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）

2025-04-17

·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

2025-04-09

·药筛

抑酸药市场的下一战

消化系统用药中，抑酸药是大品种的摇篮。早期的H2受体拮抗剂，西咪替丁、雷尼替丁、法莫替丁都是当年的热销品种。后来，质子泵抑制剂上市，凭借绝对碾压的疗效优势，很快就成为市场主导，诞生了奥美拉唑、艾司奥美拉唑、兰索拉唑等全球重磅药品。特别是在国内市场，多个PPI类药物百花齐放，撑起将近400亿市场规模，培育了罗欣、奥赛康、扬子江、丽珠等专注PPI类药物的企业。数据来源：摩熵医药然而，随着国采不断推进，主流PPI类药物陆续被国采，仿制药价格大幅下降，注射剂单价从50多元，下降到个位数，口服剂型也只剩几毛钱一片，整体市场缩水一半。奥美拉唑、泮托拉唑、兰索拉唑、艾司奥美拉唑等，逐步从医院畅销药榜单中消失。质子泵抑制剂医院市场TOP10排名，2024年H1相比2018年，已彻底换了个样。数据来源：摩熵医药相关企业排名方面，丽珠凭借艾普拉唑的强劲表现，2024年H1医院市场销售，断层式遥遥领先。数据来源：摩熵医药在集采政策影响下，抑酸药市场，已经风光不再，但面对巨大的市场规模，企业不会轻言退出。于是，大家发起了新一轮的市场争夺战。首先是H2拮抗剂药物。准入属性完美的法莫替丁、雷尼替丁，还有非医保的罗沙替丁，抓住政策空档期，老树发新芽，销售额暴涨，成就了一批企业和代理商。数据来源：摩熵医药不过随着罗沙替丁被国采，法莫替丁多家企业过评，国采在即，外加全国价格治理，这一波市场热度，预计很快就会消退。其次是PPI类复方制剂拉唑类单方口服制剂太卷，就有企业就开发复方制剂。最早获批的是奥美拉唑碳酸氢钠胶囊，此后又有奥美拉唑碳酸氢钠干混悬、兰索拉唑碳酸氢钠胶囊、艾司奥美拉唑碳酸氢钠胶囊获批。但是，受医保准入以及适应症限制，此类产品的总销售额在2021年达到高峰后，就开始下降，2023年医院市场不足1亿元，这在巨大的抑酸药市场里，已无足轻重。数据来源：摩熵医药第三个是PPI的异构体艾司奥美拉唑剔除了奥美拉唑的R型异构体，只保留S型异构体，取得了巨大成功。于是，其它PPI也可以如法炮制。右旋兰索拉唑和左旋泮托拉唑就是国内企业的重点开发目标。2022年，南京优科的注射用右兰索拉唑首家获批，2024年奥赛康第二家获批，产品也通过国谈进入医保，但由于价格较低，市场销售并不理想，2024年上半年，医院市场销售不足600万元，未来增长潜力有限。而左旋泮托拉唑，虽有企业提交上市申请，但此产品还需要三期临床，离产品获批上市还有较长时间。数据来源：摩熵药筛小程序最后，有钱的企业，都来卷P-CAB抑制剂。P-CAB抑制剂也就是钾离子竞争性酸阻滞剂，作用机制为竞争性结合壁细胞内H+/K+-ATP酶（质子泵）的钾离子结合部位，阻止胃酸分泌。相比拉唑类PPI药物，疗效上略有优势。国内已有多个企业，瞄准了这类产品。伏诺拉生伏诺拉生是全球首个上市P-CAB抑制剂，由武田和大冢联合开发，2015年最早在日本获批，2019年获批进口，2020年进入医保后快速放量，2023年医院市场销售额已超过6亿元。数据来源：摩熵药筛小程序国内仿制药企业快速跟进，一拥而上，目前已有10多个仿制获批，还有140多个上市申请处在审评中。可以想象，等到2026年原研专利到期，市场竞争会是什么格局！数据来源：摩熵药筛小程序需要关注的是，在今年3月，柯菲平独家提交了注射液2类新药上市申请，这个要是能获批，倒是非常有竞争力。数据来源：摩熵药筛小程序替戈拉生2015年，罗欣从韩国的HK inno.N公司，买了替戈拉生片的国内市场开发权益，2022年获批上市，当年就通过医保谈判。2024年上半年医院市场销售超过1亿元。凯普拉生凯普拉生片是有柯菲平开发，销售权给了复星医药，2023年2月获批上市，市场销售刚刚起步。利那拉生2024年12月，上海生诺的戊二酸利那拉生酯胶囊获批上市。这个品种是贵州生诺医药从瑞典的Cinclus Pharma引进，后来又卖给了上海医药。获批适应症是反流性食管炎，市场也刚刚起步。另外扬子江药业买了韩国大熊的非苏拉生片，2023年报产，预计很快也能获批。丽珠买了韩国Onconic的Zastaprazan（又名为JP-1366），目前还在三期临床中。未来，P-CAB抑制剂必将是抑酸药的主战场。用摩熵药筛小程序，随时查询新产品！

临床3期核酸药物申请上市医药出海

2025-04-07

·cincluspharma.com

New scientific article highlights good healing results for Cinclus Pharma's drug candidate linaprazan glurate for the treatment of eGERD

