富马酸伏诺拉生(Vonoprazan Fumarate) - 药物靶点：H+/K+ ATPase_在研适应症：非糜烂性胃食管反流病，糜烂性食管炎，胃灼热_专利_临床

概要

基本信息

药物类型

小分子化药

别名

VONOPION、Vonoprazan、Vonoprazan fumarate (JAN/USAN)

+ [14]

靶点

H+/K+ ATPase

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)

治疗领域

感染消化系统疾病口颌疾病+ [4]

在研适应症

非糜烂性胃食管反流病糜烂性食管炎胃灼热+ [10]

非在研适应症

非糜烂性反流病

原研机构

Takeda Pharmaceutical Co., Ltd.

在研机构

浙江尖峰药业有限公司

Takeda Pharmaceutical Co., Ltd.

Phathom Pharmaceuticals, Inc.

+ [3]

非在研机构-

权益机构

Takeda Pharmaceutical Co., Ltd.

Phathom Pharmaceuticals, Inc.

Lupin Ltd

+ [3]

最高研发阶段批准上市

首次获批日期

日本 (2014-12-26),

十二指肠溃疡反流性食管炎幽门螺杆菌感染+ [1]

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

461

项与富马酸伏诺拉生相关的临床试验

NCT06851559

/ Not yet recruiting临床2期

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

The primary objective of this study is to assess the efficacy of vonoprazan 20 mg once daily (QD) compared to placebo QD in the number of participants with a peak eosinophilic histologic response <15 eosinophils per high-power field (eos/hpf) after 12 weeks of therapy.

开始日期2025-12-01

申办/合作机构

Phathom Pharmaceuticals, Inc.

TCTR20250606002

/ Not yet recruiting临床1期IIT

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

开始日期2025-09-23

申办/合作机构

Bio-innova Co., Ltd

NCT07179159

/ Not yet recruitingN/AIIT

Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial

This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.

开始日期2025-09-09

申办/合作机构

山东大学

[+4]

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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798

项与富马酸伏诺拉生相关的文献（医药）

2025-11-01·DIAGNOSTIC 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.

2025-09-15·Gut 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).

2025-09-03·Proceedings (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.

423

项与富马酸伏诺拉生相关的新闻（医药）

2025-09-17

·ETPharma

Dr Reddy’s debuts in-licensed acid blocker Tegoprazan in India

Hyderabad: Expanding its gastrointestinal portfolio in India, Dr Reddy’s Laboratories has announced the launch of its in-licensed novel molecule ‘ Tegoprazan ’, under the brand name ‘ Pcab ’ in India. Tegoprazan is a potassium-competitive acid blocker (P-CAB) which blocks H⁺/K⁺-ATPase enzyme , — a protein pomp responsible for the production of gastric acid. The drug is indicated for the treatment of acid peptic diseases (APD) such as Gastric Ulcer, Erosive Gastroesophageal Reflux Disease (GERD) and Non-Erosive Gastroesophageal Reflux Disease (NERD). Unlike the traditional proton pump inhibitors, Tegoprazan induces fast onset of action and can control gastric pH for a prolonged period. “Our partnership with HK inno.N Corporation for Tegoprazan brings together complementary strengths to enhance patient access to an innovative molecule that addresses critical gaps in acid peptic disease management and improves outcomes., “said M.V. Ramana, CEO Branded Markets (India and Emerging Markets), Dr.Reddy’s. Tegoprazan is developed by South Korea-based HK inno.N Corporation and in 2022, the Hyderabad-based drugmaker obtained the drug's India and select emerging markets commercial rights for an undisclosed amount. Currently the drug is approved in 21 countries and further registration in several countries is under process. Besides Tegoprazan, other approved P-CABs include 'Takecab,' marketed by Japanese biopharma company Takeda. However, Dr. Reddy’s formulation will be available in a 50 mg dose, whereas competing products are marketed in 10 mg and 20 mg strengths. According to the company release, APD affects around 38 per cent of the country’s total population. Data from the domestic market sales tracker PharmaTrac suggest that the gastrointestinal therapies represents the second largest drug market in India after cardiac, with a moving annual turnover of (MAT) Rs 28,263 crore as of August this year. By Online Bureau ,

