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更新于：2026-07-01
Linaprazan glurate
戊二酸利那拉生酯
更新于：2026-07-01
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2024-12-01), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C26H32N4O5 |
InChIKeyGPHPBXRKAJSSIC-UHFFFAOYSA-N |
CAS号1228559-81-6 |
关联
16
项与 戊二酸利那拉生酯 相关的临床试验CTR20260168
多中心、随机、双盲双模拟、阳性药平行对照的Ⅲ期临床研究评价X842胶囊含铋剂四联疗法根除幽门螺杆菌的有效性和安全性
主要目的：评价在含铋剂四联疗法中联合 X842 胶囊对比联合艾司奥美拉唑镁肠溶片（耐信®）对所有 Hp阳性（+）受试者进行 Hp 根除治疗的疗效，以验证 X842 胶囊辅助根除 Hp 的疗效非劣效于艾司奥美拉唑镁肠溶片；
次要目的：评价在含铋剂四联疗法中联合 X842 胶囊对比联合艾司奥美拉唑镁肠溶片（耐信®）对克拉霉素耐药的 Hp+受试者进行 Hp 根除治疗的疗效； 评价在含铋剂四联疗法中联合 X842 胶囊对比联合艾司奥美拉唑镁肠溶片（耐信®）对阿莫西林耐药的 Hp+受试者进行 Hp 根除治疗的疗效；评价含铋剂四联疗法中联合 X842 胶囊对所有 Hp+受试者进行 Hp 根除治疗的安全性。
开始日期2026-03-11 |
申办/合作机构 上海生诺医药科技有限公司 [+1] |
NCT07313774
A Randomized, Phase 3, Double-blind, Double-dummy, Active Comparator-controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Linaprazan Glurate Compared to Lansoprazole in Maintenance of Healing in Participants With Healed 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 investigate how well linaprazan glurate can maintain healed erosive esophagitis (EE) caused by GERD in participants who have participated in a prior healing trial, compared to lansoprazole (an approved treatment for GERD). Researchers will also examine:
* the effect of linaprazan glurate on heartburn symptoms compared to lansoprazole.
* whether linaprazan glurate treatment is safe and tolerable, based on symptoms and procedures such as blood and urine tests, endoscopy, and electrocardiograms (measure the heart's electrical activity). Endoscopy means that the doctor will insert a thin, flexible tube with a camera down the throat to look at each participant's esophagus area and collect small tissue samples (called biopsies).
* the side effects that may happen during treatment with linaprazan glurate.
Participants must be between 18 to 80 years old and have participated in a prior healing trial with healed EE (due to GERD) confirmed by an endoscopy either from the prior healing trial or from the initial period of this trial. Participants cannot participate if they are not healed, had to stop trial treatment because of a side effect in a prior healing trial, or if they have a condition that could make it unsafe.
The study is a randomized, double-blind, active comparator-controlled clinical trial lasting for almost 14 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:
* Linaprazan glurate - High dose
* Linaparazan glurate - Low dose, and
* Lansoprazole - marketed approved dose Everyone will take a total of 2 tablets and 1 capsule orally every day for up to 52 weeks. The tablets and capsule will be separated into a morning dose and an evening dose. Some tablets or capsules will be placebos (look like medicine but contain no active drug).
Participants will complete several questionnaires on an electronic device during treatment. An endoscopy will be performed after 24 weeks of treatment to determine if healing has been maintained. If healing has been maintained, the participant will continue taking trial treatment and another endoscopy will be performed at 52 weeks. If healing has not been maintained at 24 weeks or if the participant has reached 52 weeks, the participant will stop taking trial treatment and return for a follow up visit.
* the effect of linaprazan glurate on heartburn symptoms compared to lansoprazole.
* whether linaprazan glurate treatment is safe and tolerable, based on symptoms and procedures such as blood and urine tests, endoscopy, and electrocardiograms (measure the heart's electrical activity). Endoscopy means that the doctor will insert a thin, flexible tube with a camera down the throat to look at each participant's esophagus area and collect small tissue samples (called biopsies).
* the side effects that may happen during treatment with linaprazan glurate.
Participants must be between 18 to 80 years old and have participated in a prior healing trial with healed EE (due to GERD) confirmed by an endoscopy either from the prior healing trial or from the initial period of this trial. Participants cannot participate if they are not healed, had to stop trial treatment because of a side effect in a prior healing trial, or if they have a condition that could make it unsafe.
The study is a randomized, double-blind, active comparator-controlled clinical trial lasting for almost 14 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:
* Linaprazan glurate - High dose
* Linaparazan glurate - Low dose, and
* Lansoprazole - marketed approved dose Everyone will take a total of 2 tablets and 1 capsule orally every day for up to 52 weeks. The tablets and capsule will be separated into a morning dose and an evening dose. Some tablets or capsules will be placebos (look like medicine but contain no active drug).
Participants will complete several questionnaires on an electronic device during treatment. An endoscopy will be performed after 24 weeks of treatment to determine if healing has been maintained. If healing has been maintained, the participant will continue taking trial treatment and another endoscopy will be performed at 52 weeks. If healing has not been maintained at 24 weeks or if the participant has reached 52 weeks, the participant will stop taking trial treatment and return for a follow up visit.
