A Phase 1, Open Label, Randomized, Parallel-group, Single Center Study to Investigate Pharmacokinetics and Pharmacodynamics (Intragastric pH) of Linaprazan Glurate/Linaprazan After Single and 14 Days'Repeated Oral Administration of Linaprazan Glurate to Healthy Subjects

This is a Phase I, single-center, open label parallel-group, randomized study designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD, by continuous intragastric pH measurment), safety and tolerability of single and repeated oral doses of linaprazan glurate in 3 different dose levels given once- (QD) or twice daily (BID), for 14 days, with an additional single dose after 2, 4 or 6 days of drug holiday. The population will include healthy male and female subjects.
The subjects will be followed up to 28 days post IMP dosing.

开始日期2023-01-26

申办/合作机构

Cinclus Pharma Holding AB

NCT05633147

/ Completed临床1期

Effect of Repeated Dosing of Clarithromycin on PK of Linaprazan Glurate/Linaprazan, Effect of Single Dose of Linaprazan Glurate on PK of Clarithromycin, Single/Repeated Dosing of Linaprazan Glurate on PK of Midazolam to Healthy Subjects

This is a phase I, open-label, fixed sequence design, drug-drug-interaction (DDI) study divided in 2 parts. Part I is designed to evaluate whether concomitant treatment with linaprazan glurate and clarithromycin, a strong inhibitor of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein P (PgP), leads to an effect on the systemic exposure to linaprazan glurate and linaprazan and whether there is an effect on the pharmacokinetics of clarithromycin after a single dose of linaprazan glurate. Part II is designed to evaluate the effect of repeated doses of linaprazan glurate on the pharmacokinetics (PK) of a sensitive substrate of CYP3A (midazolam).

开始日期2022-11-27

申办/合作机构

Cinclus Pharma Holding AB

NCT05627518

/ Completed临床1期

A Randomized, Single Dose, Crossover Study in Healthy Volunteers to Investigate the Relative Bioavailability of Linaprazan for a New Oral Tablet Formulation of Linaprazan Glurate, and to Assess the Effect of Food on the Pharmacokinetics of Linaprazan

This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a previously studied oral tablet formulation under fasting conditions, and to assess the effect of a high fat, high calorie meal on the pharmacokinetics (PK) of linaprazan glurate and the active substance linaprazan after the administration of the new oral tablet formulation.

开始日期2022-11-15

申办/合作机构

Cinclus Pharma Holding AB

100 项与戊二酸利那拉生酯相关的临床结果

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100 项与戊二酸利那拉生酯相关的转化医学

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100 项与戊二酸利那拉生酯相关的专利（医药）

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项与戊二酸利那拉生酯相关的文献（医药）

2025-05-01·ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Clinical Trial: Dose‐Finding Study of Linaprazan Glurate, A Novel Potassium‐Competitive Acid Blocker, Versus Lansoprazole for the Treatment of Erosive Oesophagitis

Article

作者: Unge, Peter ; Andersson, Kjell ; Popadiyn, Ivan ; Rosenholm, Maria ; Yektaei, Elham ; Vaezi, Michael ; Sharma, Prateek ; Larsson, Kajsa ; Armstrong, David ; Rosztóczy, Andras

ABSTRACT:

Background:

Linaprazan glurate, a potassium‐competitive acid blocker, is in development for the treatment of erosive oesophagitis and other acid‐related diseases.

Aim:

To evaluate the 4‐week healing rate and safety of four linaprazan glurate dosing regimens in patients with erosive oesophagitis.

Methods:

This double‐blind, dose‐finding study compared linaprazan glurate to lansoprazole. We included patients with endoscopically confirmed erosive oesophagitis (validated by a central review board) if they had Los Angeles (LA) grade C/D or LA grade A/B with partial response to at least 8 weeks of proton pump inhibitor therapy. Patients were randomised to 4 weeks of linaprazan glurate (25, 50, 75 or 100 mg twice daily) or lansoprazole (30 mg once daily), followed by 4 weeks of open‐label lansoprazole.

