A Randomized, Phase 3, Double-blind, Double-dummy, Active Comparator-controlled Multicenter Study to Evaluate the Efficacy and Safety of 2 Doses of Linaprazan Glurate Compared to Lansoprazole in 4 or 8 Weeks Healing in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD) of Los Angeles (LA) Grades A to D

The goal of this clinical trial is to find out how well linaprazan glurate can heal erosive esophagitis (EE) caused by gastroesophageal reflux disease (GERD), compared to lansoprazole, a commonly used medication. Researchers will also evaluate whether linaprazan glurate:
* Reduces heartburn symptoms more effectively than lansoprazole
* Is safe and well tolerated, based on physical exams, blood tests, and vital signs (heart rate, blood pressure, temperature, and breathing rate)
* Causes any side effects during treatment
* Has different effects depending on how much of the drug is in the blood
* Works differently depending on participants' genes
Participants must be between 18 to 80 years old and have EE due to GERD confirmed by an endoscopy. Participants cannot join if they have an active Helicobacter pylori (HP) infection or were treated for HP in the past 6 weeks or have taken antibiotics or bismuth-containing drugs in the past 6 weeks.
The study is a randomized, double-blind, active comparator-controlled trial lasting up to 4 months. Randomized means that participants are assigned by chance (like flipping a coin) to one of the treatment groups and double-blind means neither the participants nor the study team will know which treatment is given. Participants will be placed into one of three groups (about 167 people in each group):
* Linaprazan glurate 50 mg twice a day
* Linaprazan glurate 50 mg once a day
* Lansoprazole 30 mg once a day
Everyone will take 2 tablets and 1 capsule by mouth daily for 8 weeks. Some tablets or capsules will be placebos (look like medicine but contain no active drug). Participants will:
* Undergo an endoscopy in the beginning and after 4 weeks of treatment
* If healing is not observed, another endoscopy may be done at 8 weeks
* During the procedure, doctors will use a thin, flexible tube with a camera to look at the esophagus and take small tissue samples (biopsies)
* Have blood and urine tests at clinic visits to check overall health
* Receive electrocardiograms (ECGs) to monitor heart function
* Complete daily questionnaires on an electronic device about symptoms and experiences

开始日期2025-09-01

申办/合作机构

Cinclus Pharma Holding AB

NCT05742984

/ Completed临床1期

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

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 ; Yektaei, Elham ; Rosenholm, Maria ; 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）

