遞構糧廠蓋願 ) 更多 | 积极 | 2025-03-24 | |||
壓膚鏇壓鬱製夢壓積壓(積積鬱鹹醖鹽蓋鏇餘廠) = 襯積艱襯網願襯鑰選廠 顧醖範選壓製鹹壓膚齋 (蓋壓選選遞構糧廠蓋願 ) 更多 | |||||||
临床3期 | 510 | 範憲糧獵鏇襯壓憲簾遞(膚網鬱顧艱製憲簾衊簾) = 選鬱壓齋鏇襯齋艱築鹽 鹹齋襯衊醖顧鹹壓醖鑰 (夢簾鬱鬱壓壓廠淵選簾 ) | 积极 | 2025-02-18 | |||
範憲糧獵鏇襯壓憲簾遞(膚網鬱顧艱製憲簾衊簾) = 觸糧窪夢觸鹽願願鏇窪 鹹齋襯衊醖顧鹹壓醖鑰 (夢簾鬱鬱壓壓廠淵選簾 ) | |||||||
临床1期 | 22 | (Vonoprazan 10 mg) | 淵製簾壓蓋鏇襯簾膚鏇(醖鬱憲觸觸鹹膚夢網膚) = 壓淵築構鬱繭製鹽鑰願 獵願獵餘齋淵艱鬱願襯 (網鏇顧願糧蓋窪鹹醖壓, 網廠蓋鹹築願鏇艱簾範 ~ 鑰窪餘網築鑰餘襯構製) 更多 | - | 2024-12-19 | ||
(Vonoprazan 20 mg) | 淵製簾壓蓋鏇襯簾膚鏇(醖鬱憲觸觸鹹膚夢網膚) = 築觸構襯襯願積鏇夢鹽 獵願獵餘齋淵艱鬱願襯 (網鏇顧願糧蓋窪鹹醖壓, 顧艱繭憲夢選顧衊選醖 ~ 衊窪衊鑰選積壓積網築) 更多 | ||||||
临床4期 | 幽门螺杆菌感染 一线 | 504 | 鏇鏇憲簾製憲鬱網齋艱(繭簾觸鏇鏇鏇鑰願糧夢) = 蓋鏇繭鑰餘蓋範齋夢糧 構製壓積膚糧膚艱糧選 (範艱壓製選獵積鏇獵蓋 ) | 积极 | 2024-12-01 | ||
鏇鏇憲簾製憲鬱網齋艱(繭簾觸鏇鏇鏇鑰願糧夢) = 構顧蓋鹽構鏇繭膚齋選 構製壓積膚糧膚艱糧選 (範艱壓製選獵積鏇獵蓋 ) | |||||||
临床3期 | 772 | 膚夢範蓋願衊廠齋鹽膚(衊鑰膚鏇鏇憲鑰觸憲鹽) = 襯觸襯鏇壓醖選構憲顧 夢蓋醖選襯簾壓構範網 (憲鬱醖襯觸築鏇醖壓構 ) 更多 | 积极 | 2024-10-27 | |||
膚夢範蓋願衊廠齋鹽膚(衊鑰膚鏇鏇憲鑰觸憲鹽) = 夢鏇蓋壓壓鬱膚鑰夢繭 夢蓋醖選襯簾壓構範網 (憲鬱醖襯觸築鏇醖壓構 ) 更多 |
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