Results:

Of 248 patients randomised, central review confirmed erosive oesophagitis in 182 at screening endoscopy. Across all doses, linaprazan glurate achieved a 4‐week healing rate of 71.1% in intention‐to‐treat (ITT) analysis and 80.9% in per protocol (PP) analysis. In comparison, lansoprazole achieved healing rates of 60.6% (ITT) and 59.1% (PPS). The best performing linaprazan glurate dosing group outperformed lansoprazole by 28% in patients with LA grade A/B with partial PPI response and by more than 50% in patients with LA grade C/D.

Conclusions:

Linaprazan glurate demonstrated high 4‐week healing rates compared to lansoprazole, with a good safety profile, supporting its further development.

Trial Registration:

ClinicalTrials.gov: NCT05055128; EudraCT: 2020‐003319‐91

2024-11-01·Current gastroenterology reports

Potassium-competitive Acid Blockers: Current Clinical Use and Future Developments

Review

作者: Scarpignato, Carmelo ; Hunt, Richard H

Abstract:

Purpose of the Review:

Acid suppression with proton pump inhibitors (PPIs) represents the standard of care in the treatment of acid-related diseases. However, despite their effectiveness, PPIs display some intrinsic limitations, which underlie the unmet clinical needs that have been identified over the past decades. The aims of this review are to summarize the current status and future development of the new class of antisecretory drugs (potassium-competitive acid blockers, P-CABs) that have recently been introduced into medical practice.

Recent Findings:

Over the past decades, clinical needs unmet by the current acid suppressants have been recognized, especially in the management of patients with GERD, Helicobacter pylori infection and NSAID-related peptic ulcer. The failure to address these needs is mainly due to their inability to achieve a consistent acid suppression in all patients and, particularly, to control nighttime acidity. It was then realized that an extended duration of acid suppression would exert additional benefits. The available data with P-CABs show that they are able to address these unmet clinical needs.

Summary:

Four different P-CABs (vonoprazan, tegoprazan, fexuprazan and keverprazan) are currently available. However, only two of them are approved outside Asia. Vonoprazan is available in North, Central and South America while tegoprazan is marketed only in Latin American countries. Two other compounds (namely linazapran glurate and zestaprazan) are presently under clinical development. While clinical trials on GERD have been performed with all P-CABs, only vonoprazan and tegoprazan have been investigated as components of Helicobacter pylori eradication regimens. The available data show that—in the above two clinical indications—P-CABs provide similar or better efficacy in comparison with PPIs. Their safety in the short-term overlaps that of PPIs, but data from long-term treatment are needed.

2024-05-01·Journal of pharmaceutical and biomedical analysis

Absorption, distribution, metabolism and excretion of linaprazan glurate in rats

Article

作者: Zhang, Xinyue ; Yuan, Yali ; Zheng, Yuandong ; Diao, Xingxing ; Yang, Ying ; Yang, Chen ; Xiu, Jin ; Lu, Ming ; Liu, Donghui ; Hu, Pingsheng

Linaprazan (AZD0865, TX07) is one of potassium-competitive acid blockers. However, linaprazan is rapidly excreted from the body, shortening its acid inhibition property. Linaprazan glurate (X842) is a prodrug of linaprazan with a prolonged inhibitory effect on gastric acid secretion. Linaprazan glurate has entered clinical trials, but few studies have reported its metabolism in non-clinical and clinical settings. In this study, we studied the pharmacokinetics, tissue distribution, mass balance, and metabolism of linaprazan glurate in rats after a single oral dose of 2.4 mg/kg (100 µCi/kg) [¹⁴C]linaprazan glurate. The results demonstrated that linaprazan glurate was mainly excreted via feces in rats with 70.48% of the dose over 168 h. The plasma AUC₀_-_∞ of linaprazan glurate in female rats was 2 times higher than that in male rats. Drug-related substances were mainly concentrated in the stomach, eyes, liver, small intestine, and large intestine after administration. In blood, drug-related substances were mostly distributed into plasma instead of hemocytes. In total, 13 metabolites were detected in rat plasma, urine, feces, and bile. M150 (2,6-dimethylbenzoic acid) was the predominant metabolite in plasma, accounting for 80.65% and 67.65% of AUC_0-24_h in male and female rats, respectively. Based on the structures, linaprazan glurate was mainly hydrolyzed into linaprazan, followed by a series of oxidation, dehydrogenation, and glucuronidation in rats. Besides, CES2 is the main metabolic enzyme involved in the hydrolysis of linaprazan glurate to linaprazan.

