Eradication Therapy for Helicobacter pylori Infection in Patients with Penicillin Allergy or Resistance: A Real-World Study Based on Domestic P-CAB Tegoprazan Dual Therapy

开始日期2025-06-01

申办/合作机构-

NCT06977841

/ Not yet recruitingN/AIIT

Efficacy and Safety of Tegoprazan-Amoxicillin and Tegoprazan-Tetracycline Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Study

Current first-line Helicobacter pylori eradication protocols involve multidrug regimens comprising a proton pump inhibitor (PPI) or bismuth agent combined with dual antibiotics (e.g., clarithromycin, amoxicillin, quinolones, furazolidone, nitroimidazoles, or tetracycline) administered for 7-14 days. In China, the bismuth-containing quadruple therapy (BQT) remains the standard first-line treatment for H. pylori infection. However, BQT implementation is challenged by polypharmacy burdens, substantial adverse events, and suboptimal treatment adherence. Emerging evidence suggests that simplified dual therapies pairing acid suppressants (PPIs or potassium-competitive acid blockers [P-CABs]) with high-dose amoxicillin achieve comparable eradication rates to BQT while demonstrating superior tolerability and adherence profiles. Notably, the comparative efficacy of tetracycline-based versus amoxicillin-based dual regimens remains unexamined in controlled clinical trials. Our preliminary investigations established that optimized PPI-amoxicillin dual therapy achieves >90% eradication rates in treatment-naïve populations. Building on these findings, this prospective randomized controlled trial will comparatively assess the effectiveness of tegoprazan-a novel P-CAB exhibiting potent acid inhibition-when co-administered with either amoxicillin or tetracycline in H. pylori-positive adults. The investigation aims to establish an evidence framework for streamlining eradication protocols through pharmacodynamic optimization while mitigating antimicrobial resistance development.

开始日期2025-05-10

申办/合作机构

复旦大学附属中山医院

NCT06894992

/ Not yet recruitingN/AIIT

A Comparison of the Effectiveness of Tegoprazan and Lansoprazole in Achieving Cure Rates in Patients with Bleeding Peptic Ulcers: a Double-Blind Randomized Trial

The goal of this clinical trial is to compare the effects of tegoprazan vs lansoprazole in healing bleeding peptic ulcers. It will also teach about the safety of both modalities. The main questions it aims to answer are:
How does the effectiveness of Tegoprazan compare with Lansoprazole in two weeks of healing rate bleeding peptic ulcer patients in the Indonesian population?
Researchers will compare the drug tegoprazan to lansoprazole with a double-blind randomized control to see their effect on healing bleeding peptic ulcers.
Participants will:
Take drug tegoprazan 50 mg OD or lansoprazole 30 mg OD every day for 2 weeks Endoscopic examination at the beginning before treatment and after completion of treatment within 2 weeks Record of their adverse effect occurrence

开始日期2025-04-07

申办/合作机构-

100 项与替戈拉生相关的临床结果

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100 项与替戈拉生相关的转化医学

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100 项与替戈拉生相关的专利（医药）

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128

项与替戈拉生相关的文献（医药）

2025-09-01·AMERICAN HEART JOURNAL

Potassium-competitive acid blocker vs proton-pump inhibitor in patients receiving antithrombotic therapy who are at high risk for gastrointestinal bleeding: Rationale and design of the randomized PROTECT- HBR trial

Article

作者: Lee, Jinho ; Park, Hwan-Cheol ; Kim, Byeong-Keuk ; Park, Han-Su ; Kim, Sang Min ; Choi, Kee Don ; Park, Seung-Jung ; Lee, Jong-Young ; Yang, Tae-Hyun ; Jin, Eun-Sun ; Kim, Weon ; Lim, Young-Hyo ; Yoon, Myeong-Ho ; Her, Sung-Ho ; Kim, Sang-Hyun ; Lee, Junghoon ; Lee, Wang Soo ; Park, Hanbit ; Hong, Soon Jun ; Suh, Jung-Won ; Kwon, Sung Uk ; Park, Kyoung-Ha ; Kang, Do-Yoon ; Nam, Chang-Wook ; Shin, Eun-Seok ; Park, Duk-Woo ; Ahn, Jung-Min ; Kang, Se Hun ; Yoon, Yong-Hoon ; Choi, Eue-Keun ; Choi, Young Jin ; Jeong, Jin-Ok