开始日期2026-03-01 |
申办/合作机构 |
CTR20254718
多中心、随机、双盲双模拟、阳性药平行对照的Ⅲ期临床研究评价X842胶囊用于十二指肠溃疡患者的有效性和安全性
主要目的：评价X842胶囊每日1次50mg连续给药4到6周对十二指肠溃疡的内镜下溃疡愈合的有效性，以验证X842胶囊在6周内的内镜下溃疡愈合受试者比例非劣效于兰索拉唑肠溶胶囊；
次要目的：与兰索拉唑肠溶胶囊相比，评价X842胶囊改善十二指肠溃疡受试者的临床症状（上腹疼痛、胃烧灼感、反酸、恶心、呕吐、嗳气和腹胀）的有效性；与兰索拉唑肠溶胶囊相比，评价X842胶囊治疗十二指肠溃疡的安全性；观察X842胶囊用于十二指肠溃疡患者后血清胃泌素的治疗前后变化情况。
开始日期2025-12-17 |
申办/合作机构 上海生诺医药科技有限公司 [+1] |
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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8
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: Michael Vaezi ; Kajsa Larsson ; Elham Yektaei ; Peter Unge ; Maria Rosenholm ; Andras Rosztóczy ; Prateek Sharma ; David Armstrong ; Ivan Popadiyn ; Kjell Andersson
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: Jin Xiu ; Ying Yang ; Donghui Liu ; Ming Lu ; Chen Yang ; Xingxing Diao ; Xinyue Zhang ; Yali Yuan ; Yuandong Zheng ; Pingsheng Hu
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 AUC0-24h 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.
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项与 戊二酸利那拉生酯 相关的新闻（医药）2026-06-30
胃食管反流病（GERD）、消化性溃疡及幽门螺杆菌感染是临床最为常见的酸相关性疾病，抑酸治疗是上述疾病管理的重要策略。质子泵抑制剂（PPI）一直是酸相关性疾病药物治疗的基石。然而，PPI存在诸多固有缺陷——需要在酸性环境中活化、起效缓慢、对夜间酸突破控制不佳、受CYP2C19基因多态性影响大、需餐前服用等。
钾离子竞争性酸阻滞剂（Potassium-Competitive Acid Blockers，P-CAB），与传统PPI不同，P-CAB通过可逆性竞争性阻断胃壁细胞H⁺/K⁺-ATP酶的K⁺结合位点抑制胃酸分泌，无需酸激活、起效迅速、首剂即达全效、抑酸作用更强且更持久。
目前，我国已获批上市并纳入国家医保目录的P-CAB药物共有四种：富马酸伏诺拉生片、替戈拉生片、盐酸凯普拉生片和戊二酸利那拉生酯胶囊，其中后三者为2025国谈药品。随着P-CAB类药物在临床的广泛应用，如何规范、合理、个体化地使用这四种药物，已成为临床医师面临的重要问题。本指总结四种P-CAB类药物的药理特征、临床应用及安全性管理，仅供临床参考。1、胃酸分泌的生理基础与P-CAB的作用靶点1.1 质子泵的两种功能状态
胃壁细胞胞浆内含有丰富的管泡结构，当受到进食等刺激时，这些管泡移向细胞顶端并融合形成胃酸分泌小管。胃酸分泌小管膜上的H⁺/K⁺-ATP酶（即质子泵）通过水解ATP获得能量，借助H⁺/K⁺交换机制，逆浓度梯度将H⁺泵入胃腔。
根据质子泵的分布位置和功能状态，可将其分为两种类型：
活化态质子泵：指位于胃酸分泌小管膜上的H⁺/K⁺-ATP酶，已整合入分泌小管膜，处于主动泌酸状态。
静息态质子泵：指位于胃壁细胞胞浆内管泡结构中的H⁺/K⁺-ATP酶，尚未移位至分泌小管膜上，不直接参与胃酸分泌。
两种状态之间存在动态转化：在进食等刺激下，胞浆内的静息态质子泵可随管泡移行至分泌小管膜上，转化为活化态并开始分泌胃酸。1.2 PPI与P-CAB作用机制的差异
PPI的作用机制：PPI为前体药物，需在分泌小管腔的强酸性环境中活化，生成具有活性的次磺酰胺衍生物，然后与活化态质子泵的半胱氨酸残基形成不可逆的二硫键共价结合，使质子泵永久失活。PPI的活化产物无法穿透细胞膜回流入胃壁细胞内，因此仅能抑制已位于膜上的活化态质子泵，对胞浆内的静息态质子泵无作用。