上市批准生物类似药引进/卖出

2025-09-16

·米内网

【重磅】正大天晴拿下大涨140%明星药首仿

精彩内容近日，国家药监局官网显示，正大天晴药业申报的4类仿制药注射用醋酸地加瑞克获批生产，为国内首仿+首家过评，原研产品2025年一季度在中国三大终端六大市场（统计范围详见本文末）的销售额增速超过140%。今年以来，正大天晴药业有6个品种获批生产并视同过评。地加瑞克是一款选择性促性腺激素释放激素受体（GnRHR）拮抗剂，可竞争性和可逆地结合垂体GnRH受体，从而快速减少促性腺激素、促黄体激素（LH）及促卵泡激素（FSH）的释放，并减少睾丸分泌睾酮（T），适用于需要雄激素去势治疗的前列腺癌患者。辉凌医药的注射用醋酸地加瑞克最早于2018年9月获批进入国内市场，目前已被纳入国家医保乙类目录。米内网数据显示，该药近年来在中国三大终端六大市场的销售额呈逐年上涨态势，2025年一季度同比大涨超140%。近年来中国三大终端六大市场注射用醋酸地加瑞克销售情况（单位：万元）来源：米内网格局数据库仿制药方面，正大天晴药业的注射用醋酸地加瑞克于近日获批生产，拿下国内首仿+首家过评，目前暂无其他企业的产品报产在审。值得一提的是，早前，正大天晴药业的注射用醋酸地加瑞克已获得欧洲上市批准及美国暂时批准，并凭借成功的专利挑战，获得中国市场12个月独占期。在抗肿瘤和免疫调节剂领域，正大天晴药业拥有30余个产品的生产批文，其中1类新药盐酸安罗替尼胶囊2024年在中国三大终端六大市场的销售额超过38亿元，达沙替尼片、泊马度胺胶囊、甲磺酸伊马替尼胶囊、氟维司群注射液、甲磺酸仑伐替尼胶囊等首仿药均销售过亿。米内网数据显示，今年以来，正大天晴药业有6个品种获批生产并视同过评，分别为富马酸伏诺拉生片、沙格列汀二甲双胍缓释片(Ⅲ)、沙格列汀二甲双胍缓释片(Ⅰ)、注射用头孢他啶阿维巴坦钠(4:1)、艾地骨化醇软胶囊、注射用醋酸地加瑞克。此外，今年以来，正大天晴药业有6个品种以新注册分类报产，其中酒石酸阿福特罗雾化吸入溶液、盐酸帕洛诺司琼软胶囊、乌美溴铵维兰特罗吸入粉雾剂在国内均暂无仿制药获批，磷酸芦可替尼片获批的国内企业仅有1家。今年以来正大天晴药业以新注册分类报产的品种来源：米内网中国申报进度（MED）数据库注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至9月16日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准一致性评价免疫疗法