项与戊二酸利那拉生酯相关的新闻（医药）

2025-05-22

·FiercePharma

Zentiva inks €220M deal to commercialize AstraZeneca GI cast-off in Europe

Cinclus Pharma was founded in 2014 by a group of former AstraZeneca employees who wanted to take linaprazan further. Former Sanofi subsidiary Zentiva has signed off on up to 220 million euros for the rights to commercialize and manufacture an ex-AstraZeneca asset for gastric-acid-related diseases in Europe.Under the terms of the deal, Zentiva is paying Cinclus Pharma 13 million euros upfront, with a near-term milestone payment of 5 million euros to follow next year, according to a May 22 release. The total possible value of the agreement, at 220 million euros, includes the upfront payment and all commercial and regulatory milestones. In return, Zentiva has secured the rights to commercialize and manufacture linaprazan glurate in Europe. Cinclus can also receive tiered double-digit royalties on net sales in Europe. The partnership applies to the U.K., Switzerland and all the countries in the European Economic Area.“This alliance establishes a fully integrated set of capabilities covering everything necessary to bring linaprazan glurate to the market across Europe,” Cinclus CEO Christer Ahlberg said in the release. “This collaboration not only de-risks our path to European approval but also positions us to capture significant global value, particularly in the U.S. market where we retain full commercial rights and see a substantial commercial opportunity.”Linaprazan glurate is a potassium-competitive acid blocker that Cinclus is developing for severe erosive gastroesophageal reflux disease (eGERD). Cinclus, which is based in Sweden, plans to test the asset in a phase 3 trial starting in the third quarter of this year.Linaprazan glurate was approved by Chinese regulators as a GERD treatment in December 2024, and Cinclus has previously set out plans to launch the drug itself in China this year. eGERD occurs when stomach acid backs up into the esophagus, damaging the gastric tube’s lining. The condition can cause heartburn, trouble swallowing and chest pain, among other symptoms.Linaprazan was initially developed by AstraZeneca and tested in phase 1 and 2 trials between 2001 and 2005, according to Cinclus’ website. Cinclus was founded in 2014 by a group of former AstraZeneca employees who wanted to take the molecule further after the Big Pharma lost interest in the drug.Cinclus unveiled data from a phase 2 dose-selection study of linaprazan in November 2022. The study compared linaprazan with over-the-counter competitor lansoprazole but was not statistically powered to test whether there was a significant difference between the two, Cinclus said at the time. A post hoc analysis of the data found that eGERD patients treated with linaprazan glurate had higher rates of healing, as assessed by an endoscopic evaluation, than those given lansoprazole, Cinclus said.Zentiva also has a history with Big Pharma; the Czech drugmaker was a subsidiary of Sanofi from 2008 to 2018, with a focus on generics. Zentiva was acquired by private equity firm Advent International in 2018 and is now taking a turn into brand-name products.“This partnership marks a key milestone for Zentiva as we continue expanding our portfolio beyond generics into high-value specialty medicines,” Zentiva Chief Scientific Officer Martin Albert said in the release. “Linaprazan glurate is a complementary asset that perfectly fits our strategy to leverage our excellence in generics and deliver game-changing treatments to patients across Europe.”

上市批准临床1期引进/卖出临床2期并购

2025-05-22

·cincluspharma.com

Cinclus Pharma Partners with Zentiva to Commercialize Linaprazan Glurate in Europe