P-CAB的作用机制：P-CAB无需酸激活，以离子键和氢键等非共价键方式与质子泵结合，竞争性占据K⁺结合位点，阻断H⁺与K⁺的交换。由于P-CAB具有脂溶性，可自由穿透细胞膜，因此既能与膜上的活化态质子泵结合，也能与胞浆内的静息态质子泵结合。这种双重抑制作用使P-CAB在抑酸广度和深度上优于PPI。1.3 P-CAB的药代动力学优势
与传统PPI相比，P-CAB在药代动力学方面具有显著优势：
起效迅速：P-CAB口服后迅速吸收，无需酸激活，服药第1天即可达到最大抑酸效果。相比之下，PPI需连续给药3~5天才能达到稳态抑酸水平。
半衰期长：P-CAB的消除半衰期明显长于PPI（伏诺拉生约6~8小时，替戈拉生约3.8~4.6小时，凯普拉生约6~7小时，利那拉生酯约8.68小时），而PPI的半衰期通常仅为45分钟至3小时。
不受进食影响：P-CAB通常无需餐前服用，给药时间灵活。
不受CYP2C19基因多态性影响：P-CAB主要经CYP3A4代谢，不受CYP2C19基因多态性的显著影响，个体差异小，疗效可预期性强。2、四种P-CAB药物的适应证与用法用量2.1 伏诺拉生（Vonoprazan，商品名：沃克®）
伏诺拉生由武田制药研发，是全球首个获批的P-CAB类药物，2014年12月在日本率先上市。2019年12月在我国获批，2023年11月获美国FDA批准用于GERD治疗。
获批适应证：
反流性食管炎；
与适当的抗生素联用根除幽门螺杆菌。
用法用量：
反流性食管炎：成人每日1次，每次20mg，口服。疗程4~8周，大部分患者4周可获益，疗效不佳者可延长至8周。
根除幽门螺杆菌：伏诺拉生20mg每日2次，联合阿莫西林、克拉霉素及铋剂组成四联方案，疗程14天。
维持治疗：反流性食管炎愈合后维持治疗推荐剂量为每次10mg每日1次；疗效不佳者可增至20mg每日1次。
关键临床数据：
多项随机对照试验显示，伏诺拉生在重度食管炎（LA分级C/D级）的黏膜愈合方面优于标准剂量PPI。
基于伏诺拉生的根除Hp方案，根除率可达90%以上，在克拉霉素耐药菌株中也显示出良好疗效。
注意事项：
正在接受阿扎那韦或利匹韦林治疗的患者禁用；
主要通过CYP3A4代谢，部分通过CYP2B6、CYP2C19和CYP2D6代谢；
服用本品可能掩盖胃恶性肿瘤的症状，开始使用前应排除恶性肿瘤的可能；
不建议与吸收依赖于胃内pH的药物（如某些抗真菌药、酪氨酸激酶抑制剂等）同服。2.2 替戈拉生（Tegoprazan，商品名：泰欣赞®）
替戈拉生由韩国HK inno.N公司研发，2018年在韩国率先获批。2022年4月在我国获批上市。
获批适应证：
反流性食管炎；
十二指肠溃疡；
与适当的抗生素联用根除幽门螺杆菌。
用法用量：
反流性食管炎：成人50mg，每日1次，连续治疗8周；
十二指肠溃疡：成人50mg，每日1次，连续治疗6周；
根除幽门螺杆菌：替戈拉生50mg + 阿莫西林1000mg + 克拉霉素500mg + 枸橼酸铋钾240mg，每日2次，联合服用14天。
关键临床数据：
反流性食管炎患者8周黏膜愈合率达98.9%；
十二指肠溃疡患者6周溃疡愈合率达96.9%；
四联方案Hp根除率达93.5%；
单次给药后约1.7小时达峰浓度，抑酸作用持续24小时。
注意事项：
尽管替戈拉生不影响肝脏CYP450酶系统，但与经CYP2C19代谢的药物（如氯吡格雷）合用时，理论上可能影响后者的抗血小板活性（pH改变影响氯吡格雷吸收，影响极小）；
不建议与吸收依赖于胃内pH的药物同服；
肝肾功能不全者应谨慎使用。2.3 凯普拉生（Keverprazan，商品名：倍稳®）
凯普拉生由复星医药与柯菲平医药联合开发，是我国自主研发的1类创新药，于2023年2月获批。该药对伏诺拉生的分子结构进行了优化，通过增强水溶性和提升胃内分布浓度，在药代动力学层面实现更快速、更高效的抑酸效率。
获批适应证：
反流性食管炎；
十二指肠溃疡；
与适当的抗生素联用根除幽门螺杆菌。
用法用量：
反流性食管炎：成人20mg，每日1次；
十二指肠溃疡：成人20mg，每日1次；
根除幽门螺杆菌：需与抗生素、铋剂组成四联方案。
重要提醒：
需整片吞服，不可咀嚼或压碎；
建议在早餐前服用：高脂饮食对凯普拉生的药物暴露量（AUC）及峰浓度（Cmax）有一定影响；
半衰期约6~7小时。2.4 利那拉生酯（Linaprazan Glurate）
利那拉生酯由上海生诺医药研发，是我国自主研发的又一P-CAB类药物，2024年获批。利那拉生酯为前体药物，口服后在羧酸酯酶作用下快速水解为活性成分利那拉生。
获批适应证：
反流性食管炎。
用法用量：
反流性食管炎：成人50mg，每日1次，空腹服用（药品说明书明确要求）。
药代动力学特点：
吸收迅速，约0.5~1小时达峰；
半衰期约8.68小时，在四种P-CAB中半衰期最长。
研发进展：
十二指肠溃疡及幽门螺杆菌感染根除适应证正在开展临床三期研究。四种P-CAB药物的PK特点比较
3、国内外指南与专家共识推荐3.1 中国指南与共识
《中国胃食管反流病诊疗规范（2023）》：由中华医学会消化病学分会发起，从GERD的临床表现、诊断方法、诊断流程和治疗规范等方面进行了系统总结，P-CAB被列为一线治疗药物。