2025-07-06

·信狐药迅

CAR-T细胞药物治疗实体瘤要来了？科济药舒瑞基奥仑赛提交上市申请|新受理（6.23-6.29）

本周药品注册受理数据，分门别类呈现，一目了然。(6.23-6.29）新药上市申请药品名称企业注册分类受理号布瑞哌唑口溶膜海南葫芦娃药业集团股份有限公司2.2CXHS2500069布瑞哌唑口溶膜海南葫芦娃药业集团股份有限公司2.2CXHS2500068舒瑞基奥仑赛注射液恺兴生命科技(上海)有限公司1CXSS2500068信迪利单抗注射液信达生物制药(苏州)有限公司2.2CXSS2500069新药临床申请药品名称企业注册分类受理号ALK2401片艾立康(合肥)医药科技有限公司1CXHL2500628ALK2401片艾立康(合肥)医药科技有限公司1CXHL250062764Cu-TR2205注射液通瑞生物制药(成都)有限公司1CXHL2500626ICP-332片广州诺诚健华医药科技有限公司1CXHL2500621QLH12016胶囊齐鲁制药有限公司1CXHL2500625QLH12016胶囊齐鲁制药有限公司1CXHL2500624TP1001 片生元泽通(上海)医药有限公司1CXHL2500623TP1001 片生元泽通(上海)医药有限公司1CXHL2500622AXT-1003胶囊艾斯拓康医药科技(北京)有限公司1CXHL2500618BT01001滴眼液苏州必扬医药科技有限公司1CXHL2500613BT01001滴眼液苏州必扬医药科技有限公司1CXHL2500612BT01001滴眼液苏州必扬医药科技有限公司1CXHL2500611ICP-248片北京诺诚健华医药科技有限公司1CXHL2500610ICP-248片北京诺诚健华医药科技有限公司1CXHL2500609Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2500617Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2500616Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2500615Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2500614HS-10241片江苏豪森药业集团有限公司1CXHL2500608HS-10241片江苏豪森药业集团有限公司1CXHL2500607JMKX003002片浙江杭煜制药有限公司1CXHL2500606JMKX003002片浙江杭煜制药有限公司1CXHL2500605JMKX003002片浙江杭煜制药有限公司1CXHL2500604戊二酸利那拉生酯胶囊上海生诺医药科技有限公司2.4CXHL2500620戊二酸利那拉生酯胶囊上海生诺医药科技有限公司2.4CXHL2500619流感病毒裂解疫苗(高剂量)武汉生物制品研究所有限责任公司3.2CXSL2500509重组乙型肝炎治疗性疫苗远大赛威信生命科学(南京)有限公司1CXSL2500522重组乙型肝炎治疗性疫苗远大赛威信生命科学(南京)有限公司1CXSL2500521注射用MHB048C明慧医药(杭州)有限公司1CXSL2500520注射用QLC5508齐鲁制药有限公司1CXSL2500519注射用TQB2934(皮下注射)正大天晴药业集团南京顺欣制药有限公司1CXSL2500517ZL-1109注射液再鼎医药(上海)有限公司1CXSL2500516IM96嵌合抗原受体T细胞注射液(IM96 CAR-T细胞注射液)山东金赛生物科技有限公司1CXSL2500515IMS001注射液珠海横琴爱姆斯坦生物科技有限公司1CXSL2500514GR2303注射液智翔(上海)医药科技有限公司1CXSL2500512TQH2722注射液上海正大天晴医药科技开发有限公司1CXSL2500511ALMB-0166注射液上海恩乐迈生物科技有限公司1CXSL2500510TQC2731注射液上海正大天晴医药科技开发有限公司1CXSL2500508VUM02注射液武汉光谷中源药业有限公司1CXSL2500507异体人成纤维细胞注射液椎元医学技术(上海)有限公司1CXSL2500513注射用SHR-1826苏州盛迪亚生物医药有限公司1CXSL2500504培集成干扰素α-2注射液北京凯因科技股份有限公司2.2CXSL2500518阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500506贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2500505仿制药申请药品名称企业注册分类受理号普瑞巴林缓释片石药集团欧意药业有限公司3CYHS2502317普瑞巴林缓释片石药集团欧意药业有限公司3CYHS2502316普瑞巴林缓释片石药集团欧意药业有限公司3CYHS2502315坎地沙坦酯氢氯噻嗪片(Ⅱ)江西施美药业股份有限公司3CYHS2502312坎地沙坦酯氢氯噻嗪片(Ⅰ)江西施美药业股份有限公司3CYHS2502311利多卡因丁卡因乳膏浙江孚诺医药股份有限公司3CYHS2502305注射用氢化可的松琥珀酸钠湖南醇健制药科技有限公司3CYHS2502300氨磺必利口服溶液江苏贝佳制药有限公司3CYHS2502294依巴斯汀口服溶液海南斯达制药有限公司3CYHS2502291法莫替丁注射液南京臣功制药股份有限公司3CYHS2502284注射用吲哚菁绿珠海前列药业有限公司3CYHS2502283对乙酰氨基酚布洛芬片华益药业科技(安徽)有限公司3CYHS2502281对乙酰氨基酚布洛芬片健民药业集团股份有限公司3CYHS2502290盐酸丙卡特罗颗粒广州一品红制药有限公司3CYHS2502289叶酸片赤峰固得药业有限公司3CYHS2502288盐酸丙卡特罗颗粒广州一品红制药有限公司3CYHS2502287复方聚乙二醇(3350)电解质口服溶液重庆万霖生物医药科技有限公司3CYHS2502273比拉斯汀口服溶液合肥亿帆生