2025-09-16

·米内网

飙涨148%！东阳光药大突破，39款1类新药来势汹汹，12款新药上市可期

精彩内容今年以来，东阳光药产品研发持续推进：2款1类新药首次获批上市，2款生物类似药首次提交NDA，3款1类新药首次获批临床等。东阳光药坚持“创新”和“国际化”双引擎驱动，目前公司有57款新药（39款1类新药）在国内处于申请临床及以上阶段，其中有12款新药已提交NDA或处于III期临床（含II/III期），上市可期。大丰收！2款1类新药获批，胰岛素收入大涨 8月7日，东阳光药吸收合并港股上市子公司东阳光长江药业并以介绍方式登陆港交所主板，将自身研发能力与东阳光长江药业的全国销售网络深度整合，形成“研发-生产-销售”闭环，加速全球化运营。 8月29日，东阳光药发布2025年上半年业绩，报告期内取得营业额约19.38亿元。从分领域收入看，抗病毒药物收入14.12亿元，占总收入比重约73%；慢病治疗药物收入4.73亿元，占总收入比重约24%；其他类收入0.53亿元。 2025H1东阳光药各药物类别收入情况（单位：亿元）来源：公司公告，米内网整理从具体产品看，由于流感疫情较去年同期有所放缓，作为流感首选用药的奥司他韦产品受到一定影响，但可威依托深厚的品牌价值与广泛的市场渗透力，依然稳居国内抗流感市场的领军地位；胰岛素系列产品实现营收1.22亿元，同比增长高达148%，彰显东阳光药在慢病治疗领域的增长潜力；1类新药磷酸依米他韦胶囊实现营收42.3百万元，呈现稳健的业绩表现。在创新研发上，今年上半年东阳光药研发支出达3.48亿元，占总收入比重约18%。持续的研发投入为东阳光药长期发展奠定坚实基础，也让公司的创新药管线逐渐迎来兑换期。今年以来，东阳光药有2款1类新药首次在国内获批上市，为磷酸萘坦司韦胶囊、艾考磷布韦片，两者联合用于治疗初始或干扰素经治的基因1、2、3、6型成人丙肝，为国内获批的国产唯一具有自主知识产权的口服泛基因型丙肝治疗方案，进一步巩固公司在丙肝治疗领域的领先地位。 3款1类新药、1款2.2类新药首次在国内获批临床。其中1类新药HEC-007注射液（GLP-1/GIP/GCG三靶点多肽药物）、HEC-301注射液（GDF15激动剂）均适用于治疗超重或肥胖等，且HEC-007注射液已启动I期临床；HEC20002胶囊为改良型新药，用于治疗精神分裂症。今年以来东阳光药获批上市/临床的新药来源：米内网中国申报进度（MED）数据库 2款生物类似药首次在国内提交NDA，为德谷门冬双胰岛素注射液、德谷胰岛素注射液，原研产品2024年在中国三大终端六大市场的销售额（统计范围详见本文末）分别超过14亿元、8亿元；4款1类新药、2款2.2类新药首次在国内提交IND，其中有3款1类新药、1款2.2类新药已获批临床。仿制药方面，舒更葡糖钠注射液获批生产并视同过评，该药近年来在中国三大终端六大市场的销售额呈逐年上涨态势，2024年超过9亿元；艾拉莫德片以新注册分类报产，该药为先声药业国产原研1类新药，目前已有多款仿制药获批，2024年在中国三大终端六大市场的销售额超过17亿元。 39款1类新药蓄力，围攻三大治疗领域截至目前，东阳光药已有3款1类新药获批上市，分别为磷酸依米他韦胶囊、磷酸萘坦司韦胶囊、艾考磷布韦片，均为丙肝治疗药物。今年8月，东阳光药正式成立肝病专线商业化团队，旨在进一步推动其丙肝等创新药的商业化进程，开拓销售峰值可达20亿元的市场。除了已商业化的新药，目前东阳光药还有57款新药（39款1类新药）在国内处于申请临床及以上阶段，集中在消化及代谢系统、抗肿瘤和免疫调节剂、全身用抗感染、神经系统等治疗领域。