BACKGROUND:

Concomitant use of proton pump inhibitor (PPI) is recommended in patients receiving chronic antithrombotic therapy who are at high risk of gastrointestinal (GI) bleeding. However, long-term safety and efficacy of chronic PPI use have been concerned. Potassium-competitive acid blocker (P-CAB) is a novel class of acid suppressants, providing more acid stability, rapid onset of action, less variability with CYP2C19 polymorphisms, and longer duration of action than PPI.

DESIGN:

The PROTECT-HBR trial is a multicenter, randomized, double-blind, double-dummy, parallel-group clinical trial. Approximately 3320 patients with known cardiac or vascular disease receiving antithrombotic drugs (either antiplatelet or anticoagulant agents) and who are at high risk of GI bleeding will be randomized to P-CAB (tegoprazan 50mg once daily) or PPI (rabeprazole 20mg once daily) for up to 12 months. The primary endpoint is a composite outcome of upper GI clinical events, including overt or occult GI bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation, at 12 months. Secondary endpoints also included cardiovascular events and safety outcomes.

RESULTS:

As of December 2024, approximately 1460 patients were enrolled from 32 participating sites in South Korea. The complete enrollment is anticipated at the mid- or late-term of 2025, and the primary results will be available by 2027.

CONCLUSION:

PROTECT-HBR is a large-scale, multicenter, clinical trial, which will provide a pivotal comparison of the efficacy and safety of novel P-CAB, tegoprazan with those of PPI, rabeprazole in patients with documented cardiac or vascular disease receiving chronic antithrombotic drugs and at high risk of GI bleeding.

CLINICAL TRIAL REGISTRATION:

Potassium-Competitive Acid Blocker versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High GastroIntestinal Bleeding Risk Receiving Antithrombotic Therapy (PROTECT-HBR): NCT04416581.

2025-07-01·BIOMEDICINE & PHARMACOTHERAPY

Restoration of intestinal barrier function by fexuprazan, a potassium-competitive acid blocker, in Caco-2 cells and its higher gastrointestinal distribution in rats

Article

作者: Baek, Yeon-Ju ; Choi, Min-Koo ; Lim, Kwon-Jo ; Song, Im-Sook ; Park, Joon Seok ; Kim, Ji Duck ; Lee, Jihoon ; Jeon, Ji-Hyeon

This study aimed to investigate the efficacy of fexuprazan in restoring intestinal barrier function in comparison with other potassium-competitive acid blockers (P-CABs) and esomeprazole. The effect of fexuprazan on trans-epithelial electrical resistance (TEER) value, mRNA and protein expression of tight junction genes, and cell morphology was investigated using a dextran sulfate sodium (DSS)-induced ulcerative colitis Caco-2 cell model. Treatment with fexuprazan, esomeprazole, tegoprazan, and vonoprazan significantly increased TEER values in a 3 % DSS-induced ulcerative colitis Caco-2 cells in a concentration-dependent manner. The TEER value-concentration profile showed sigmoidal shape curves and yielded half maximal effective concentration of 0.983 - 1.17 μg/mL for P-CABs and 3.27 μg/mL for esomeprazole. Among these drugs, fexuprazan showed the highest activity in the restoring intestinal barrier function. Fexuprazan also increased the expression of tight junction genes including zonula occludens-1, claudin 1, occludin, and mucin 1, and also thickened the epithelial cell membrane after treatment with 20 μg/mL fexuprazan. Fexuprazan showed a particularly high distribution in the liver and gastrointestinal tract in rats following oral administration of 2 mg/kg fexuprazan, which appears to be a positive characteristic of fexuprazan's effect on ulcerative colitis and gastric acid-related diseases although in vivo therapeutic efficacy of fexuprazan for ulcerative colitis requires further validation in both animal and human. In conclusion, fexuprazan can potentially restore intestinal barrier function by increasing the expression of tight junction genes and by strengthening the cell membrane integrity in DSS-induced colitis model.