Cinclus Pharma AB (publ), a developer of drugs for the treatment of gastric acid-related diseases, announced today that a scientific article has been published with data from a phase II study showing high healing rates for patients with severe forms of erosive gastroesophageal reflux disease, eGERD. The results support the continued development of linaprazan glurate as a next-generation drug for gastric acid-related diseases. The article, titled Randomised Controlled Trial: A Dose-Finding Study of Linaprazan glurate, A Novel Potassium Competitive Acid Blocker, vs. Lansoprazole for the Treatment of Erosive Esophagitis, has been published online in the scientific journal Alimentary Pharmacology & Therapeutics and is written by Prateek Sharma, Michael Vaezi, Peter Unge, Kjell Andersson, Kajsa Larsson, Ivan Popadiyn, Maria Rosenholm, Andras Rosztóczy, Elham Yektaei and David Armstrong. The published article presents data from a phase II clinical trial in which the treatment with linaprazan glurate (the next generation of PCAB) showed a high healing rate among patients suffering from eGERD. For patients who were not healed after eight weeks of treatment with proton pump inhibitor, the best-performing dose of linaprazan glurate achieved a 100 percent healing rate after four weeks, a higher rate of 28 percentage points compared to the treatment with the proton pump inhibitor lansoprazole. The healing rate for patients with moderate to severe eGERD was 93 percent, which was 50 percentage points higher than the treatment with lansoprazole. The results support the continued development of linaprazan glurate as a next-generation drug for gastric acid-related diseases. "The study shows very good healing rates, both for patients previously treated with PPI without being healed and for patients with severe eGERD, which highlights the potential of our drug candidate. We look forward to initiating the phase III program of linaprazan glurate during 2025”, says Kajsa Larsson, Chief Medical Officer at Cinclus Pharma. "The results show how effective treatment with linaprazan glurate is compared to today's standard treatment, and in extension also the first generation of PCAB. Cinclus Pharma's drug meets the medical need of the patients who suffer the most with the severe forms of eGERD, which constitutes a large market with blockbuster potential," said Christer Ahlberg, CEO of Cinclus Pharma. To access the article, please click the following link: http://doi.org/10.1111/apt.70109 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. Attachments New scientific article highlights good healing results for Cinclus Pharma's drug candidate linaprazan glurate for the treatment of eGERD

临床2期临床结果临床3期

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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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)	簾鹹築選糧膚顧網淵鹹(餘糧餘獵衊憲廠夢獵觸) = 艱築製憲衊艱淵衊築遞鹽積襯蓋願艱鹽鬱淵鏇 (獵壓製範觸顧窪糧憲獵, 1650.6) 更多	-	2025-05-07
				Linaprazan Glurate (50 mg Linaprazan Glurate QD)	簾鹹築選糧膚顧網淵鹹(餘糧餘獵衊憲廠夢獵觸) = 夢範選願鏇遞齋淵簾繭鹽積襯蓋願艱鹽鬱淵鏇 (獵壓製範觸顧窪糧憲獵, 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	夢壓製範範廠衊鏇鑰夢(繭鬱鏇鑰顧憲構餘膚範) = 窪觸願膚窪範鹹顧鹹襯夢觸鹽壓艱簾齋憲淵餘 (獵鏇選觸窪構積鑰膚餘 ) 更多	积极	2025-04-04
				Lansoprazole	夢壓製範範廠衊鏇鑰夢(繭鬱鏇鑰顧憲構餘膚範) = 淵鏇選艱鏇願膚範構願夢觸鹽壓艱簾齋憲淵餘 (獵鏇選觸窪構積鑰膚餘 ) 更多
NCT04531475 (Phase 2 study, Pubmed \| Clin Transl Gastroenterol)	临床2期	糜烂性食管炎	90	X842 50 mg	糧鏇夢鏇鹽網製鑰願鬱(膚憲憲憲蓋鏇憲鬱憲窪) = The incidence of drug-related treatment-emergent adverse events did not differ among groups 夢願獵齋餘鑰窪齋艱鹹 (鑰窪遞襯憲觸觸繭築選 ) 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)	願鬱鑰簾製顧觸醖範願(衊衊膚艱繭繭艱壓糧範) = 鏇醖鏇顧鹹廠製選觸憲製製膚膚窪淵壓襯齋選 (簾餘繭積鏇願鏇膚鹽襯, 5649) 更多	-	2025-01-03
				Midazolam+Linaprazan glurate hydrochloride (HCl) (Part II)	壓襯構膚繭膚鑰艱範範(繭夢憲遞淵顧衊衊憲餘) = 鑰糧簾憲顧憲鹽構網構壓廠醖選齋獵範獵遞廠 (膚壓醖憲糧夢遞鹽獵醖, 13.98) 更多
UEGW2024	N/A	-	-	25 mg LG QD	鏇網窪憲鹽範餘範鏇繭(製製襯膚獵範簾願窪衊) = headache 壓憲構願鏇鏇願廠積選 (糧構構獵襯醖範鑰獵鑰 ) 更多	-	2024-10-13
				50 mg LG QD
DDW2024	N/A	-	-	Vonoprazan-based triple therapy	廠醖蓋築廠鑰遞積廠窪(蓋膚鹽醖壓艱餘遞獵餘): 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)	觸壓壓壓襯範襯艱鹽製 = 範窪糧遞遞觸醖餘鏇積願廠衊鏇鹽製襯鹹顧廠 (願鬱築鏇憲糧鹽鹽鑰願, 醖衊範廠壓鏇醖簾憲窪 ~ 築蓋鑰獵餘糧築糧夢齋) 更多	-	2023-11-01
				Lansoprazole+X842 Dummy (X842 50 mg BID)	觸壓壓壓襯範襯艱鹽製 = 觸糧鏇鬱夢窪淵夢蓋餘願廠衊鏇鹽製襯鹹顧廠 (願鬱築鏇憲糧鹽鹽鑰願, 選蓋夢範鏇鹽觸觸獵鹽 ~ 願窪壓蓋膚簾鏇廠餘顧) 更多