东阳光药国内处于申请临床及以上阶段的新药来源：米内网综合数据库消化及代谢领域涵盖糖尿病、肥胖、非酒精性脂肪性肝炎等细分病种，其中1类新药焦谷氨酸荣格列净胶囊（SGLT2抑制剂）、生物类似药德谷胰岛素注射液及德谷门冬双胰岛素注射液分别于2024年1月、2025年2月、2025年6月提交NDA；此外，HEC96719片、HEC88473注射液处于II期临床，HEC-007注射液步入I期临床，目前国内尚无FXR激动剂、GLP-1/FGF21双靶点长效融合蛋白、GLP-1/GCG/GIP三靶点多肽获批上市，东阳光药研发进度靠前。在抗肿瘤和免疫调节剂领域，研发进展较快的主要为小分子抑制剂，其中苯磺酸克立福替尼片作为第二代高选择性FLT3抑制剂，正在国内开展用于治疗复发或难治的携带FLT3-ITD突变的急性髓系白血病的III期临床，目前已进入快速入组阶段；临床前早期研发管线具有FIC或BIC的潜力，如全球首创针对结直肠癌的4-1BB/LY6G6D双抗HEC-921、口服且高活性的Pan KRAS抑制剂HEC211909等。全身用抗感染领域聚焦流感、乙肝、丙肝等，其中甲磺酸莫非赛定胶囊（靶向HBV核衣壳蛋白装配抑制剂）处于III期临床；已提交IND的HECN30227注射液是东阳光药基于其小核酸技术平台开发的首款siRNA药物，该新药可同时消除cccDNA和intDNA来源的HBsAg，有望为乙肝治疗领域带来范式转变，同时也标志着公司在小核酸药物研发领域迈出关键一步。仿制药申报方面，目前东阳光药有5个品种以新注册分类报产在审，分别为艾拉莫德片、富马酸伏诺拉生片、米拉贝隆缓释片、西格列汀二甲双胍缓释片、盐酸芬戈莫德胶囊。其中，艾拉莫德片、富马酸伏诺拉生片2024年在中国三大终端六大市场的销售额分别超过17亿元、8亿元；盐酸芬戈莫德胶囊暂无首仿获批，东阳光药首家以新注册分类报产。东阳光药以新注册分类报产在审的品种来源：米内网中国申报进度（MED）数据库仿制药、胰岛素、创新药......国际化布局加速在海外市场，东阳光药已建立起覆盖主流国际市场的全球销售网络，海外销售网络已覆盖包括美国、德国及英国在内八个国家及地区。 2025年上半年，东阳光药有2款仿制药获得欧美药品注册批件，分别为利伐沙班片美国药品注册批件和奥司他韦干混悬剂德国药品注册批件。米内网数据显示，目前东阳光药获得FDA批准的ANDA文号已接近40个，涉及30余个品种。除了仿制药，东阳光药的生物类似药甘精胰岛素注射液已递交美国生物制品许可申请(BLA)，成为中国仅有的两家针对美国市场开发甘精胰岛素注射液并成功递交BLA的制药企业之一，有望于2026年上半年获得BLA批准。此外，东阳光药还向FDA递交门冬胰岛素注射液的临床申请前(Pre-IND)的咨询。创新药方面，2024年11月，东阳光药与Apollo Therapeutics达成授权许可协议，以最高9.38亿美元的款项（包括1200万美元的首付款和最高9.26亿美元的开发、监管及商业里程碑付款），将其开发的新型GLP-1/FGF21双靶点长效融合蛋白HEC88473的海外许可及商业化协议授予给Apollo Therapeutics。未来在海外市场拓宽上，东阳光药计划推进以下策略：1、促进现有产品的国际销售，特别是获得欧洲和美国批准的药品；2、在研发、产品注册、临床试验和商业化方面建立国际能力，重点推进具有临床价值和海外市场具有竞争优势的在研药物的临床试验；3、持续加强与跨国药企的交流与合作，提升公司在国际医药市场的地位。资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至9月15日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