2025-05-01·Pharmacoeconomics-Open

So Many Choices, So Little Value: Potential Savings from Selecting Cost-Effective Proton Pump Inhibitors

Article

作者: Kwon, Hye-Young

BACKGROUND:

Given that Korea lacks measures to promote cost-effective prescribing, this study investigated the efficiency of prescribers' decision-making when faced with the choice of 398 products containing 15 proton pump inhibitors (PPI).

OBJECTIVE:

This study aimed to explore PPI prescribing patterns in ambulatory care over 10 years and elucidate prescribers' practices. Further analysis was conducted to estimate the achievable potential savings, assuming that the recommendation of first-choice drugs is based on the rational use of medicines.

METHODS:

Retrospective PPI prescribing data from the ambulatory sector pertaining to medical services provided to the entire South Korean population from 2013 to 2022 were extracted from the Korean National Health Information Database; the data were analyzed to identify annual trends in PPI spending and utilization volume according to defined daily doses (DDDs). Unit price per DDD was calculated, and a preferred cost-effective choice with identical efficacy and safety profile was selected among PPIs. The potential savings were then simulated using Dirichlet distribution.

RESULTS:

In ambulatory care, PPI drug costs increased by 13.0% per annum over 10 years. The preferred substances were esomeprazole (31.6%), rabeprazole (23.2%), and tegoprazan (16.5%), which are among the most expensive PPIs. However, the most cost-effective substance was dexlansoprazole (South Korean won [KRW] 522.7; standard deviation [SD] = 72.2; and median = 583). If dexlansoprazole is recommended as the first-choice PPI in the Korean context, the estimated cost savings would be 404.24 billion KRW, equivalent to 47.0% of the current PPI spending in ambulatory care.

CONCLUSIONS:

This study identified opportunities for substantial cost savings related to PPI prescribing. Guided decision-making toward cost-effective PPI prescribing would increase the efficiency of prescribing and the sustainability of the healthcare system.