物制药有限公司3CYHS2502257硫糖铝口服混悬液合肥国高药业有限公司3CYHS2502256依巴斯汀口服溶液任曦医药科技河北有限公司3CYHS2502258注射用赖氨匹林南京黄龙生物科技有限公司3CYHS2502249注射用赖氨匹林南京黄龙生物科技有限公司3CYHS2502248沙库巴曲缬沙坦钠片天津力生制药股份有限公司4CYHS2502319氯沙坦钾氢氯噻嗪片裕松源药业有限公司4CYHS2502318瑞维那新吸入溶液山东京卫制药有限公司4CYHS2502314氢溴酸替格列汀片江苏谦仁生物科技有限公司4CYHS2502313甲磺酸溴隐亭片湖南明瑞制药股份有限公司4CYHS2502310乌帕替尼缓释片湖南千金湘江药业股份有限公司4CYHS2502309普拉洛芬滴眼液浙江莎普爱思药业股份有限公司4CYHS2502308盐酸阿罗洛尔片北京华素制药股份有限公司4CYHS2502307瑞维那新吸入溶液立生医药(苏州)有限公司4CYHS2502306复方甘草酸苷片广东方盛健盟药业有限公司4CYHS2502304酒石酸溴莫尼定滴眼液合肥利民制药有限公司4CYHS2502302蛋白琥珀酸铁口服溶液江苏广承药业有限公司4CYHS2502301吡仑帕奈口服混悬液山东新华制药股份有限公司4CYHS2502299氧(气态)陕西亚泰气体有限责任公司4CYHS2502298布洛芬混悬液亚宝药业四川制药有限公司4CYHS2502297苯磺酸左氨氯地平片石家庄市华新药业有限责任公司4CYHS2502296苯磺酸左氨氯地平片石家庄市华新药业有限责任公司4CYHS2502295利格列汀片山西德元堂药业有限公司4CYHS2502293伊布替尼胶囊成都康弘药业集团股份有限公司4CYHS2502292乙酰半胱氨酸注射液四川信拓医药技术有限公司4CYHS2502303佩玛贝特片天方药业有限公司4CYHS2502285沙库巴曲缬沙坦钠片裕松源药业有限公司4CYHS2502282硫酸氢氯吡格雷片四川新斯顿制药股份有限公司4CYHS2502280盐酸西替利嗪滴剂江苏天士力帝益药业有限公司4CYHS2502279双氯芬酸钠双释放肠溶胶囊天津梅花生物医药科技有限公司4CYHS2502277左卡尼汀口服溶液江西施美药业股份有限公司4CYHS2502276乙酰半胱氨酸注射液山东如至生物医药科技有限公司4CYHS2502286富马酸福莫特罗吸入溶液鲁南贝特制药有限公司4CYHS2502278阿昔莫司胶囊安徽美来药业股份有限公司4CYHS2502272富马酸伏诺拉生片山东新华制药股份有限公司4CYHS2502271地屈孕酮片北京斯利安药业有限公司4CYHS2502270铝碳酸镁咀嚼片上海强生制药有限公司4CYHS2502269乙酰半胱氨酸注射液吉林敖东药业集团延吉股份有限公司4CYHS2502274乙酰半胱氨酸注射液安徽长江药业有限公司4CYHS2502275奥卡西平口服混悬液浙江恒研医药科技有限公司4CYHS2502262非布司他片天津力生制药股份有限公司4CYHS2502261非布司他片天津力生制药股份有限公司4CYHS2502260佩玛贝特片北京福元医药股份有限公司4CYHS2502259非布司他片迪沙药业集团有限公司4CYHS2502268复方氨基酸注射液(18AA-IX)辽宁民康制药有限公司4CYHS2502267氧大连隆源气体科技股份有限公司4CYHS2502266氧河南鹤益空气液化有限公司4CYHS2502265氧(液态)河南鹤益空气液化有限公司4CYHS2502264枸橼酸莫沙必利片浙江昂利康制药股份有限公司4CYHS2502263富马酸伏诺拉生片昆明源瑞制药有限公司4CYHS2502255美阿沙坦钾片国药集团容生制药有限公司4CYHS2502254富马酸伏诺拉生片昆明源瑞制药有限公司4CYHS2502253美阿沙坦钾片国药集团容生制药有限公司4CYHS2502252硫酸氨基葡萄糖胶囊苏州俞氏药业有限公司4CYHS2502251阿法骨化醇滴剂江苏明德制药有限公司4CYHS2502250尼洛替尼胶囊仁合熙德隆药业有限公司4CYHS2502247尼洛替尼胶囊仁合熙德隆药业有限公司4CYHS2502246氟哌噻吨美利曲辛片广东健信制药股份有限公司4CYHS2502245苯磺酸左氨氯地平片江苏迪赛诺制药有限公司4CYHS2502244重组人促卵泡激素注射液成都景泽生物制药有限公司3.3CXSS2500071重组人促卵泡激素注射液成都景泽生物制药有限公司3.3CXSS2500070瑞卢戈利片成都倍特药业股份有限公司3CYHL2500122米拉贝隆缓释干混悬剂山东达因海洋生物制药股份有限公司3CYHL2500121盐酸普拉格雷片重庆医药(集团)股份有限公司3CYHL2500120盐酸普拉格雷片重庆医药(集团)股份有限公司3CYHL2500119进口申请药品名称企业注册分类受理号注射用A型肉毒毒素AbbVie Limited3.1JXSS2500098注射用A型肉毒毒素AbbVie Limited3.1JXSS2500097注射用A型肉毒毒素AbbVie Limited3.1JXSS2500096地诺孕素片Annora Pharma Private Limited5.2JYHS2500025利福布汀注射用浓溶液BioVersys AG2.2;2.4JXHL2500153PF-07868489Pfizer Inc.1JXSL2500114VAY736注射液Novartis Pharma AG1JXSL2500113PF-08046054 (注射用冻干粉针)Pfizer Inc.1JXSL2500111ALPN-303注射液Vertex Pharmaceuticals Incorporated1JXSL2500110U3-1402Daiichi Sankyo, Inc.1JXSL2500112中药相关申请药品名称企业注册分类受理号补肾痹通丸新疆维吾尔自治区中医医院1.1CXZL2500042红七片北京华医神农医药科技有限公司1.1CXZL2500041注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

