Ph 1, OL, Randomized, Parallel-group Study to Investigate PK and PD (Intragastric pH) of Linaprazan Glurate/Linaprazan After 14 Days 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), safety and tolerability of single and repeated oral doses of Linaprazan Glurate for up to 14 days at 3 dose levels in 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）

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 ; Zheng, Yuandong ; Yuan, Yali ; 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.

2023-02-01·Archives of microbiology

Formulation-based antagonistic endophyte Amycolatopsis sp. SND-1 triggers defense response in Vigna radiata (L.) R. Wilczek. (Mung bean) against Cercospora leaf spot disease

Article

作者: Kumar, Raju Suresh ; Nayaka, Sreenivasa ; Basavarajappa, Dhanyakumara Shivapoojar

In the present work, Amycolatopsis sp. SND-1 (SND-1) was isolated from Cleome chellidonii Linn. (C. chellidonii) was performed as biocontrol and resistance elicitor in Vigna radiata (L.) R. Wilczek (mung bean) plants against Cercospora leaf spot causing pathogen Cercospora canescens (C. canescens). The SND-1 isolate showed 74% of inhibition against C. canescens in dual culture and GC-MS analysis revealed the presence of antifungal compounds. Molecular characterization through 16S rRNA showed that the isolated SND-1 belongs to Amycolatopsis sp. The in vitro plant growth trials exhibited production of indole acetic acid, gibberellic acid, cytokinin, ammonia, hydrogen cyanide, and siderophore and phosphate solubilization. In vivo study with talcum formulation of SND-1 revealed a significant increase in plant root length, shoots length, root and shoot fresh weight, and reduced the disease severity in treated mung bean plants. Triggering of resistance by SND-1 formulation was studied by histochemical depositions and biochemical defense enzymes that resulted in the acceleration in defense response in comparison with control plants. The bioactive endophytic Amycolatopsis sp. SND-1 enhanced the defense against C. canescens infection; hence, it can be used as a biological control agent in mung bean cultivars.

项与戊二酸利那拉生酯相关的新闻（医药）

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.libproxy1.nus.edu.sg/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