157

项与替戈拉生相关的新闻（医药）

2025-05-28

·米内网

53款国产1类新药“起飞”！3大超40亿品种领跑，6大品种涨逾100%，恒瑞大爆发

精彩内容近段时间，创新药领域风起云涌：1类新药密集获批，国产新药出海再现“天价”交易等。据不完全统计，2018年至今（截至5月27日，下同），国内有超150款国产1类新药获批上市，以抗肿瘤和免疫调节剂为主，恒瑞医药强势领跑。从销售额看，53款国产1类新药2024年在中国三大终端六大市场销售过亿，16个超10亿大爆品亮眼。随着创新药的逐步放量，以及BD项目不断刷新交易额记录，创新药企有望迎来扭亏为盈的密集期。超150款国产1类新药获批！恒瑞强势领跑近年来，随着药品审评审批制度改革、全链条支持创新药等系列政策出台，我国创新药进入全面爆发阶段。米内网数据显示，2018年至今，国内有超150款国产1类新药（按新版注册管理办法，不含中成药、原料药、疫苗等）获批上市，其中化学药占比超过65%，治疗用生物制品占比超过34%。从时间段看，2020年新版药品注册管理办法实施后，国产1类新药获批数量大幅提升，由2018及2019年的个位数，增长至2020年的13个，2021年突破20个，2022年有所回落，2023及2024年均达30个及以上，预计2025年有望再创新高。2018年至今获批上市的国产1类新药（不含中成药）注：以最早获批年份计从治疗领域看，超150款国产1类新药分布在11个治疗大类，集中在抗肿瘤和免疫调节剂，共计78个，占比超过49%；此外，全身用抗感染药物、消化系统及代谢药分别有29个、18个品种在列，占比分别超过18%、11%。虽然我国创新药仍有扎堆肿瘤领域的现象，但在代谢、麻醉、自免、心血管、抗病毒、皮肤等领域亦有涉及，逐渐呈现“全面开花”之势。超150款国产1类新药治疗大类分布情况米内网数据显示，近年来中国三大终端六大市场抗肿瘤和免疫调节剂（不含中成药，下同）、消化系统及代谢药销售额均超过2000亿元，全身用抗感染药物销售额均超过1600亿元。从企业看，20余家药企（按集团计）均有2个及以上的新药获批，其中恒瑞医药以16个品种强势领跑，正大制药、浙江我武生物以6个品种并列第二，豪森药业以5个品种排位第四，海思科、康方生物以4个品种并列第五。此外，百济神州、贝达药业、东阳光药、和黄医药、石药集团、再鼎医药、四环医药、君实生物、信达生物等均有3个品种在列。获批品种数TOP5集团注：以上市许可持有人计16个超10亿大爆品亮眼！这些品种上市即起飞从商业化后的销售额看，2018至2023年获批的国产1类新药中，有53款2024年在中国三大终端六大市场的销售额超过1亿元，合计销售额超过500亿元。16个超10亿大品种亮眼，百济神州的替雷利珠单抗注射液、信达生物的信迪利单抗注射液、豪森药业的甲磺酸阿美替尼片依次位列前三，销售额均超40亿元；正大天晴药业的盐酸安罗替尼胶囊以超38亿元紧接在后，恒瑞医药的注射用卡瑞利珠单抗、百济神州的泽布替尼胶囊、先声药业的依达拉奉右莰醇注射用浓溶液均超20亿元。从增长情况看，恒瑞医药的瑞维鲁胺片及脯氨酸恒格列净片、山东罗欣药业的替戈拉生片、华领医药的多格列艾汀片、成都微芯药业的西格列他钠片、荣昌生物的注射用泰它西普等涨幅均超过100%（2023年获批的品种不计在内）。2018至2023年获批且销售额超过1亿元的国产1类新药注：标红为增速超10%，2023年获批的品种不计在内来源：米内网综合数据库恒瑞医药以9个品种领跑。注射用卡瑞利珠单抗（PD-1单抗）、马来酸吡咯替尼片（多靶点激酶抑制剂）、海曲泊帕乙醇胺片（TPO受体激动剂）、瑞维鲁胺片（AR受体拮抗剂）、羟乙磺酸达尔西利片（CDK4/6抑制剂）、阿得贝利单抗注射液（PD-L1单抗）在上市首年或次年销售额即超过1亿元，其中2018年获批的马来酸吡咯替尼片，2019年销售额接近8亿元，2021年超过19亿元，之后有所波动，2025年超过16亿元；2021年获批的海曲泊帕乙醇胺片，2022年销售额接近6亿元，2023年突破12亿元，2024年突破15亿元；此外，脯氨酸恒格列净片（SGLT2抑制剂）最早于2021年获批，2024年销售额增速约达475%。