《老年人胃食管反流病中国专家共识（2023）》：由中华医学会老年医学分会发布，指出PPI及P-CAB是老年GERD的首选治疗药物。老年GERD具有症状不典型、食管损伤相对较重、并发症较多等特点，P-CAB的快速强效抑酸特点对老年患者具有特殊价值。
《咽喉反流性疾病诊断与治疗专家共识（2022年，修订版）》：由中华耳鼻咽喉头颈外科杂志编辑委员会咽喉组及中华医学会耳鼻咽喉头颈外科学分会咽喉学组发布，药物治疗方案中纳入P-CAB。3.2 国际指南与共识
AGA临床实践更新（2024）：美国胃肠病协会（AGA）发布《将P-CAB纳入临床实践专家建议》，针对P-CAB在GERD、Hp感染和消化性溃疡疾病中的应用提出了9条最佳实践建议。主要建议包括：对于尚未证明临床优效的酸相关疾病，一般不应将P-CAB作为初始治疗；对于轻度糜烂性食管炎（LA分级A/B级），一般不应将P-CAB作为一线治疗；对于重度糜烂性食管炎（LA分级C/D级），可将P-CAB作为愈合和维持愈合的治疗选择；在Hp根除方案中，应在大多数患者中使用P-CAB替代PPI。
American Foregut Society白皮书（2025）：美国前肠学会（AFS）23项声明涵盖P-CAB药代动力学（3项）、糜烂性食管炎（5项）、非糜烂性反流病（3项）、安全性（4项）及临床实践（8项）。该白皮书指出，P-CAB抑制胃酸分泌的速度、持续时间和强度均优于PPI。
Current Opinion in Gastroenterology综述（2025）：系统回顾了P-CAB在GERD、消化性溃疡和Hp感染中的应用，指出P-CAB在随机对照试验中不劣于甚至优于PPI，尤其在重度食管炎愈合和Hp根除方面表现突出。P-CAB在超过10年的使用中安全性令人安心，但强效酸抑制可能导致高胃泌素血症和胃肠道感染风险增加。3.3 临床综合评价
一项基于《中国医疗机构药品评价与遴选快速指南（第二版）》的临床综合评价显示，三种已上市P-CAB的5个维度评分从高到低依次为：富马酸伏诺拉生片（81.8分）、替戈拉生片（75.7分）、盐酸凯普拉生片（75.6分）。在药学特性、有效性、经济性及其他属性4个维度中，伏诺拉生得分均最高。三种P-CAB均为强推荐。3.4 国内外指南差异
临床用药评价公众号：东西方指南在P-CAB的定位上存在一定差异。AGA建议在未证明临床优效的情况下不将P-CAB作为一线治疗，主要考量因素是美国的药物成本和长期安全性数据不足。而中国指南则更为积极地推荐P-CAB作为首选治疗药物之一。这种差异反映了不同国家和地区在药物可及性、医疗经济学和临床实践习惯上的区别。在中国，P-CAB已纳入国家医保目录，药物可及性高、患者经济负担小，将其作为一线治疗具有充分的现实基础。4、夜间酸突破的管理4.1 定义与临床意义
夜间胃酸突破（NAB）：指患者在服用抑酸药物期间，当日22:00至次日8:00胃内pH＜4.0的时间＞1小时。NAB在PPI治疗患者中发生率较高，是PPI治疗失败的重要原因之一。4.2 PPI发生NAB的机制
PPI发生NAB的根本原因在于其药理特性的局限性：
消除半衰期短（约45分钟至3小时），夜间血药浓度不足以维持有效抑酸；
仅能抑制活化态质子泵，对夜间因无进食刺激而处于静息状态的质子泵无效；
需连续给药3~5天才能达到稳态，起效缓慢。4.3 P-CAB控制NAB的优势
P-CAB在控制NAB方面具有显著优势：
半衰期长（6~9小时），单次给药即可覆盖全天24小时；
同时抑制活化态和静息态质子泵，不受进食状态影响；
首剂全效，服药第1天即可实现全天候强效抑酸；
研究显示，替戈拉生与伏诺拉生可有效控制NAB，并改善反流相关咳嗽等食管外症状。
临床建议：对于PPI治疗下出现NAB的患者，建议更换为P-CAB类药物。5、特殊人群用药与安全性管理5.1 常见不良反应
P-CAB的不良反应谱与PPI类似，总体耐受性良好。常见不良反应包括鼻咽炎、头痛、恶心、腹泻、上呼吸道感染、胃肠炎及肝功能异常等。治疗后可能发生的严重不良事件包括药物诱导的肝损伤、急性间质性肾炎等，但发生率较低。5.2 长期用药风险
长期（＞6个月）使用P-CAB可能导致以下风险：
高胃泌素血症：P-CAB导致胃泌素水平升高的幅度大于PPI，可能诱导胃壁细胞和G细胞增生。虽然目前尚无明确证据表明这与胃癌风险增加直接相关，但长期用药者应定期监测胃泌素水平。
胃底腺息肉：长期强效抑酸可导致胃底腺息肉发生率增加。
低镁血症：长期使用抑酸药物可能影响镁的吸收，尤其是合并使用利尿剂或其他影响电解质药物的患者。
维生素B₁₂缺乏：长期强效抑酸可能影响食物中维生素B₁₂的释放和吸收。
胃肠道感染风险：强效抑酸削弱了胃酸这一重要的防御屏障，可能增加艰难梭菌感染等肠道感染的风险。5.3 特殊人群用药建议
肝功能损伤患者：伏诺拉生在轻度、中度和重度肝功能障碍患者中的AUC分别为肝功能正常者的1.2~2.6倍。中重度肝功能不全者应慎用并加强监测。
肾功能损伤患者：伏诺拉生在轻度、中度和重度肾功能障碍患者中的AUC分别为肾功能正常者的1.3~2.4倍。中重度肾功能不全者应慎用并监测。