细胞疗法疫苗免疫疗法ASH会议申请上市

2025-06-16

·cincluspharma.com

Cinclus Pharma secures EMA and FDA pediatric study waivers for linaprazan glurate in H. pylori infection

Cinclus Pharma AB (publ), a clinical-stage pharmaceutical company developing next generation treatments for acid-related diseases, today announced that the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have granted exemption from the requirement to conduct pediatric studies with linaprazan glurate for the treatment of Helicobacter pylori (H. pylori) infection. In addition to treating eGERD, linaprazan glurate can in combination with antibiotics potentially be used to treat infections caused by H. pylori, a bacterium found in the stomach. H. pylori infection is a globally prevalent bacterial infection that affects more than half of the world’s population and is associated with gastritis, ulcers and gastric cancer. The WHO lists H. pylori as one of the antibiotic-resistant bacteria that poses the greatest threat to human health. Today, H. pylori infection is treated with acid-inhibiting drugs in combination with two or three antibacterial agents. Antibiotic resistance in these treatments is high and increasing, which is seen as a major problem. Cinclus Pharma’s linaprazan glurate, with its unique acid control properties, has potential to be at least as effective or better than current standard treatments while requiring only a single narrow spectrum antibiotic - thereby reducing the antibiotic use and the risk of resistance. The EMA and FDA waivers remove all requirements for pediatric studies, which would otherwise have been mandatory to obtain market approval in the EU and the US respectively for the treatment of H. pylori infection. "These regulatory waivers represent a meaningful milestone for Cinclus Pharma, streamlining the potential development of linaprazan glurate in H. pylori and enabling us to pursue this significant market opportunity more efficiently. With a differentiated profile and reduced reliance on antibiotics, linaprazan glurate has the potential to redefine the treatment paradigm for H. pylori infection. A potential approval for H. pylori infection would extend the data exclusivity of linaprazan glurate from 5 to 10 years in the US and from 10 to 11 years in Europe.", says Christer Ahlberg, CEO of Cinclus Pharma. Cinclus Pharma has full global commercial rights outside China for linaprazan glurate for the treatment of H. pylori as this indication was not part of the recently announced agreement with Zentiva for the commercialization and manufacture of linaprazan glurate on the European market. 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 Cinclus Pharma secures EMA and FDA pediatric study waivers for linaprazan glurate in H. pylori infection

引进/卖出临床2期临床1期

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

100 项与戊二酸利那拉生酯相关的药物交易

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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

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适应症	最高研发状态	国家/地区	公司	日期
食管炎	临床3期	美国	Cinclus Pharma Holding AB	2025-09-01
食管炎	临床3期	保加利亚	Cinclus Pharma Holding AB	2025-09-01
食管炎	临床3期	捷克	Cinclus Pharma Holding AB	2025-09-01
食管炎	临床3期	德国	Cinclus Pharma Holding AB	2025-09-01
食管炎	临床3期	匈牙利	Cinclus Pharma Holding AB	2025-09-01
食管炎	临床3期	波兰	Cinclus Pharma Holding AB	2025-09-01
食管炎	临床3期	罗马尼亚	Cinclus Pharma Holding AB	2025-09-01
胃食管反流	临床3期	美国	Cinclus Pharma Holding AB	2025-09-01
胃食管反流	临床3期	保加利亚	Cinclus Pharma Holding AB	2025-09-01
胃食管反流	临床3期	捷克	Cinclus Pharma Holding AB	2025-09-01