Cinclus Pharma establishes a strategic alliance and licensing agreement with Zentiva, a leading European pharmaceutical company, for the commercialization and manufacturing of its lead asset, linaprazan glurate, in Europe. The agreement covers all member states in EEA, UK and Switzerland. The total deal value, including upfront and regulatory and commercialization milestone payments is EUR 220 million, which includes an upfront payment of EUR 13 million and a near-term milestone of EUR 5 million in 2026. Cinclus Pharma is also entitled to tiered double-digit royalties on net sales in Europe, starting in the high-teens and exceeding 20% at the highest tier levels. Cinclus Pharma Holding AB (publ) (STO: CINPHA), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of gastric acid-related diseases, today announced an agreement with Zentiva k.s., a leading European pharmaceutical company, for the commercialization and manufacturing of its lead asset, linaprazan glurate, in Europe. The product is a next-generation potassium-competitive acid blocker (PCAB) designed for the treatment of severe erosive gastroesophageal reflux disease (eGERD). The addressable market is estimated at 19 million patients globally, including approx. 10 million across Europe and the US. Cinclus Pharma expects to initiate its first Phase III study with linaprazan glurate in Q3 2025. The total deal value, including an upfront payment and all regulatory and commercial milestones is EUR 220 million (approximately SEK 2,4 billion). As part of the transaction, Zentiva will make an upfront payment of EUR 13 million (approximately SEK 143 million) and Cinclus Pharma is eligible for a near-term milestone payment of EUR 5 million (approximately SEK 55 million) in 2026. Cinclus Pharma is also eligible to receive tiered double-digit royalties on net sales in Europe, starting in the high teens and exceeding 20% at the highest tiers. “The alliance with Zentiva marks a significant inflection point for Cinclus Pharma,” said Christer Ahlberg, CEO of Cinclus Pharma. “We are particularly excited given Zentiva’s commercial reach and operational strength across Europe. This alliance establishes a fully integrated set of capabilities covering everything necessary to bring linaprazan glurate to the market across Europe. The alliance benefits from world-leading expertise in gastroenterology-focused development, regulatory affairs, manufacturing and commercialization. This collaboration not only de-risks our path to European approval but also positions us to capture significant global value, particularly in the US market where we retain full commercial rights and see a substantial commercial opportunity” “This partnership marks a key milestone for Zentiva as we continue expanding our portfolio beyond generics into high-value specialty medicines. Linaprazan glurate is a complementary asset that perfectly fits our strategy to leverage our excellence in generics and deliver game-changing treatments to patients across Europe. With our strong pan-European commercial platform, we are proud to be the trusted partner to bring this innovative therapy to those suffering from severe erosive GERD” said Martin Albert, CSO, Zentiva. About Zentiva Zentiva provides health and wellbeing for all generations. It is a European company developing, producing, and delivering high-quality, affordable medicines to more than 100 million people in over 30 countries across Europe and beyond. Zentiva has four wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. The company is private equity-owned, delivering sustainable growth, with an ambitious plan for the years to come. Invitation to webcast 09.00 CEST The company will host a webcast today at 09:00 am CEST with a presentation and a Q&A session. If you wish to participate via webcast please use the link below. Via the webcast you are able to ask written questions. https://live.events.inderes.com/press-conference-may-22 If you wish to participate via teleconference please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference. https://events.inderes.com/live/press-conference-may-22/dial-in For additional information, please contact: Christer Ahlberg, CEO Phone: +46 70 675 33 30 e-mail: christer.ahlberg@cincluspharma.com Henrik Vikström, IR Phone: +46 70 952 80 06 e-mail: henrik.vikström@cincluspharma.com About Cinclus Pharma Cinclus Pharma Holding AB (publ) is a late-stage clinical pharmaceutical company developing drugs for the treatment of acid-related diseases and disorders of the upper gastrointestinal tract. The company's leading drug candidate is linaprazan glurate, a prodrug of P-CAB linaprazan, which was originally developed by AstraZeneca. Linaprazan glurate has the potential to heal erosions in the esophageal mucosa and relieve symptoms of gastroesophageal reflux disease (GERD) more effectively than current treatments like proton pump inhibitors (PPI). The safety and efficacy of linaprazan and linaprazan glurate have been documented in over 30 phase I and two phase II studies involving more than 3,000 participants. Planning for phase III studies is currently underway, with an expected start in 2025. GERD affects approximately 133 million adults in the US and EU, and there is a significant need for new drugs to treat the most severe cases: around 10 million patients. Linaprazan glurate is developed to meet these needs. For more information, visit www.cincluspharma.com. This information is information that Cinclus Pharma Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-05-22 07:30 CEST. Attachments Cinclus Pharma Partners with Zentiva to Commercialize Linaprazan Glurate in Europe

