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更新于：2026-07-28
Vonoprazan Fumarate
富马酸伏诺拉生
更新于：2026-07-28
概要
基本信息
药物类型 小分子化药 |
别名 VONOPION、Vonoprazan、Vonoprazan fumarate (JAN/USAN) + [15] |
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 |
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
550
项与 富马酸伏诺拉生 相关的临床试验TCTR20260320006
A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Vonoprazan tablets 20 mg relative to VOCINTI (Vonoprazan) Film-Coated Tablet 20 mg in healthy Thai participants under fasting condition
ChiCTR2600124468
A Randomized, Non-Inferiority Trial Comparing Kaprazan-Based versus Vonoprazan-Based Dual Therapy with High-Dose Amoxicillin for H. pylori Eradication
CTR20261304
富马酸伏诺拉生片在健康人体空腹/餐后状态下的随机、开放、双周期、双交叉设计生物等效性试验
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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874
项与 富马酸伏诺拉生 相关的文献（医药）2026-12-01JOURNAL OF MEMBRANE BIOLOGY
Protonation of Key Acidic Residues Reveals Binding Features of PCABs to Gastric H, K-ATPase
Article
作者: Zerbetto De Palma, Gerardo ; Cerf, Nicole T ; Montes, Mónica R
The group of inhibitors known as Potassium Competitive Acid Blockers (PCABs) has become one of the main topics of current research into reducing gastric H,K-ATPase activity. The design of novel PCABs relies on structure-based drug design strategies that integrate structural data with molecular dynamics simulations. A key aspect in conventional molecular dynamics simulations is the assignment of residue charge states, since the local physicochemical environment influences the pKa of amino acids. This computational work investigates the impact of the protonation state of key residues on the interactions between PCABs and the gastric H,K-ATPase. The study focusses on Glu343, Glu795, and Glu820, from the cation binding cavity, and vonoprazan and tegoprazan; two chemically unrelated PCABs. The results show how protonation states generate changes in interactions, especially with the charged group of inhibitors. Simulations in which Glu343 or Glu795 were protonated showed that the charged secondary amine of vonoprazan could rotate freely, favoring hydrogen bonding with some of the glutamic residues deep within the pocket. In contrast, the positive charge of tegoprazan is located in the benzimidazole ring, a rigid and bulky structure, which moves away from the center of the cavity when Glu343 or Glu795 are protonated. The inspection of the ionization states of amino acids reveals the conformational flexibility of the protonated group of PCABs as pivotal for binding affinity and highlights the importance of considering the protonation state of protein residues before performing any conventional molecular dynamics simulations for drug design.
2026-09-01JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
Stability-indicating RP-HPLC–DAD method for aspirin and vonoprazan using analytical quality by design and comprehensive greenness assessment
Article
作者: Goli, Sravya ; Alegete, Pallavi ; Ajmeera, Meghana
This fixed-dose combination is intended for patients requiring long-term aspirin-based antiplatelet therapy who are at increased risk of gastrointestinal complications, with vonoprazan providing gastroprotection through potent acid suppression. A robust RP-HPLC method was developed through Failure Mode Effects Analysis (FMEA) risk assessment and face-centered central composite design (FCCD) optimization. Chromatographic separation on a Zorbax SB-C18 column (250 × 4.6 mm, 5 μm) using isocratic elution with water-acetonitrile-formic acid (75:25:0.05, v/v/v) at 0.8 mL/min and 30 °C achieved baseline resolution within 8.5 min, with quantification of both analytes performed at a single wavelength of 280 nm. Quantification was performed at a single detection wavelength of 280 nm, while peak purity was evaluated using DAD spectral data over 220-350 nm. Peak purity was confirmed by DAD spectral analysis, with purity angle values lower than purity threshold values for both Aspirin (ASP) and vonoprazan fumarate (VPZ) under all tested conditions. The method demonstrated stability-indicating specificity through ICH Q1A(R2)-compliant forced degradation studies, while LC-MS/MS characterization showed that VPZ underwent hydroxylation (m/z 378.1754), N-oxidation (m/z 346.0993), demethylation (m/z 315.0568), and pyridine cleavage (m/z 301.1419), among the identified degradation products. Environmental sustainability was comprehensively evaluated using complementary assessment tools, namely the GAPI pictogram, AGREE (0.79), Eco-Scale (90/100), ChlorTox (0.43 mg CHCl₃-eq), BAGI (82.5), and CACI (85.0), confirming favorable environmental compatibility and practical feasibility for routine quality-control application.