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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)	壓艱夢繭範範廠選齋衊(範窪膚顧鹹蓋獵夢鬱糧) = 鏇糧顧繭鏇衊醖製簾網糧廠壓範構齋築積構獵 (鑰窪鬱繭遞廠鬱鏇鬱壓, 1650.6) 更多	-	2025-05-07
				Linaprazan Glurate (50 mg Linaprazan Glurate QD)	壓艱夢繭範範廠選齋衊(範窪膚顧鹹蓋獵夢鬱糧) = 廠憲艱積憲觸淵壓鑰鹽糧廠壓範構齋築積構獵 (鑰窪鬱繭遞廠鬱鏇鬱壓, 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	鑰簾簾構鹽糧鬱膚醖窪(鏇壓艱遞觸繭窪衊衊顧) = 衊廠餘選淵廠餘網壓構網繭鹽齋築衊窪衊糧鹽 (製願遞夢廠鏇鑰遞積鹽 ) 更多	积极	2025-04-04
				Lansoprazole	鑰簾簾構鹽糧鬱膚醖窪(鏇壓艱遞觸繭窪衊衊顧) = 築築糧壓觸選製廠糧繭網繭鹽齋築衊窪衊糧鹽 (製願遞夢廠鏇鑰遞積鹽 ) 更多
NCT04531475 (Phase 2 study, Pubmed \| Clin Transl Gastroenterol)	临床2期	糜烂性食管炎	90	X842 50 mg	餘觸廠夢衊觸壓齋願簾(簾夢繭壓構蓋遞襯壓窪) = The incidence of drug-related treatment-emergent adverse events did not differ among groups 鏇製醖構顧齋壓願簾網 (夢醖顧窪繭鏇醖衊憲蓋 ) 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)	鑰蓋襯構蓋餘製壓鏇衊(築範製膚壓顧網範壓壓) = 醖鏇簾顧淵鑰夢蓋鹽築製齋繭選蓋遞觸衊膚鬱 (襯醖願鬱鏇窪襯憲獵夢, 5649) 更多	-	2025-01-03
				Midazolam+Linaprazan glurate hydrochloride (HCl) (Part II)	窪鹹憲觸觸糧餘齋憲選(觸觸築範壓膚網糧壓膚) = 憲鏇齋顧觸鹹齋網窪醖鹽夢夢選衊範壓網獵膚 (餘遞襯構鏇鹽窪繭夢鬱, 13.98) 更多
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)	齋獵餘鑰鏇襯鹹醖觸衊 = 觸醖鑰淵淵選壓衊鹹顧膚膚襯顧蓋網蓋膚構積 (築網艱範鹽鬱糧壓蓋築, 鏇廠鏇構淵餘選觸膚鑰 ~ 選衊獵齋遞構淵鹽壓夢) 更多	-	2023-11-01
				Lansoprazole+X842 Dummy (X842 50 mg BID)	齋獵餘鑰鏇襯鹹醖觸衊 = 夢蓋顧窪獵製夢淵膚齋膚膚襯顧蓋網蓋膚構積 (築網艱範鹽鬱糧壓蓋築, 艱夢襯築廠積襯糧夢壓 ~ 餘齋簾鏇觸淵窪積鑰鏇) 更多
UEGW2023	N/A	-	-	Linaprazan glurate 25 mg BID	夢艱鑰襯製憲鬱選簾鏇(憲蓋觸憲淵鏇鏇艱製艱) = 鏇齋憲壓構範衊鏇醖願鑰鹹夢鑰衊夢製築築窪 (糧築顧憲簾夢網觸鏇廠, 59.7 ~ 84.7)	-	2023-10-15
				Linaprazan glurate 50 mg BID	夢艱鑰襯製憲鬱選簾鏇(憲蓋觸憲淵鏇鏇艱製艱) = 鹹願餘餘構蓋糧襯餘鏇鑰鹹夢鑰衊夢製築築窪 (糧築顧憲簾夢網觸鏇廠, 73.8 ~ 91.1)