近年来中国三大终端六大市场恒瑞医药部分1类新药销售情况（单位：万元）来源：米内网格局数据库豪森药业有4个品种在列。甲磺酸阿美替尼片（三代EGFR抑制剂）、甲磺酸氟马替尼片（BCR-ABL抑制剂）、艾米替诺福韦片（核苷酸类逆转录酶抑制剂）在上市首年或次年销售额即超过1亿元，其中2020年获批的甲磺酸阿美替尼片，当年销售额即接近5亿元，2021年超过16亿元，2024年突破40亿元；2021年获批的艾米替诺福韦片，2022年销售额接近3亿元，2024年突破8亿元，作为一款非肿瘤药，该新药上市后的市场表现让人眼前一亮。近年来中国三大终端六大市场豪森药业部分1类新药销售情况（单位：万元）来源：米内网格局数据库作为国内首款获批的国产双抗，以及全球首款获批的PD-1/CTLA-4双抗，康方生物的卡度尼利单抗注射液不负众望，上市后市场表现亮眼。该药最早于2022年获批上市，当年销售额即超过3亿元，2023年突破12亿元，2024年突破15亿元。目前卡度尼利单抗注射液已有宫颈癌（二线）、胃癌（一线）等适应症获批，非小细胞肺癌、肝细胞癌等适应症处于III期临床。近年来中国三大终端六大市场卡度尼利单抗注射液销售情况（单位：万元）来源：米内网格局数据库激励政策频出，创新药企将迎业绩拐点近几年来，国家层面频频出台利好政策，创新药的研发、审评、生产和支付等环节的政策环境显著优化。2024年以来，创新药产业支持政策持续加码，从支付渠道拓展、目录动态调整到临床应用保障等方面构建了全链条支持体系，旨在缩短创新药上市周期并优化市场环境。在利好政策支撑下，越来越多的创新药在进入医保后实现快速放量，国产创新药在与MNC（跨国药企）合作中不断刷新交易额记录，并在海外市场陆续兑现商业化预期，这些都标志着我国医药产业的高质量创新已逐步迈入兑现期。据2024年业绩报告显示，以百济神州为代表的众多创新药企业绩相比往年显著好转，预示着整个创新药板块有望迎来盈利拐点。A股“研发投入一哥”百济神州表现亮眼，2024年营业收入272.14亿元（+56.2%），其中产品收入269.94亿元（+74.1%），亏损进一步收窄约26.9%。业绩增长的关键因素是其核心产品的出色表现，2024年泽布替尼销售额高达188.59亿元，在公司总营收中占比超六成；替雷利珠单抗销售额44.67亿元，同比增长17.4%。依靠产品收入增长和授权费收入增加，以及持续改善运营效率，信达生物2024年业绩大涨，其营业收入94.22亿元（+51.8%），其中产品收入82.28亿元（+43.6%），授权费收入则由4.47亿元翻倍增加至11亿元；年内亏损降至9463.1万元，同比缩窄90.8%，年内Non-IFRS（非国际财务报告准则）利润、Non-IFRS EBITDA（税息折旧及摊销前利润）双双首次转正。得益于卡度尼利单抗销售持续增长和依沃西单抗在2024年5月获批上市后带来的积极销售贡献，康方生物2024年扣除分销成本后的商业销售收入达20.02亿元，同比增长24.88%。康方生物董事会主席夏瑜表示：“2025年是公司产品进入医保的元年。到目前为止，还在非常快速放量起量的过程之中。”BD项目收入成为康宁杰瑞业绩扭亏为盈的关键，2024年公司实现总收入6.4亿元，同比增长192.58%，年内溢利约为1.66亿元，上年同期则为亏损2.11亿元。这一年，康宁杰瑞分别与ArriVent、Glenmark以及石药集团达成三笔合作，交易总金额超125亿元。资料来源：米内网数据库、公司公告注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：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5月27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