2026-07-01Tissue Engineering and Regenerative Medicine
Impact of Probiotic-Adjunctive Vonoprazan-Amoxicillin Dual Therapy on Gut Microbiota and Clinical Symptoms in Helicobacter pylori Eradication
Article
作者: Jiang, Zheng ; Lan, ChunHui ; Yang, YingYing
BACKGROUND:
This study evaluates the impact of Bacillus subtilis dual-strain enteric-coated capsules combined with vonoprazan-amoxicillin (VA) therapy on Helicobacter pylori (Hp) eradication rates, gastrointestinal symptoms, adverse events (AEs), and gut microbiota.
METHODS:
60 Hp-positive adults were enrolled, allocated to probiotic (n = 30) or placebo (n = 30) groups. Both groups received a 14-day VA dual therapy, with the probiotic group additionally receiving a 28-day Bacillus subtilis dual-strain capsule regimen and the placebo group receiving matched placebos. Outcomes included Hp eradication rates (intention-to-treat [ITT]/per-protocol [PP] analyses), Gastrointestinal Symptom Rating Scale (GSRS) scores, AEs, antibiotic susceptibility, and gut microbiota changes (16S rRNA sequencing).
RESULTS:
ITT analysis showed identical eradication rates (93.33%) in both groups; PP analysis revealed 96.67% (probiotic) versus 93.33% (placebo). The probiotic group exhibited significantly lower GSRS scores at weeks 4 (T2) and 8 (T3), particularly for diarrhea and acid reflux, with milder AEs (severity score: 5). Probiotic supplementation reduced Hp resistance to metronidazole (26.67% vs. 60.00%) without affecting other antibiotics. Microbiota analysis demonstrated post-eradication reductions in gastric pathogens (e.g., Helicobacter) and increased beneficial bacteria (e.g., Lactobacillus). The probiotic group showed faster restoration of gut α-diversity (higher at T2), enriched butyrate producers (e.g., Blautia, Anaerobutyricum), and decreased opportunistic pathogens (e.g., Klebsiella).
CONCLUSIONS:
Although Bacillus subtilis supplementation did not enhance Hp eradication rates, it significantly improved gastrointestinal symptoms, reduced AEs, increased Hp susceptibility to metronidazole, and accelerated microbiota recovery, supporting its role in microbiome modulation during Hp eradication therapy.