生物类似药上市批准财报临床1期临床3期

100 项与富马酸伏诺拉生相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10466	富马酸伏诺拉生	A02BC08	DB11739

研发状态

批准上市

10 条最早获批的记录,

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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	Phathom Pharmaceuticals, Inc.	2024-07-17
糜烂性食管炎	美国	Phathom Pharmaceuticals, Inc.	2023-11-01
胃灼热	美国	Phathom Pharmaceuticals, Inc.	2023-11-01
糜烂性胃食管反流病	韩国	Takeda Pharmaceuticals Korea Co., Ltd.	2019-03-29
十二指肠溃疡	日本	Takeda Pharmaceutical Co., Ltd.	2014-12-26
反流性食管炎	日本	Takeda Pharmaceutical Co., Ltd.	2014-12-26
幽门螺杆菌感染	日本	Takeda Pharmaceutical Co., Ltd.	2014-12-26
胃溃疡	日本	Takeda Pharmaceutical Co., Ltd.	2014-12-26

未上市

10 条进展最快的记录,

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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	Phathom Pharmaceuticals, Inc.	2022-01-17
嗜酸粒细胞性食管炎	临床2期	-	Phathom Pharmaceuticals, Inc.	2025-12-01
消化性溃疡出血	临床2期	-	山东新时代药业有限公司	2025-02-01
胃食管反流	临床2期	比利时	Takeda Pharmaceutical Co., Ltd.	2016-07-14
胃食管反流	临床2期	保加利亚	Takeda Pharmaceutical Co., Ltd.	2016-07-14
胃食管反流	临床2期	捷克	Takeda Pharmaceutical Co., Ltd.	2016-07-14
胃食管反流	临床2期	爱沙尼亚	Takeda Pharmaceutical Co., Ltd.	2016-07-14
胃食管反流	临床2期	波兰	Takeda Pharmaceutical Co., Ltd.	2016-07-14
胃食管反流	临床2期	英国	Takeda Pharmaceutical Co., Ltd.	2016-07-14
消化不良	临床1期	中国	浙江尖峰药业有限公司	2024-05-17