老年患者：老年人长期应用P-CAB应持谨慎态度。老年GERD患者症状不典型、食管损伤较重，P-CAB的强效抑酸有其价值，但长期用药的风险-获益比需个体化评估。
妊娠及哺乳期妇女：目前缺乏足够的人体安全性数据，不建议在妊娠及哺乳期使用。5.4 药物相互作用
P-CAB主要经CYP3A4代谢。
伏诺拉生：不应与阿扎那韦、利匹韦林等依赖胃内pH的抗逆转录病毒药物联用；与强效CYP3A4诱导剂（如利福平）合用时，伏诺拉生AUC预计降低80%；与中度CYP3A4诱导剂合用时，AUC预计降低50%；会导致胃内pH升高，不建议与吸收依赖于胃内pH的药物（如某些抗真菌药、酪氨酸激酶抑制剂等）同服。
替戈拉生：尽管替戈拉生不影响肝脏CYP450酶系统，但与经CYP2C19代谢的药物（如氯吡格雷）合用时需谨慎。
临床建议：合并用药时需仔细评估药物相互作用风险，必要时调整剂量或更换药物。6、临床应用建议6.1 GERD/反流性食管炎
初始治疗：四种P-CAB均可作为初始治疗选择。根据中国GERD专家共识，P-CAB与PPI同为一线选择。对于重度糜烂性食管炎（LA分级C/D级），P-CAB较标准剂量PPI在黏膜愈合方面具有优势，可优先考虑。对于轻度糜烂性食管炎（LA分级A/B级），P-CAB与PPI疗效相当，可根据患者具体情况、医保政策和药物可及性选择。
维持治疗：P-CAB可作为GERD维持治疗的选择之一，尤其是对于PPI维持治疗下仍有症状或出现NAB的患者。伏诺拉生维持治疗推荐剂量为10mg每日1次，疗效不佳者可增至20mg每日1次。
难治性GERD：对于PPI（包括每日2次）治疗失败的GERD患者，建议更换为P-CAB。印度专家共识推荐伏诺拉生20mg每日1次、疗程4~8周作为难治性GERD的初始治疗策略。6.2 十二指肠溃疡
替戈拉生和凯普拉生已获批十二指肠溃疡适应证。推荐剂量：替戈拉生50mg每日1次，疗程6周；凯普拉生20mg每日1次，疗程6周。6.3 幽门螺杆菌根除
伏诺拉生、替戈拉生、凯普拉生均已获批Hp根除适应证。AGA建议在Hp根除方案中，应在大多数患者中使用P-CAB替代PPI。国内指南推荐含铋剂的四联方案，疗程14天。P-CAB为基础的根除方案在克拉霉素耐药菌株中仍保持较高根除率。6.4 服药管理
伏诺拉生、替戈拉生：空腹或餐后均可，不受进食影响；凯普拉生：建议早餐前服用（高脂饮食影响吸收）；利那拉生酯：必须空腹服用（药品说明书明确要求）。6.5 监测与随访
长期用药（＞6个月）者应定期监测血镁、维生素B₁₂水平；关注肝功能变化，尤其在合并用药时；长期用药者应考虑监测胃泌素水平；出现新发消化道症状时，应排除胃恶性肿瘤的可能。总 结
P-CAB作为新一代抑酸药物，凭借其独特的药理机制——无需酸激活、同时抑制活化态和静息态质子泵、可逆性竞争性结合——在起效速度、抑酸强度和持久性方面均实现了对传统PPI的进步。伏诺拉生、替戈拉生、凯普拉生和利那拉生酯四种药物均已在中国获批并纳入国家医保目录，为临床提供了丰富的治疗选择。
在临床应用中，应根据患者的具体疾病类型、疾病严重程度、合并用药、肝肾功能状况及经济条件等因素，进行个体化的药物选择和用药方案制定。对于重度食管炎、难治性GERD、PPI治疗下出现NAB的患者以及需要进行Hp根除的患者，P-CAB具有明确的临床优势。
随着P-CAB在全球范围内更广泛的应用，更多真实世界数据将进一步明确这类药物在不同酸相关性疾病中的最佳定位。同时，P-CAB长期用药的安全性（尤其是高胃泌素血症的远期影响）仍需持续关注和深入研究。
参考文献：
1. Spechler S, Kolb JM, Dunbar K, et al. American Foregut Society White Paper Report on the Use of Potassium-Competitive Acid Blockers in the Treatment of Gastroesophageal Reflux Disease[J]. Foregut, 2025, 5(3): 195-215.
2. AGA Clinical Practice Update on Integrating Potassium-Competitive Acid Blockers Into Clinical Practice: Expert Review[J]. Gastroenterology, 2024, 167(6): 1228-1238.
3. 2025 Focused Update of the Seoul Consensus on Gastroesophageal Reflux Disease: Evidence-based Recommendations on Acid Suppressive Therapy[J]. Journal of Neurogastroenterology and Motility, 2026, 32(1): 7-18.