引进/卖出临床2期临床3期

2025-04-17

·摩熵医药

P-CAB市场三强争霸！科伦、扬子江等56家药企竞逐伏诺拉生仿制

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。新型抑酸药——钾离子竞争性酸阻滞剂(P-CAB)领域，武田的伏诺拉生以7.3亿元销售额领跑，罗欣药业的替戈拉生、柯菲平医药的凯普拉生紧随其后，三者均通过医保加速放量。仿制药企业如新时代药业、科伦药业已布局伏诺拉生首仿，2026年专利到期后市场或迎井喷。此外，上海医药的信诺拉生、扬子江的非苏拉生即将上市，P-CAB研发持续升温。然而，长期抑酸导致的感染、骨质疏松等风险仍需关注。本文基于摩熵咨询《H2受体阻滞剂K＋竞争性酸阻滞剂市场专题研究报告》，聚焦钾离子竞争性酸阻滞剂药物市场格局、企业策略与政策影响，解析未来竞争趋势。 01钾离子竞争性酸阻滞剂竞争格局：三足鼎立局面已形成截至2024年11月，我国已上市3款钾离子竞争性酸阻滞剂，分别是武田的伏诺拉生、罗欣药业的替戈拉生和柯菲平医药的凯普拉生。伏诺拉生是由武田制药研发，于2014年12月在日本获批上市，用于治疗胃溃疡、十二指肠溃、根除幽门螺旋杆菌、小剂量阿司匹林给药期间预防胃溃疡或十二指肠溃疡复发。2019年12月获批进入中国市场用于治疗反流性食管炎，其后在2023年11月获批与适当的抗菌药物联用以根除幽门螺杆菌。替戈拉生是罗欣药业与韩国HKinno.NCorporation通过合作协议，获得在中国境内独家研发、生产及商业化权益。2022年4月获批上市，用于治疗反流性食管炎。2023年11月获批用于十二指肠溃病，2024年获批与适当的抗菌药物联用以根除幽门螺杆菌。是我国首个获批三个适应症的钾离子竞争性酸阻滞剂。凯普拉生片是由柯菲平医药研发并由复兴医药独家商业化，2023年2月获批上市，用于十二指肠溃疡和反流性食管炎，又于2024年11月获批与适当的抗菌药物联用以根除幽门螺杆菌，是我国首款自主研发的钾离子竞争性酸阻滞剂。数据来源：摩熵医药数据库根据摩熵医药数据库统计显示，截至2024年11月，三款药物均已进入医保，处于放量阶段。富马酸伏诺拉生2020年通过谈判进入国家医保乙类目录（限反流性食管炎的患者），受益于医保放量，伏诺拉生销售额由2020年0.14亿元快速增长至2023年7.3亿元，年复合增长率达273.1%。替戈拉生片在2022年通过谈判进入国家医保乙类目录（限：1.十二指肠溃疡；2.反流性食管炎），销售额也在2023年突破1亿元。图片来源：摩熵咨询《H2受体阻滞剂K+竞争性酸阻滞剂市场研究专题报告》盐酸凯普拉生片在2023年通过谈判进入国家医保乙类目录（限反流性食管炎），长期放量值得期待。02伏诺拉生：国产仿制钾离子竞争性酸阻滞剂蓄势待发富马酸伏诺拉生的化合物专利预计于2026年8月29日到期，遵循专利法规定，仿制药市场需静待原研药专利失效。但各大领先药企早已未雨绸缪，新时代药业在2022年7月便捷足先登，夺得首仿桂冠，随后科伦药业、海汇药业、华森制药等企业紧跟步伐，市场迅速形成了“1+7”的竞争格局。