免疫疗法上市批准疫苗

2025-05-21

·米内网

【聚焦】8亿畅销产品，罗欣药业入局抢食

精彩内容近日，罗欣药业旗下山东裕欣药业提交了富马酸伏诺拉生片的4类仿制上市申请，该产品是治疗与胃酸分泌相关疾病的畅销药物，2024年在中国三大终端六大市场（统计范围见文末）的销售额超过8亿元。在该类药物市场，罗欣药业为TOP4集团（一级），新品上市有望进一步提升公司的市场竞争力。图1：山东裕欣药业最新申报的产品来源：CDE官网富马酸伏诺拉生片用于治疗反流性食管炎，以及与适当的抗生素联用以根除幽门螺杆菌，米内网数据显示，目前该产品的竞争格局（原研+国产）已超过10家。图2：富马酸伏诺拉生片的销售情况（单位：万元）来源：米内网格局数据库近几年在中国三大终端六大市场，富马酸伏诺拉生片的销售额一路狂飙，2024年涨至接近8.3亿元，为近五年峰值。在治疗与胃酸分泌相关疾病的药物市场，富马酸伏诺拉生片已跃升为TOP15产品。从渠道来看，公立医院终端（城市公立医院+县级公立医院）依然是富马酸伏诺拉生片的销售主阵地，而该产品在零售药店终端（城市实体药店+网上药店）近两年的增速高达553.35%、42.96%，潜力不容小觑。2024年在中国三大终端六大市场，罗欣药业是治疗与胃酸分泌相关疾病的药物TOP4集团（一级），公司在该类药物市场的过亿产品包括了替戈拉生片（1类新药）、注射用雷贝拉唑钠、奥美拉唑肠溶胶囊等。表1：2024年罗欣药业的治疗与胃酸分泌相关疾病的药物销售正增长的产品来源：米内网格局数据库表2：2023年至今罗欣药业（含子公司）获批的新品（不含2.4类）来源：米内网中国申报进度（MED）数据库2023年至今，罗欣药业陆续获批了盐酸乌拉地尔注射液、利伐沙班片、盐酸伐昔洛韦片、雷贝拉唑钠肠溶片和盐酸左沙丁胺醇雾化吸入溶液，其中雷贝拉唑钠肠溶片为公司在治疗与胃酸分泌相关疾病的药物市场再添重磅一员。资料来源：CDE官网、米内网数据库注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：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5月21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生物类似药

2025-05-07

·inno-n.com

HK inno.N and Tabuk Expand Cooperation on New Drug K-CAB for GERD for 6 MENA Countries

- Expansion follows an exclusive License and Supply Agreement signed in 2024 with Tabuk Pharmaceuticals for K-CAB in ten countries in the Middle East and North Africa - K-CAB has now entered 54 countries worldwide and is continuing its global expansion K-CAB, HK inno.N’s new drug for gastroesophageal reflux disease (GERD), is expanding its presence in the global market. HK inno.N announced on the 7th (MAY 7) that the company recently expanded its collaboration with Tabuk Pharmaceuticals for K-CAB tablets (active ingredient tegoprazan), its new GERD treatment, to include additional six countries in the MENA region. HK inno.N signed an Agreement with Tabuk Pharmaceuticals in 2024 to for the exclusive License and Supply rights in 10 countries in the Middle East and North Africa. The new agreement with Tabuk Pharmaceuticals will expand the territory to include 6 new MENA countries; Egypt, Sudan, Ethiopia, Morocco, Yemen, and Libya. In addition to exporting technology, K-CAB is expanding its global presence through the export of finished products. Including this agreement, the company has reached a total of 53 overseas countries, excluding Korea. Tabuk Pharmaceuticals is a leading Saudi pharmaceutical company with a regional presence in the Middle East and North Africa with strong distribution and marketing capabilities across the Middle East and North Africa and is expected to play an important role in the market penetration and expansion of K-CAB in the MENA region. Kwak Dal-won, CEO of HK inno.N, said, “With this agreement, we have reached 53 countries, more than halfway to our goal of reaching 100 countries by 2028. We will continue to work closely with our partners in each country to establish K-CAB as a paradigm-shifting new drug for the treatment of GERD worldwide.” Ismail Shehada, CEO of Tabuk, said “We consider our partnership with HK inno.N to be a strategic pillar of our growth. We are pleased to expand our collaboration not only by extending our presence into additional countries, but also by broadening our portfolio with new products in the future. This reinforces our shared commitment to improving patient access and delivering innovative healthcare solutions globally. ” K-CAB, the 30th new drug in South Korea, is a P-CAB class new drug for GERD treatment and is addressing the market with various formulations (IR tablets, oral disintegrating tablets) and indications (5 in total). It is characterized by rapid onset of action within one hour after administration and proven efficacy and safety even with long-term use for up to six months. Following its first launch in South Korea, K-CAB succeeded in the market entry to a total of 54 countries worldwide and has been officially released in 15 countries to date. K-CAB recorded total outpatient prescription sales of KRW 196.9 billion in 2024 in South Korea. The product has been the steady No. 1 market leader in peptic ulcer medications for five consecutive years. [The End] [Reference information] ■ P-CAB: Potassium Competitive Acid Blocker ■ Overview of K-CAB’s market presence worldwide (54 countries in total): - South Korea, China, Mongolia, India, South Africa, the United States, Canada, Australia, New Zealand - 6 Southeast Asian countries: Indonesia, Thailand, Philippines, Vietnam, Singapore, Malaysia - 5 Eastern European countries: Russia, Kazakhstan, Uzbekistan, Ukraine, Belarus - 18 Central and South American countries: Brazil, Mexico, Argentina, Colombia, Peru, Chile, Ecuador, Uruguay, Paraguay, Bolivia, Venezuela, Dominican Republic, Guatemala, Honduras, Nicaragua, Costa Rica, Panama, El Salvador - 16 Middle Eastern/North African countries: Saudi Arabia, Jordan, Lebanon, UAE, Oman, Kuwait, Bahrain, Iraq, Qatar, Algeria, Egypt, Sudan, Ethiopia, Morocco, Yemen, Libya