4. Association of Physicians of India Consensus Recommendations for Vonoprazan in Management of Acid Peptic Disorders. 2025.
5. Davis TA, Gyawali CP. Potassium-competitive acid blockers[J]. Current Opinion in Gastroenterology, 2025, 41(6): 389-398.
6. 中华医学会消化病学分会胃肠动力学组, 胃肠功能性疾病协作组, 食管疾病协作组. 中国胃食管反流病诊疗规范[J]. 中华消化杂志, 2023, 43(9): 588-598.
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2026-06-03
Cinclus Pharma Holding AB (publ), a clinical pharmaceutical company developing next‑generation treatments for gastric acid‑related diseases, today announced the successful completion of screening of patients in the pivotal Phase III HEEALING1 trial evaluating linaprazan glurate in erosive gastroesophageal reflux disease (GERD). The company is on track to deliver topline results in Q4 2026.
Linaprazan glurate is a next-generation potassium-competitive acid blocker (PCAB) that demonstrated strong efficacy in the Phase II LEED study (Linaprazan glurate Erosive Esophagitis Dose Ranging). In patients with moderate to severe erosive GERD, linaprazan glurate achieved four-week healing rates of up to 93% compared to 38% for comparator lansoprazole, a standard proton pump inhibitor (PPI). These results are particularly relevant given that standard PPI therapy fails to heal a significant proportion of the most severe patients, representing a substantial unmet medical need in an estimated 19 million patients worldwide. “Data from our previous preclinical and clinical studies have demonstrated significant potential for linaprazan glurate. The HEEALING1 study is designed to confirm those results in a larger, well-powered patient population, and we look forward to presenting the study results,” said Kajsa Larsson, Chief Medical Officer of Cinclus Pharma. Following the completion of screening, after reaching the target number of screened patients, Cinclus Pharma is on track to deliver topline data in Q4 2026, marking an important step toward a potential regulatory submission and subsequent commercialization. The company’s second Phase III study, HEEALING2, which will also evaluate maintenance therapy, is the final study before submission for approval and is planned to commence in both the US and Europe following the HEEALING1 readout. “HEEALING1 has enrolled on schedule and we remain on track to report topline results before year-end. The unmet medical need in severe erosive GERD is well-documented, and our Phase II data give us strong confidence in linaprazan glurate's ability to deliver meaningfully better outcomes for this patient population. We view the upcoming topline readout from the study as a key clinical milestone for Cinclus Pharma,” said Christer Ahlberg, CEO of Cinclus Pharma. About the HEEALING1 Study The pivotal HEEALING1 (Healing of Erosive Esophagitis with unique Acid control using Linaprazan Glurate) study is designed to confirm the efficacy of linaprazan glurate in patients with erosive GERD. The randomized, double-blind trial compares linaprazan glurate to the current standard of care, a proton pump inhibitor (PPI), with a primary focus on superior healing rates, faster healing time, and improved symptom control. The trial enrolls approximately 500 patients in eight European countries. Participants undergo an up to eight-week treatment period. The primary endpoint is superiority to the proton pump inhibitor lansoprazole in healing of patients with moderate to severe erosive GERD (LA grade C/D) after 4 weeks. Secondary endpoints include healing and symptom relief for up to 8 weeks. Top-line results from the HEEALING1 study are expected in Q4 2026. The second healing study, HEEALING2, which will also evaluate maintenance therapy, and represents the final study prior to regulatory submission, is planned to commence in both the US and Europe following the topline results of HEEALING1. About Linaprazan Glurate Linaprazan glurate is a next-generation of potassium competitive acid blockers (PCAB) with a unique acid control inhibiting profile that enables enhanced healing and symptom relief in patients with severe forms of acid-related diseases. It is a prodrug of linaprazan, designed to optimize pharmacokinetics by providing sustained acid suppression with lower peak plasma concentrations. Phase II data for linaprazan glurate have demonstrated robust healing efficacy, particularly in patients with severe erosive GERD. In the randomized, double-blind LEED study, linaprazan glurate achieved healing rates of up to 93% at four weeks in patients with LA grade C/D disease, compared to just 38% for lansoprazole. In patients with only partial response after 8 weeks of PPI treatment, linaprazan glurate showed 100% healing after 4 weeks of treatment in the best dosing group. About Erosive GERD Erosive GERD is a severe form of GERD characterized by visible erosions or ulcerations in the esophageal lining, typically confirmed via endoscopy. Severity is graded from A to D using the Los Angeles Classification system, with grades C and D representing the most extensive mucosal injury. Patients with severe erosive GERD often experience more persistent symptoms, slower healing, and a reduced response to conventional PPI therapy. This population represents a significant unmet medical need, with an estimated 19 million patients affected globally, including over 10 million in Europe and the US. In patients with LA grade C/D disease, healing rates with PPIs at four weeks can be as low as 30–40%, underscoring the need for more effective treatment options.