此外，永太药业、康恩贝制药、万高药业等56家企业正翘首以待其产品上市审批的结果，而新华制药、北陆制药、白鹿药业等37家企业也已完成或正积极申报临床阶段，整个市场蓄势待发，竞争态势愈发紧张。图片来源：摩熵咨询《H2受体阻滞剂K+竞争性酸阻滞剂市场研究专题报告》03治疗与胃酸分泌相关疾病的药物市场趋势分析01钾离子竞争性酸阻滞剂创新药研发加速截至2024年11月，除了已上市的伏诺拉生、替戈拉生和凯普拉生外，还有两款钾离子竞争性酸阻滞剂即将上市，分别为上海医药的信诺拉生和扬子江的非苏拉生。2021年10月上海医药与贵州生诺生物及其全资子公司太瑞生诺签订《合作协议》，以不超过6.9亿元（除销售提成外）的交易金额取得X842项目（即信诺拉生酯胶囊）原料药及制剂在中国区域（包括中国香港、澳门及台湾地区）的独家委托生产和所有适应症的工业销售权。信诺拉生酯胶囊也于2023年2月申报上市，申报适应症为反流性食管炎。2023年6月，大熊制药与扬子江药业共同递交盐酸非苏拉生片的上市申请。盐酸非苏拉生片是大熊制药研发的一款新型钾离子竞争性酸阻滞剂类药物，扬子江药业及旗下海尼药业通过一项超20亿元的合作获得了其在中国的开发和销售权利。02长期应用抑酸剂带来的不良反应有待攻克抑酸剂出现为消化科治疗酸相关疾病带来革命性改变，但很多时候抑酸剂被用于了非适应症的患者。越来越多的研究报告抑酸制剂相关不良反应。抑酸剂相关不良反应最常见的是感染。其中的原因很好理解，即胃酸是我们胃内抵御外来微生物侵袭的第一道防线，当我们使用抑酸剂抑酸时，我们也就同时失去了胃内一线防御功能，无法抵御微生物的侵袭，经口摄入的微生物就会进入胃肠道从而引发感染。大量研究已经验证了抑酸剂与感染间的相关性。此外，也有研究报道了，抑酸剂长期应用导致的社区获得性肺炎或骨质疏松，以及代谢性疾病（例如：糖尿病），还有痴呆症。小结P-CAB领域，伏诺拉生、替戈拉生、凯普拉生均已纳入医保，伏诺拉生年复合增长率达273.1%，2023年销售额7.3亿元。武田原研药专利2026年到期，新时代药业等56家药企蓄势仿制，市场竞争白热化。信诺拉生、非苏拉生等新药即将上市，未来P-CAB赛道或迎爆发式增长，但长期抑酸的不良反应仍需攻克。END本文为原创文章，转载请留言获取授权H2受体阻滞剂钾离子竞争性酸阻滞剂市场研究专题报告完整报告领取方式近期热门资源获取CGT产业现状与未来趋势蓝皮书-202406中药行业现状与未来趋势白皮书-2024072023年医药企业综合实力排行榜-202408跨越国界，引领创新：中国药企出海的布局实践-202408专利即将到期五大重磅小分子药品，国内仿制药“战况”几何?-202409中国放射性药物市场现状分析报告-202410合成生物产业发展前景及中国合成生物产业链上中下游企业分析-202410中国合成生物学创投市场分析报告-202410中国糖尿病临床诊疗与药物多渠道市场数据分析-202411基于剂型改良的复杂注射剂分析--微球篇-2024112024医美注射材料市场发展分析报告-20241213国家药品集采跟踪报告-前9批次集采回顾与展望-202411近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