2025-03-19

·精准药物

Biotech从野蛮生长到理性收缩

作者｜momo 过去十年，Biotech在资本狂欢与技术突破的驱动下，曾以惊人的速度野蛮生长：PD-1单抗扎堆逾百家、TIGIT靶点竞逐、ADC赛道狂热，无数企业涌入同质化赛道，掀起了一场激烈的创新竞赛。然而，当资本退潮、政策趋严、临床试验失败率攀升，Biotech被迫直面“创新效率”的拷问。曾经的“靶点内卷”让位于差异化创新，冗余管线被“精准瘦身”，高风险领域遭遇战略性撤退，标志着行业从“野蛮生长”转向“理性收缩”。 01 中国药企从“烧钱内卷”到“精准狙击” 2024年，国内创新药企掀起一波研发管线终止，折射出行业深层次的结构性挑战。上海医药以近7亿元代价砍掉12项管线，包括因PD-1市场过度竞争而终止的III期宫颈癌药物BCD-100，以及研发进度滞后的类风湿关节炎II期项目I008（图1），这两款药物的累计研发投入分别为5900.80万元和6218.75万元。图1.上海医药终止BCD-100、I008等项目公告数据来源：上海医药官网过去20年间，上海医药累计研发投入超200亿元。高额投入的背后，却是严重不对等的研发成果，上海医药至今只有花费6.9亿元从生诺医药引进的一款抑酸新药信诺拉生酯胶囊（X842）获批上市。 2024年，中国Biotech在资本狂欢褪去后迎来“理性收缩”元年，多家药企掀起研发管线“砍单潮”。天坛生物则因市场情况终止其子公司蓉生药业的“静注巨细胞病毒人免疫球蛋白(ph4)”III期临床试验研究及后续研发。据悉，该公司在这个药物研发上已投入7069.09万元；不谋而合的是，舒泰神也基于新冠市场形势终止了累计研发投入3.83亿元的BDB-001注射液、STSA-1002注射液、STSA-1005注射液等多个项目在COVID-19适应症方向的研究工作。百济神州则战略性终止了与Shoreline Biociences公司的异基因NK细胞疗法合作项目，专注开发自研的细胞治疗产品；类似地，华东医药也放弃疗效逊于HDM1002的口服GLP-1药物TTP273，转向自研潜力产品HDM1002、HDM1005（图2）。图2.华东医药终止TTP273项目公告数据来源：华东医药官网此外，中国Biotech迎来研发寒冬，多家药企因临床试验失败或安全性问题终止核心管线。亚虹医药因APL-1202联合化疗未达主要终点，终止累计投入1.3亿元的核心管线。事实上，亚虹医药已连续多年深陷亏损泥沼，2018年至2023年期间合计净亏损约为15.45亿元；此外，亚宝药业也因II型糖尿病药物SY-004的临床研究未达良好预期而被暂停；宜联生物HER3 ADC（YL202/BNT326）更因临床试验中3例患者死亡遭遇FDA部分叫停，好在已经恢复临床试验。 2024年国内终止项目数量激增，超70%集中在肿瘤及代谢疾病（GLP-1）等同质化赛道，PD-1单抗上市数量远超海外，导致资源严重冗余。中国医药行业正经历从“野蛮生长”到“理性收缩”的阵痛期，企业加速“早期管线止损”，通过聚焦差异化创新重塑竞争力，这场研发寒冬或将成为中国创新药从“量变”到“质变”的分水岭。 02 跨国药企从“广撒网”到“精耕细作” 跨国药企加速研发战略转型，聚焦肿瘤、免疫及神经科学领域高潜力赛道，通过终止或调整临床项目实现资源优化配置，既凸显行业对研发效率的极致追求，亦暴露靶点选择与临床验证的深层风险性。在肿瘤治疗领域，TIGIT靶点研发的集体受挫成为行业焦点。 2023年BMS宣布终止其自研的TIGIT单抗BMS-986207的II期临床试验。同年8月，BMS又退货了Agenus的TIGIT/CD96双抗管线，这意味着其彻底放弃TIGIT靶点；无独有偶，2024年7月，罗氏也终止了TIGIT抗体RG6058的III期临床开发，该产品曾被寄予厚望作为PD-(L)1联合疗法的下一代搭档；图3.罗氏管线调整数据来源：罗氏2024年财报此外，2024年12月，默沙东也因临床数据不足放弃了抗TIGIT抗体vibostolimab的联合疗法开发。这一系列动作使得TIGIT成为继CTLA-4之后又一“折戟沉沙”的免疫检查点靶标，其作用机制和患者筛选标准面临重新审视。与此同时，BMS对肿瘤领域其他靶点药物也展开了大刀阔斧的战略调整。 2024年第二季度，BMS宣布终止CD3/BCMA双抗Alnuctamab的III期开发，尽管该产品在2024年5月刚启动临床试验，但面对再生元Linvoseltamab的上市申请和艾伯维TNB-383B的III期推进，BMS选择战略性退出竞争白热化的BCMA双抗双抗赛道，转而巩固其在CAR-T疗法领域的领先地位。此外，神经退行性疾病领域的高风险性也再次得到验证。罗氏终止了阿尔茨海默病抗Tau单抗bepranemab的开发，这已是该领域近三年内第7个终止的III期项目，凸显β淀粉样蛋白和Tau蛋白假说在临床转化中的困境。阿斯利康则砍掉LOX-1单抗MEDI6570，进一步收缩在脑血管疾病领域的布局。这些调整推动企业将目光转向确定性更高的代谢疾病领域，辉瑞虽因副作用终止GLP-1RA项目洛替列酮，但诺和诺德、礼来在减肥药市场的成功仍吸引着行业持续加码。值得注意的是，在技术平台选择上，ADC和核药成为战略转型的核心方向。吉利德彻底退出CD47赛道，将magrolimab所有研究终止后，转而通过收购扩充肿瘤免疫管线。这种“砍旧立新”的策略在艾伯维身上尤为明显，其在2023年终止了与CytomX Therapeutics关于CX-2029（条件激活CD71 ADC）的合作，并在2024年继续连续终止ABBV-154等3个ADC项目，却在2024年完成对ADC龙头公司的并购，展现“选择性收缩”与“战略性扩张”并行的独特策略。在生物医药创新的新纪元，“少而精”的精准投入正在取代“广撒网”的传统模式，这场静悄悄的革命或将重塑全球制药产业的竞争格局。结语全球Biotech行业正从资本驱动的“野蛮生长”转向科学驱动的“理性收缩”。资本退潮、政策趋严与临床试验失败频发，迫使企业重新审视研发策略，聚焦高潜力赛道与技术平台。这意味着持续深耕差异化创新的企业，终将在行业洗牌中脱颖而出。此外，ADC、双抗、核药等新兴技术平台成为行业转型的核心驱动力，而国际化战略则是企业突破市场瓶颈的必由之路。中国Biotech企业通过出海授权与自建团队加速全球化布局，头部企业如百济神州、信达生物已崭露头角，但中小企业仍需在资金与商业化能力上寻求突破。全球Biotech面对行业分化加剧，短期阵痛不可避免，但长期来看，坚守科学本质与战略定力的企业将赢得未来。无论是跨国巨头还是本土创新者，只有聚焦未被满足的临床需求、开发同类最优药物，才能在“理性收缩”的寒冬中实现从量变到质变的跨越，引领全球Biotech行业迈向新纪元。参考资料 [1]各大企业官网、官微、财报、公告及公开资料声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