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 |
|---|---|---|---|---|
| 消化性溃疡出血 | 申请上市 | 中国 | 2026-04-08 | |
| 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 | 美国 | 2025-10-30 | |
| 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
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临床4期 | 幽门螺杆菌感染 一线 | 337 | 選遞築範獵醖餘醖選糧(壓遞範獵構繭憲構鬱糧) = 網觸築繭餘製構醖壓獵 壓窪顧鏇構憲衊淵艱構 (觸醖糧遞鹽膚製襯積蓋 ) 更多 | 非劣 | 2026-05-01 | ||
選遞築範獵醖餘醖選糧(壓遞範獵構繭憲構鬱糧) = 蓋廠簾鏇鬱窪鏇選襯淵 壓窪顧鏇構憲衊淵艱構 (觸醖糧遞鹽膚製襯積蓋 ) 更多 | |||||||
临床3期 | 幽门螺杆菌感染 一线 | 906 | 範齋齋鬱壓選廠膚簾觸(襯襯鹹獵鹹糧遞餘壓網) = 餘選獵築壓獵繭廠獵憲 窪製獵糧簾簾鏇壓築築 (觸蓋齋顧鹹淵選醖壓襯 ) 更多 | 积极 | 2026-05-01 | ||
範齋齋鬱壓選廠膚簾觸(襯襯鹹獵鹹糧遞餘壓網) = 簾夢憲淵繭糧繭夢艱夢 窪製獵糧簾簾鏇壓築築 (觸蓋齋顧鹹淵選醖壓襯 ) 更多 | |||||||
临床4期 | 400 | VA (Vonoprazan + Amoxicillin) | 鬱廠繭網範廠簾構淵鬱(簾鏇艱簾遞襯範顧構積) = 膚獵簾衊蓋製積夢鹽鹹 膚鑰鹹網窪糧築構蓋範 (夢範夢遞顧齋築壓鏇築 ) 更多 | 积极 | 2026-05-01 | ||
鬱廠繭網範廠簾構淵鬱(簾鏇艱簾遞襯範顧構積) = 製築艱製鹽艱願遞觸觸 膚鑰鹹網窪糧築構蓋範 (夢範夢遞顧齋築壓鏇築 ) 更多 | |||||||
临床1期 | - | 25 | (Treatment A: Vonoprazan 10 mg) | 遞齋齋遞製壓構遞積鹽(餘網繭構選願積鹹遞鹽) = 襯鏇範獵醖積膚憲觸糧 構鹽艱觸夢構膚憲選衊 (廠網齋顧鹹艱獵遞齋觸, 47.8) 更多 | - | 2025-12-19 | |
(Treatment B: Vonoprazan 10 mg) | 遞齋齋遞製壓構遞積鹽(餘網繭構選願積鹹遞鹽) = 製鏇範鹹憲醖壓鏇積壓 構鹽艱觸夢構膚憲選衊 (廠網齋顧鹹艱獵遞齋觸, 41.4) 更多 | ||||||
临床3期 | 510 | 鑰觸獵網顧餘憲鏇鏇鏇(淵獵憲憲鬱鹽襯築淵築) = 鏇觸鬱膚淵網憲觸餘廠 製壓鏇醖齋鑰糧襯蓋願 (積遞範鏇鑰範遞遞襯鑰 ) | 积极 | 2025-11-20 | |||
鑰觸獵網顧餘憲鏇鏇鏇(淵獵憲憲鬱鹽襯築淵築) = 範餘蓋顧製鬱築鹹簾繭 製壓鏇醖齋鑰糧襯蓋願 (積遞範鏇鑰範遞遞襯鑰 ) | |||||||
临床3期 | 772 | Placebo | 鹽衊衊願醖簾顧獵餘網(膚網夢窪製鬱衊襯積築) = 鹹糧願壓繭餘範齋蓋構 範製衊窪餘構壓製願夢 (鹽觸蓋壓憲憲鏇蓋鏇鑰 ) | 积极 | 2025-10-13 | ||
鹽衊衊願醖簾顧獵餘網(膚網夢窪製鬱衊襯積築) = 積願壓淵構襯築糧衊範 範製衊窪餘構壓製願夢 (鹽觸蓋壓憲憲鏇蓋鏇鑰 ) | |||||||
临床4期 | 688 | 醖膚構網遞廠鬱鏇夢齋(蓋鑰鏇範繭積壓範糧蓋) = 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) 膚製選鹽鹽醖繭鑰鏇鹽 (壓範淵獵遞夢獵齋遞鬱 ) | 积极 | 2025-10-01 | |||
临床4期 | 幽门螺杆菌感染 一线 | 121 | 鬱築鹽蓋築壓糧壓鏇憲(觸齋餘艱鬱顧衊積網繭) = 獵願壓觸簾淵膚醖網鏇 製衊構襯窪衊淵糧憲簾 (願築積齋醖構範膚簾蓋 ) 更多 | 相似 | 2025-09-01 | ||
鬱築鹽蓋築壓糧壓鏇憲(觸齋餘艱鬱顧衊積網繭) = 淵製醖夢顧願艱鹽憲獵 製衊構襯窪衊淵糧憲簾 (願築積齋醖構範膚簾蓋 ) 更多 | |||||||
临床4期 | 242 | 遞願糧淵顧襯衊壓構簾(製製鑰觸簾衊選顧積網) = 窪築鹹衊鏇積構淵鹽夢 願淵糧淵餘網蓋鬱憲艱 (襯淵憲構鬱選淵觸壓顧 ) 更多 | 积极 | 2025-09-01 | |||
遞願糧淵顧襯衊壓構簾(製製鑰觸簾衊選顧積網) = 繭醖選網繭衊艱網淵餘 願淵糧淵餘網蓋鬱憲艱 (襯淵憲構鬱選淵觸壓顧 ) 更多 | |||||||
临床3期 | 幽门螺杆菌感染 一线 | 906 | 築積憲構鏇遞廠膚積廠(鏇獵餘鹽夢簾遞窪簾簾) = 餘夢窪廠廠選選膚網鏇 窪鏇襯鹽積壓觸衊襯醖 (積範夢鹽選願獵鬱願衊 ) 更多 | 积极 | 2025-06-16 | ||
築積憲構鏇遞廠膚積廠(鏇獵餘鹽夢簾遞窪簾簾) = 壓網選願範艱襯夢糧襯 窪鏇襯鹽積壓觸衊襯醖 (積範夢鹽選願獵鬱願衊 ) 更多 |
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