专利到期上市批准

100 项与戊二酸利那拉生酯相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
反流性食管炎	中国	上海生诺医药科技有限公司	2024-12-01

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
糜烂性食管炎	临床2期	美国	Cinclus Pharma AG	2021-08-11
糜烂性食管炎	临床2期	保加利亚	Cinclus Pharma AG	2021-08-11
糜烂性食管炎	临床2期	捷克	Cinclus Pharma AG	2021-08-11
糜烂性食管炎	临床2期	格鲁吉亚	Cinclus Pharma AG	2021-08-11
糜烂性食管炎	临床2期	匈牙利	Cinclus Pharma AG	2021-08-11
糜烂性食管炎	临床2期	波兰	Cinclus Pharma AG	2021-08-11
糜烂性食管炎	临床2期	塞尔维亚	Cinclus Pharma AG	2021-08-11
糜烂性食管炎	临床2期	乌克兰	Cinclus Pharma AG	2021-08-11
胃食管反流	临床2期	欧盟	Cinclus Pharma AG	2020-01-22
十二指肠溃疡	临床2期	中国	江苏太瑞生诺生物医药科技有限公司	-

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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


NCT05742984 (CTgov)	临床1期	胃食管反流	75	Linaprazan Glurate (25 mg Linaprazan Glurate QD)	鑰遞鏇獵鏇遞蓋獵鑰鏇(衊夢夢壓鹹窪鏇獵積鬱) = 鬱壓蓋鹹觸餘構膚鑰淵繭醖齋鹽範範鹹鹽夢築 (襯醖鑰構鹽獵鹽窪廠築, 1650.6) 更多	-	2025-05-07
				Linaprazan Glurate (50 mg Linaprazan Glurate QD)	鑰遞鏇獵鏇遞蓋獵鑰鏇(衊夢夢壓鹹窪鏇獵積鬱) = 醖蓋餘蓋選壓築艱淵獵繭醖齋鹽範範鹹鹽夢築 (襯醖鑰構鹽獵鹽窪廠築, 2281.0) 更多
NCT05055128 (Pubmed \| Aliment Pharmacol Ther) 人工标引	临床2期	糜烂性食管炎	248	Linaprazan Glurate	鑰選製艱膚廠憲遞構醖(膚醖憲簾蓋壓願願襯選) = 鬱遞鏇鹹窪夢獵築構積築糧積鑰醖憲繭窪獵繭 (夢淵製遞鹹構網繭鹹鏇 ) 更多	积极	2025-04-04
				Lansoprazole	鑰選製艱膚廠憲遞構醖(膚醖憲簾蓋壓願願襯選) = 鹹醖廠夢齋糧鹹繭廠憲築糧積鑰醖憲繭窪獵繭 (夢淵製遞鹹構網繭鹹鏇 ) 更多
NCT04531475 (Phase 2 study, Pubmed \| Clin Transl Gastroenterol)	临床2期	糜烂性食管炎	90	X842 50 mg	鬱觸齋顧遞襯艱壓窪齋(鏇顧觸衊醖觸憲鹽膚餘) = The incidence of drug-related treatment-emergent adverse events did not differ among groups 鑰繭糧齋憲顧醖遞鏇夢 (網顧餘願夢夢願淵選願 ) 更多	积极	2025-04-01
				X842 100 mg
NCT05633147 (CTgov)	临床1期	药物相互作用	35	Linaprazan glurate+Clarithromycin (Part I)	夢願糧餘憲壓餘鑰範鏇(淵夢廠膚衊鏇蓋觸鏇選) = 廠廠構製廠積鬱壓壓鬱繭壓製鏇淵遞選餘製鑰 (鹹襯醖廠醖醖襯窪獵鹽, 5649) 更多	-	2025-01-03
				Midazolam+Linaprazan glurate hydrochloride (HCl) (Part II)	餘鏇鹽觸糧鬱顧網壓製(構顧醖憲夢蓋積鹹憲壓) = 選淵構製積壓鏇獵餘鏇鏇壓廠顧範艱簾鑰齋獵 (獵壓餘窪鹽網鏇膚網淵, 13.98) 更多
UEGW2024	N/A	-	-	25 mg LG QD	構鹽鑰衊憲積醖鏇壓淵(簾衊夢積憲廠繭築窪願) = headache 構範齋淵獵艱構憲遞繭 (鑰壓憲選鑰膚範鹽構繭 ) 更多	-	2024-10-13
				50 mg LG QD
DDW2024	N/A	-	-	Vonoprazan-based triple therapy	鹽簾製鑰壓窪願獵糧製(觸襯糧衊鬱淵蓋糧鹽膚): RR = 1.17 (95% CI, 1.11 ~ 1.22)	-	2024-05-18
				Conventional PPI-based triple therapy
NCT05055128 (CTgov)	临床2期	糜烂性食管炎 \| 胃食管反流	248	Lansoprazole+X842 Dummy (X842 25 mg BID)	築鬱鹽鏇廠觸襯壓艱蓋 = 鑰壓憲鹹壓顧窪構蓋觸蓋憲襯簾製襯願積壓壓 (夢鏇衊觸襯糧鹽糧鹽憲, 鬱壓膚鏇憲網壓廠壓範 ~ 選餘艱鹽網蓋遞襯積夢) 更多	-	2023-11-01
				Lansoprazole+X842 Dummy (X842 50 mg BID)	築鬱鹽鏇廠觸襯壓艱蓋 = 網顧築鬱築範鑰齋鑰醖蓋憲襯簾製襯願積壓壓 (夢鏇衊觸襯糧鹽糧鹽憲, 壓蓋範壓憲蓋繭鹽憲製 ~ 顧蓋選蓋廠簾艱壓淵願) 更多