临床3期财报抗体药物偶联物临床2期细胞疗法

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

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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初创企业	2021-08-11
糜烂性食管炎	临床2期	保加利亚	Cinclus Pharma AG初创企业	2021-08-11
糜烂性食管炎	临床2期	捷克	Cinclus Pharma AG初创企业	2021-08-11
糜烂性食管炎	临床2期	格鲁吉亚	Cinclus Pharma AG初创企业	2021-08-11
糜烂性食管炎	临床2期	匈牙利	Cinclus Pharma AG初创企业	2021-08-11
糜烂性食管炎	临床2期	波兰	Cinclus Pharma AG初创企业	2021-08-11
糜烂性食管炎	临床2期	塞尔维亚	Cinclus Pharma AG初创企业	2021-08-11
糜烂性食管炎	临床2期	乌克兰	Cinclus Pharma AG初创企业	2021-08-11
胃食管反流	临床2期	欧盟	Cinclus Pharma AG初创企业	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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适应症

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


NCT05055128 (Pubmed \| Aliment Pharmacol Ther) 人工标引	临床2期	糜烂性食管炎	248	Linaprazan Glurate	夢夢繭齋憲鹽艱餘窪鏇(壓窪範網壓廠簾醖壓觸) = 憲廠鬱構淵憲壓襯壓築醖艱衊糧壓獵製築範鏇 (構獵醖齋鏇醖窪簾構餘 ) 更多	积极	2025-04-04
				Lansoprazole	夢夢繭齋憲鹽艱餘窪鏇(壓窪範網壓廠簾醖壓觸) = 蓋窪醖襯壓網鬱憲蓋鹹醖艱衊糧壓獵製築範鏇 (構獵醖齋鏇醖窪簾構餘 ) 更多
NCT04531475 (Phase 2 study, Pubmed \| Clin Transl Gastroenterol)	临床2期	糜烂性食管炎	90	X842 50 mg	鬱網鏇艱構願憲獵襯襯(膚醖醖範淵範淵簾構廠) = The incidence of drug-related treatment-emergent adverse events did not differ among groups 繭鏇繭壓齋淵顧鏇糧築 (構餘鹹憲獵窪蓋顧窪壓 ) 更多	积极	2025-01-21
				X842 100 mg
NCT05633147 (CTgov)	临床1期	药物相互作用	35	Linaprazan glurate+Clarithromycin (Part I)	鹽夢網衊遞鏇淵選壓構(繭衊窪餘壓積範艱淵膚) = 齋選膚鑰遞選壓鹽襯繭艱製獵糧遞憲醖構齋積 (醖築鏇鑰糧鑰齋夢餘壓, 5649) 更多	-	2025-01-03
				Midazolam+Linaprazan glurate hydrochloride (HCl) (Part II)	襯願選構築鹹艱艱獵構(築餘範餘餘構齋窪蓋糧) = 範鹽鹹選範襯鹽製顧鹹鑰鑰製簾鑰獵鑰淵夢鏇 (獵製獵鹽製製淵窪廠廠, 13.98) 更多
DDW2024	N/A	-	-	Vonoprazan-based triple therapy	膚憲醖範選觸窪構艱製(獵網糧夢鹽積醖觸艱範): 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)	積鑰獵獵夢壓鏇築顧遞 = 鬱鏇範鬱簾繭鹽淵網鹽衊淵網糧範壓積艱簾繭 (夢艱鏇鑰繭鹽窪願獵選, 蓋顧顧範夢膚遞膚壓鏇 ~ 餘簾願選願膚構衊鬱膚) 更多	-	2023-11-01
				Lansoprazole+X842 Dummy (X842 50 mg BID)	積鑰獵獵夢壓鏇築顧遞 = 願齋餘網艱鑰網廠鏇鹹衊淵網糧範壓積艱簾繭 (夢艱鏇鑰繭鹽窪願獵選, 簾積築夢鏇鏇糧衊繭製 ~ 願膚顧齋範鹹襯廠醖窪) 更多