引进/卖出上市批准

100 项与替戈拉生相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	A02BC	DB16690

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
十二指肠溃疡	中国	山东罗欣药业集团股份有限公司	2023-11-14
反流性食管炎	中国	山东罗欣药业集团股份有限公司	2022-04-08
胃食管反流	韩国	HK inno.N Corp.	2018-07-05
幽门螺杆菌感染	韩国	HK inno.N Corp.	2018-07-05

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
胃溃疡	临床3期	美国	HK inno.N Corp.	2016-05-01
非糜烂性胃食管反流病	临床3期	美国	HK inno.N Corp.	2015-09-22
非糜烂性反流病	临床3期	美国	HK inno.N Corp.	2015-09-22
糜烂性食管炎	临床3期	美国	HK inno.N Corp.	2015-05-01
肝损伤	临床1期	美国	HK inno.N Corp.	2020-09-08

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分期

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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


NCT05883306 (Pubmed \| Expert Opin Drug Metab Toxicol)	临床1期	-	6	Tegoprazan 50 mg/150 μCi	築網顧壓鹹淵艱觸製鹹(遞襯鏇鬱糧艱遞糧襯衊) = 窪蓋鬱廠鏇淵餘醖鹹構獵蓋衊夢艱願夢襯齋淵 (蓋壓襯鹹製膚積齋糧鏇 ) 更多	-	2025-05-13
UEGW2024	N/A	幽门螺杆菌感染一线	80	Tegoprazan-based BQT	積製遞選淵鏇製鏇構鹽(積蓋淵窪願艱廠蓋齋膚) = There was no significant difference in the rate of adverse events between the TBMT and OBMT groups (42.5% vs. 55,5%, p = 0.37). Nausea was the most common adverse effect (37.5% vs 40%, p=0.92) , followed by abdominal pain (12.5% vs 17.5%, p=0.16%) 築簾壓鏇築壓醖淵艱醖 (選廠築廠鹽醖襯願膚範 )	积极	2024-10-13
				Omeprazole-based BQT
UEGW2024	N/A	-	-	Tegoprazan 50mg	鑰網觸艱遞襯選遞淵膚(餘觸範範夢製網築願醖) = No significant differences in the incidence of adverse events between the trial group and the placebo group. No severe adverse events occurred in this study. 憲觸繭鹹糧製糧鹹襯築 (選淵鑰淵觸鏇繭餘製願 )	-	2024-10-13
				Placebo