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. The first Phase III study commenced 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 Achieves Key Phase III Milestone: Last Patient Screened in HEEALING1 Study
临床2期临床结果临床3期
2026-06-01
·赛柏蓝
作者 | 晓琳
编辑 | 郑瑶
近年来，在集采常态化及创新药商业化加速的背景下，A股化学制剂企业销售团队数量正经历分化。
01
60家化药企业
销售人员减少
同花顺-问财数据显示，106家化学制剂企业中，与2021年相比，2025年有60家减少了销售人员。不过，总体来看销售人员共减少2128人，整体降幅比中药企业温和。
这60家企业中，15家减员超50%；12家减员在30%-40%之间；33家减员不到20%。
减员幅度最高的是三圣股份，其次是奥赛康，不过这两家药企销售人员基数小，2021年销售团队规模仅一二百人。人数上减少较多的有誉衡药业、罗欣药业和丰原药业。
2021年誉衡药业销售团队达3341人，到2025年销售人员降至1055人。其在2022年、2023年每年减员千人左右。伴随销售团队精简，其五年间销售费用也同步降低72.69%至18.17亿元。
对于销售费用的下降，誉衡药业表示，主要因集采政策带来的市场费用缩减。目前，其核心产品多种维生素（12）、氯化钾缓释片和鹿瓜多肽注射液，已分别中选5个、4个及1个地方联盟集采。
2025年，罗欣药业销售人员缩减至815人，主要与剥离长期亏损的中成药业务、关停低效原料药产能、退出竞争力薄弱的仿制药品种有关。其年内已陆续转让乐康制药100%股权及罗欣安若维他20%股权。
罗欣药业表示，虽营收规模短期有所收缩，但盈利质量与资产效率显著改善——2025年经营性现金净流入2.53亿元，主要得益于医院回款速度加快以及严控库存规模，当年扣非净利润同比减亏62.50%。
丰原药业也是一家老牌药企，1997年成立，2000年在深交所上市，是安徽省首家医药上市公司。2022年，丰原药业销售团队就已减少至581人，随后又小幅增加。
其营收主要来源于化学合成药及制剂产品（化学仿制药为主）、药品批发，其中前者2025年营收12.06亿元，占总营收31.26%，但毛利率仅为34.16%。这几年，其连续降低销售费用来提升盈利能力。
02
创新药商业化加速
销售人数增加
与2021年相比，2025年有45家药企扩大了销售团队规模。具体分布为：增幅超100%的有10家；50%-100%的有15家；20%-50%的有10家，不足20%的有10家。
销售人员增长明显的企业多为创新药企业，产品正处于商业化加速落地阶段。
亚虹医药在2023年迅速组建肿瘤产品营销团队，扩容至134人。当年第四季度开始销售治疗晚期肾细胞癌的培唑帕尼片（迪派特）和治疗早期乳腺癌的马来酸奈拉替尼片（欧优比）。
2025年，亚虹医药推进商业化2.0升级，销售队伍增加至251人。欧优比在早期乳腺癌市场持续渗透，同时当年8月新增上市甲磺酸艾立布林注射液（欧纳琳），进军晚期乳腺癌市场。2025年，亚虹医药营收同比增长37.49%至2.77亿元。
上海谊众因核心产品注射用紫杉醇聚合物胶束2022年上市，其销售团队当年明显扩容，利润也由2021年亏损1773万元转为2022年扣非归母净利润1.03亿元。
此后，该产品在2024年纳入国家医保目录，2025年进入医保执行期，显著缓解了产品自费阶段准入难的问题，上海谊众营收2025年同比增加82.14%至31.61亿元，销售人员数量也增加至147人。
艾力斯销售人员在2024年破千，2025年增至1516人，销售队伍扩张同样得益于医保的持续赋能。
2024年，其核心产品甲磺酸伏美替尼片二线治疗适应症、一线治疗适应症均被续约纳入国家医保报销范围，公司扩大销售团队并细化分工，销售队伍覆盖31个省市约4800家医院。到了2025年12月，其枸橼酸戈来雷塞片、普拉替尼胶囊也被纳入国家医保目录，进一步打开商业化空间。
从数量上看，百济神州、海思科、华东医药销售人员增加得较多。
前两者同样因创新药商业化放量而增加销售人员，华东医药则更为多元，包括加强对现有产品基层医疗市场、院外零售市场拓展；发力医美及工业微生物等新业务板块；加大在肿瘤、内分泌及自免等领域的创新药布局，销售人员由2021年的6608人增加至2025年的12479人。
2025年，华东医药的迈瑞东（马来酸美凡厄替尼片）等6款创新产品成功获批上市。同时，派舒宁（塞纳帕利胶囊）、信立安（戊二酸利那拉生酯）均进入2025年国家医保目录；CAR-T产品赛恺泽（泽沃基奥仑赛注射液）纳入国家首版商保目录。
基层市场方面，华东医药（贵州）药业组建了自营推广团队，推进核心产品苗药复方中成药外用制剂伤科灵准入，并持续拓展零售药店覆盖。截至2025年，该产品覆盖基层医疗机构近9500家，零售药店覆盖突破12万家。
五年来，化学制剂企业销售人员数量的变化之下是行业从重营销向创新驱动转变。
附：106家A股上市化学制剂企业2021年与2025年销售人员、费用变化表
END
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