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06168084 (not provided, Pubmed \| United European Gastroenterol J)	临床4期	幽门螺杆菌感染	688	Vonoprazan and High-Dose Amoxicillin (VHA) dual therapy	鹽糧糧衊鬱製廠構壓積(繭構網齋蓋餘醖鹹襯襯) = 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) 選壓艱鏇醖鏇憲積餘醖 (遞艱衊艱鹽網鑰膚糧網 )	积极	2025-06-21
				Tetracycline- and Furazolidone-based Bismuth-Containing Quadruple Therapy (TFEB)
NCT05191888 (Pubmed \| Am J Gastroenterol)	临床3期	幽门螺杆菌感染一线	906	Vonoprazan high-dose dual therapy	鹹衊顧積觸廠糧蓋廠膚(選壓築積蓋鹹繭醖獵襯) = 膚構鑰願襯鏇簾鏇鹹簾襯製築衊觸鏇齋齋鑰繭 (鏇顧廠夢餘觸夢鹹願壓 ) 更多	积极	2025-06-16
				Vonoprazan triple therapy	鹹衊顧積觸廠糧蓋廠膚(選壓築積蓋鹹繭醖獵襯) = 簾獵糧膚餘壓憲選壓艱襯製築衊觸鏇齋齋鑰繭 (鏇顧廠夢餘觸夢鹹願壓 ) 更多
NCT05649540 (Pubmed \| Helicobacter)	临床4期	幽门螺杆菌感染	900	High-dose amoxicillin (HVA)	觸憲遞願衊鏇鬱艱簾網(遞鹹憲窪築網築齋網糧) = 夢繭築鏇網蓋鑰夢艱鑰選鹹艱顧鹹鑰鹹淵糧範 (膚選衊觸膚艱襯餘淵範 )	积极	2025-05-01
				Medium-dose amoxicillin (MVA)	觸憲遞願衊鏇鬱艱簾網(遞鹹憲窪築網築齋網糧) = 顧製壓鏇鹽艱夢願壓觸選鹹艱顧鹹鑰鹹淵糧範 (膚選衊觸膚艱襯餘淵範 )
NCT06391177 (CTgov)	临床1期	糜烂性食管炎 \| 幽门螺杆菌感染 \| 胃食管反流 ... 更多	15	Vonoprazan (Vonoprazan 20 mg QD)	鹹襯夢憲繭簾製構積遞(獵鬱窪膚壓齋淵齋遞鬱) = 餘壓憲鏇選網積願鏇願廠願膚製鬱鑰鬱夢糧襯 (齋醖壓糧齋顧衊選鹹襯, 61.3) 更多	-	2025-03-25
				Vonoprazan (Vonoprazan 20 mg BID)	鹹襯夢憲繭簾製構積遞(獵鬱窪膚壓齋淵齋遞鬱) = 淵鹽築獵艱願蓋夢膚鹹廠願膚製鬱鑰鬱夢糧襯 (齋醖壓糧齋顧衊選鹹襯, 107) 更多
NCT05469685 (Pubmed \| Front Pharmacol)	临床4期	幽门螺杆菌感染	914	10-day vonoprazan-amoxicillin (VA) therapy	艱餘淵鏇鹽憲製獵膚選(襯膚艱夢顧鹹齋遞憲顧) = 選糧餘觸鑰襯淵網製積顧選衊膚顧簾遞齋憲簾 (網觸膚醖齋製壓願簾選 ) 更多	积极	2025-03-24
				14-day vonoprazan-amoxicillin (VA) therapy	艱餘淵鏇鹽憲製獵膚選(襯膚艱夢顧鹹齋遞憲顧) = 願齋築廠築壓顧選齋鬱顧選衊膚顧簾遞齋憲簾 (網觸膚醖齋製壓願簾選 ) 更多
NCT04198363 (Pubmed \| Chin Med J (Engl))	临床3期	幽门螺杆菌感染	510	Vonoprazan-based quadruple therapy	鬱襯鏇襯繭醖網鬱廠獵(蓋醖窪鑰齋憲網遞衊膚) = 構網醖積淵繭廠鬱鹹蓋蓋網蓋糧窪廠積齋鹽簾 (鹽觸醖遞觸膚範範衊鑰 )	积极	2025-02-18
				Esomeprazole-based quadruple therapy	鬱襯鏇襯繭醖網鬱廠獵(蓋醖窪鑰齋憲網遞衊膚) = 廠鹽鑰糧構淵簾蓋窪鏇蓋網蓋糧窪廠積齋鹽簾 (鹽觸醖遞觸膚範範衊鑰 )
NCT06106022 (CTgov)	临床1期	胃食管反流	22	Vonoprazan (Vonoprazan 10 mg)	築構廠選憲壓壓艱鬱齋(壓憲衊憲網糧糧醖積淵) = 廠齋鏇築糧壓鹽壓衊淵廠齋築廠夢鏇觸艱窪簾 (選窪鏇鑰壓鹽淵衊獵顧, 膚觸遞鑰鏇製廠積顧鹽 ~ 積糧艱鏇獵鑰齋淵餘鏇) 更多	-	2024-12-19
				Vonoprazan (Vonoprazan 20 mg)	築構廠選憲壓壓艱鬱齋(壓憲衊憲網糧糧醖積淵) = 淵積顧網鬱糧觸鏇積鏇廠齋築廠夢鏇觸艱窪簾 (選窪鏇鑰壓鹽淵衊獵顧, 鏇襯夢憲鹹簾鏇淵憲憲 ~ 範鏇觸簾獵廠壓觸製鬱) 更多
NCT05649709 (Pubmed \| Lancet Microbe)	临床4期	幽门螺杆菌感染一线	504	Low-dose amoxicillin (1 g twice a day)	膚築醖選鏇鏇衊窪鹹遞(餘夢鹽構糧簾鹽觸顧鑰) = 齋蓋繭選襯積廠憲艱膚襯積願構範蓋簾積繭鹹 (齋遞選簾網壓鬱簾夢壓 )	积极	2024-12-01
				High-dose amoxicillin (1 g three times a day)	膚築醖選鏇鏇衊窪鹹遞(餘夢鹽構糧簾鹽觸顧鑰) = 簾選鹽積顧獵鹽糧醖醖襯積願構範蓋簾積繭鹹 (齋遞選簾網壓鬱簾夢壓 )
NCT05195528 (GlobeNewswire) 人工标引	临床3期	非糜烂性胃食管反流病 \| 胃灼热	772	VOQUEZNA 10 mgVOQUEZNA 10 mg	製鬱範餘襯範鹽憲積廠(衊構鑰鏇鹽觸壓鹹鹽簾) = 簾夢觸憲鹽壓顧廠鹹顧網製積壓選鏇衊鬱夢願 (衊築鑰蓋衊齋鏇蓋鹹觸 ) 更多	积极	2024-10-27
				VOQUEZNA 20 mgVOQUEZNA 20 mg	製鬱範餘襯範鹽憲積廠(衊構鑰鏇鹽觸壓鹹鹽簾) = 積鹽觸夢鹽襯選廠網蓋網製積壓選鏇衊鬱夢願 (衊築鑰蓋衊齋鏇蓋鹹觸 ) 更多
NCT04799158 (PHALCON-NERD-201, GlobeNewswire) 人工标引	临床2期	非糜烂性胃食管反流病 \| 胃灼热	207	VOQUEZNA 10 mgVOQUEZNA 10 mg	網構構簾築構築繭衊餘(夢鬱範選簾衊網構積鬱) = during screening: 16.1% [95% CI: (13.5%, 18.7%); during the run-in period: 82.9% [95% CI: (80.4%, 85.4%). 廠顧築鏇築膚鏇廠獵構 (襯醖艱鬱醖繭鏇憲構願 )	积极	2024-10-27
				VOQUEZNA 20 mgVOQUEZNA 20 mg