UEGW2024	N/A	-	-	Esomeprazole-containing sequential therapy	膚願築願築選壓網鬱蓋(襯鹹襯築觸積鹽醖艱網) = In tegoprazan-containing sequential, nausea was more prevalent (23.3%, 27/202), which was statistically higher than esomeprazole-containing sequential (14.2%, 29/204) (p = 0.022) 鹹簾製齋積構顧觸廠憲 (獵範衊觸憲選積繭網糧 )	-	2024-10-13
				Tegoprazan-containing sequential therapy
NCT05010954 (Pubmed \| Curr Med Res Opin) 人工标引	临床3期	十二指肠溃疡	399	Tegoprazan 50 mg	鬱繭遞廠餘醖憲淵積遞(蓋觸窪衊繭簾選獵鏇夢) = 鬱築憲積遞糧衊範衊積餘網窪鬱襯膚壓蓋餘積 (餘餘衊醖築願鹹襯選鬱 ) 更多	非劣	2024-10-08
				Lansoprazole 30 mg	鬱繭遞廠餘醖憲淵積遞(蓋觸窪衊繭簾選獵鏇夢) = 淵顧鑰壓壓製選夢築憲餘網窪鬱襯膚壓蓋餘積 (餘餘衊醖築願鹹襯選鬱 ) 更多
NCT06382493 (Pubmed \| Helicobacter)	N/A	幽门螺杆菌感染	406	Esomeprazole-containing sequential therapy	願積範糧襯淵觸鏇網廠(網齋艱積窪鹽廠艱積廠) = Nausea was more prevalent (23.3%, 27/202) with sequential tegoprazans than with esomeprazole-containing sequential therapy (14.2%, 29/204; p = 0.022) 製選餘窪構鏇衊製積鹽 (鏇觸觸鏇襯糧繭蓋膚憲 )	积极	2024-09-01
				Tegoprazan-containing sequential therapy
NCT05577468 (NEWS) 人工标引	临床3期	幽门螺杆菌感染	555	替戈拉生	齋醖廠膚艱遞艱壓廠觸(糧簾膚構鹽襯醖簾夢夢) = 憲構網顧獵鏇製廠觸壓鏇廠淵壓衊顧積壓繭選 (憲淵廠顧夢膚壓糧繭夢 ) 更多	积极	2024-05-21
				艾司奥美拉唑	齋醖廠膚艱遞艱壓廠觸(糧簾膚構鹽襯醖簾夢夢) = 鹹鹽範膚築築網觸鬱網鏇廠淵壓衊顧積壓繭選 (憲淵廠顧夢膚壓糧繭夢 ) 更多
DDW2024	N/A	-	612	Tegoprazan	繭壓遞膚壓糧積鑰膚積(窪糧遞壓築構顧齋遞廠) = 觸簾膚餘壓願鹽繭範齋觸廠範網製憲醖淵憲餘 (觸鹹網壓醖鏇獵襯築網 ) 更多	积极	2024-05-21
				PPI	繭壓遞膚壓糧積鑰膚積(窪糧遞壓築構顧齋遞廠) = 製鏇餘蓋願衊製夢艱願觸廠範網製憲醖淵憲餘 (觸鹹網壓醖鏇獵襯築網 ) 更多
DDW2024	N/A	-	-	Vonoprazan-based triple therapy	簾鏇積壓憲壓衊遞夢獵(蓋壓遞憲艱遞艱繭獵鬱): RR = 1.17 (95% CI, 1.11 ~ 1.22)	-	2024-05-18
				Conventional PPI-based triple therapy
NCT05870683 (SHARE2301, Pubmed \| Helicobacter)	N/A	幽门螺杆菌感染	368	Tegoprazan-amoxicillin (TA)	壓艱選觸憲鹽鏇觸製餘(衊餘醖窪夢糧壓簾積構) = 齋窪積願鑰憲窪築鬱壓餘襯觸壓淵糧糧壓壓廠 (願鬱顧壓醖蓋餘遞鹹餘 )	积极	2024-05-01
				Esomeprazole-amoxicillin (EA)	壓艱選觸憲鹽鏇觸製餘(衊餘醖窪夢糧壓簾積構) = 願鏇獵積醖廠鹽顧餘鹽餘襯觸壓淵糧糧壓壓廠 (願鬱顧壓醖蓋餘遞鹹餘 )