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 反流性食管炎 | 中国 | 2024-12-01 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 幽门螺杆菌感染 | 临床3期 | 中国 | 2026-03-11 | |
| 幽门螺杆菌感染 | 临床3期 | 中国 | 2026-03-11 | |
| 十二指肠溃疡 | 临床3期 | 中国 | 2025-12-17 | |
| 食管炎 | 临床3期 | 美国 | 2025-09-11 | |
| 食管炎 | 临床3期 | 保加利亚 | 2025-09-11 | |
| 食管炎 | 临床3期 | 捷克 | 2025-09-11 | |
| 食管炎 | 临床3期 | 德国 | 2025-09-11 | |
| 食管炎 | 临床3期 | 匈牙利 | 2025-09-11 | |
| 食管炎 | 临床3期 | 波兰 | 2025-09-11 | |
| 食管炎 | 临床3期 | 罗马尼亚 | 2025-09-11 |
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临床结果
临床结果
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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 |
|---|
临床1期 | 75 | (25 mg Linaprazan Glurate QD) | 餘積觸網糧蓋衊願糧廠(網淵網窪淵製齋積糧觸) = 襯糧選窪積夢蓋遞鏇壓 餘選願淵範鏇艱糧觸艱 (鹹鑰鹽餘願網餘積鹹選, 1650.6) 更多 | - | 2025-05-07 | ||
(50 mg Linaprazan Glurate QD) | 餘積觸網糧蓋衊願糧廠(網淵網窪淵製齋積糧觸) = 製醖艱膚觸壓餘選選獵 餘選願淵範鏇艱糧觸艱 (鹹鑰鹽餘願網餘積鹹選, 2281.0) 更多 | ||||||
临床2期 | 248 | 獵襯鹹窪鑰窪壓網鏇積(網鹹壓積簾簾餘積餘襯) = 淵衊願襯獵窪襯鑰糧糧 願餘網繭襯築廠廠鬱壓 (鹹餘蓋網製獵繭製齋壓 ) 更多 | 积极 | 2025-04-04 | |||
獵襯鹹窪鑰窪壓網鏇積(網鹹壓積簾簾餘積餘襯) = 鏇繭構獵鬱願糧鹹鹹襯 願餘網繭襯築廠廠鬱壓 (鹹餘蓋網製獵繭製齋壓 ) 更多 | |||||||
临床1期 | - | 67 | (Reference Formulation (Treatment A)) | 範夢鹹積網鹽獵鹽遞選(窪鬱夢壓構顧糧艱築廠) = 鬱壓觸壓選蓋蓋築衊築 壓範簾繭壓繭餘蓋餘築 (憲鏇蓋遞壓範壓選遞鏇, 1.51) 更多 | - | 2025-04-03 | |
(Test Formulation (Treatment B)) | 範夢鹹積網鹽獵鹽遞選(窪鬱夢壓構顧糧艱築廠) = 簾網鏇夢築鏇淵積範淵 壓範簾繭壓繭餘蓋餘築 (憲鏇蓋遞壓範壓選遞鏇, 1.32) 更多 | ||||||
临床2期 | 90 | 齋鹹願積積遞蓋網範簾(鹽齋鑰顧繭鬱鏇夢膚繭) = The incidence of drug-related treatment-emergent adverse events did not differ among groups 鹽廠鹹繭鏇願襯網醖憲 (夢憲膚糧網積簾鬱獵壓 ) 更多 | 积极 | 2025-04-01 | |||
临床1期 | 35 | (Part I) | 鹽鏇鹽齋夢鏇範網淵淵(鏇窪淵願鹽築憲膚糧構) = 蓋鹹齋壓鬱積襯糧壓糧 膚繭願範襯膚獵鑰齋餘 (簾蓋糧網糧獵蓋夢觸網, 5649) 更多 | - | 2025-01-03 | ||
Midazolam+Linaprazan glurate hydrochloride (HCl) (Part II) | 構壓製鹽獵膚鏇積積蓋(鬱壓觸築夢簾鹹鑰襯鏇) = 簾願構壓艱壓醖糧夢鹽 廠構積膚鑰網醖淵壓範 (艱糧繭憲糧網範襯鹹鹽, 13.98) 更多 | ||||||
临床2期 | 248 | (X842 25 mg BID) | 鬱窪艱餘繭齋積憲顧壓 = 鹽積膚選鏇築網繭遞繭 鹽窪糧糧製淵餘膚顧膚 (憲鹽範獵顧淵鬱範膚鏇, 醖願網淵廠製壓廠觸鬱 ~ 範獵鹽艱鹹憲選觸簾齋) 更多 | - | 2023-11-01 | ||
(X842 50 mg BID) | 鬱窪艱餘繭齋積憲顧壓 = 鬱遞製鏇簾選遞窪醖齋 鹽窪糧糧製淵餘膚顧膚 (憲鹽範獵顧淵鬱範膚鏇, 餘製觸齋製艱觸鏇顧壓 ~ 憲窪鏇壓糧遞壓繭廠鬱) 更多 | ||||||
N/A | - | - | Linaprazan glurate 25 mg BID | 齋夢鹹鑰艱膚廠艱鹽遞(顧鏇夢網膚選構窪簾艱) = 築襯網糧憲蓋遞淵積願 網構憲鹽鹹願膚選鬱廠 (餘窪艱齋願壓積齋蓋壓, 59.7 ~ 84.7) | - | 2023-10-15 | |
Linaprazan glurate 50 mg BID | 齋夢鹹鑰艱膚廠艱鹽遞(顧鏇夢網膚選構窪簾艱) = 構廠鹽顧膚窪齋淵襯鑰 網構憲鹽鹹願膚選鬱廠 (餘窪艱齋願壓積齋蓋壓, 73.8 ~ 91.1) |
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