更新于：2024-12-10
Keverprazan Hydrochloride
盐酸凯普拉生
更新于：2024-12-10
概要
基本信息
药物类型 小分子化药 |
别名 Caprasan Hydrochloride、Carenoprazan、Kenuolazan hydrochloride + [4] |
作用机制 质子泵抑制剂 |
非在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C22H26ClFN2O4S |
InChIKeyJWWFXPUXOBHMCJ-UHFFFAOYSA-N |
CAS号2209911-80-6 |
关联
29
项与 盐酸凯普拉生 相关的临床试验A clinical study on the combination therapy of Keverprazan and Amoxicillin for the eradication of Helicobacter pylori infection
多中心、随机、盲法、阳性药平行对照的Ⅱ期临床研究评价 H008注射液不同
剂量给药方案用于消化性溃疡引起的上消化道出血经内镜治疗后降低再出血
风险的有效性和安全性
Comparison of Keverprazan-amoxicillin dual therapy versus bismuth quadruple therapy for Helicobacter pylori eradication: a prospective randomized controlled trial
100 项与 盐酸凯普拉生 相关的临床结果
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100 项与 盐酸凯普拉生 相关的转化医学
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100 项与 盐酸凯普拉生 相关的专利（医药）
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8
项与 盐酸凯普拉生 相关的文献（医药）2024-11-01Current 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.
2024-11-01INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
The efficacy of keverprazan-based quadruple therapy for Helicobacter pylori eradication: A phase III, randomised, double-blind, multicentre trial
Article
作者: Qiu, Rongyuan ; Li, Xing ; Liu, Chengxia ; Su, Dongxing ; Tan, Niandi ; Li, Fangfang ; Liu, Youli ; Xia, Min ; Jiao, Zhiyong ; Zhang, Zhe ; Su, Mei ; Chen, Huixin ; Zhang, Xiaomei ; Liao, Aijun ; Xiao, Weiming ; Xiao, Yinglian ; Wu, Hao ; Chen, Minhu ; Lan, Cheng
INTRODUCTION:
Keverprazan is a novel potassium-competitive acid blocker. The advantages of keverprazan as a potent acid suppressor in Helicobacter pylori eradication have not yet been demonstrated. The aim of this study was to evaluate the efficacy of keverprazan as a component of bismuth quadruple therapy in H. pylori treatment.
METHODS:
Adult patients with H. pylori infection were enrolled and randomised to take keverprazan (KEV group)- or esomeprazole (ESO group)-quadruple therapy. The regimens contained keverprazan 20 mg or esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg and bismuth potassium citrate 240 mg and were administered twice daily for 14 days. The primary endpoint was the H. pylori eradication rate at 4 weeks after treatment.
RESULTS:
The full analysis set showed that the H. pylori eradication rates were 87.8% (252/287) and 82.52% (236/286) for the KEV and ESO groups, respectively (difference: 5.29%; 95% confidence interval [CI]: -0.55-11.18). Keverprazan was superior to esomeprazole in terms of eradication rate in the per protocol set (P=0.0382). The eradication rates for patients resistant or non-resistant to clarithromycin were both numerically higher in the KEV group than the ESO group (83.45% vs. 76.98% for clarithromycin-resistance; 92.31% vs. 88.16% for clarithromycin-non-resistance). The incidence of adverse events was similar in the KEV and ESO groups (76.31% vs. 77.62%), with most adverse events (>90%) being mild in severity. No TEAEs led to death in either group.
CONCLUSIONS:
Keverprazan 20 mg twice daily, used as a component of bismuth quadruple therapy, provided effective H. pylori eradication and was non-inferior to an esomeprazole-based regimen.
2024-01-01Therapeutic Advances in Gastroenterology
Potassium-competitive acid blockers and proton-pump inhibitors for healing of erosive esophagitis: a systematic review and network meta-analysis
Review
作者: Gao, Zhifeng ; Liu, Yin ; Hou, XiaoHua
Background::
Proton-pump inhibitors (PPIs) and potassium-competitive acid blockers (P-CABs) are recommended for erosive esophagitis (EE), with good safety and tolerance. However, it is unclear which is the best treatment option for EE.
Objectives::
This study aimed to evaluate the comparative efficacy of P-CABs and PPIs for healing EE patients, seeking an appropriate treatment choice in the 4- or 8-week treatment and standard or double dose.
Design::
A systematic review and network meta-analysis.
Data sources and methods::
Relevant databases were searched to collect randomized controlled trials of PPIs and P-CABs in the treatment of EE up to 31 May 2023. Studies on standard or double-dose PPIs or P-CABs which were published in English and assessed 4- or 8-week healing effects in EE were included. A network meta-analysis was performed to evaluate the efficacy of the treatments under the frequentist framework. Sensitivity and subgroup analyses of patients with different baseline EE were also conducted.
Results::
In all, 34 studies involving 25,054 patients and 9 PPIs, 6 P-CABs, or placebo treatment interventions were included. The pooled 4-week healing rate was significantly statistically lower than the pooled 8-week healing rate for most treatments. Besides, the higher healing rate of double-dose treatment than standard-dose treatment was not observed in the initial treatment of most drugs. The main analysis only included studies conducted for both patients with and without severe EE at baseline, and the proportion of severe EE included in the study was >10%, Keverprazan 20 mg qd ranked best with a surface under the cumulative ranking curve (SUCRA) value of 84.7, followed by Ilaprazole 10 mg qd with a SUCRA value of 82.0, for the healing rate at 8 weeks. Sensitivity analysis showed that the results were robust. Subgroup analysis showed that most P-CABs had higher healing rates than PPIs, particularly for patients with severe EE. And the healing rate of Keverprazan 20 mg qd at 8 weeks ranked best in the subgroup without or with severe EE at baseline.
Conclusion::
This study showed that an 8-week treatment seemed more effective than the 4-week treatment for healing EE patients. The healing effect of Keverprazan (20 mg qd) ranked best in 8-week treatment, for both severe and non-severe EE patients.
Trial registration::
The study protocol was registered with INPLASY (registration number INPLASY2023120053).
100 项与 盐酸凯普拉生 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, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 幽门螺杆菌感染 | 中国 | 2024-10-29 | |
| 十二指肠溃疡 | 中国 | 2023-02-14 | |
| 反流性食管炎 | 中国 | 2023-02-14 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 消化性溃疡出血 | 临床2期 | 中国 | 2024-10-16 | |
| 消化性溃疡出血 | 临床2期 | 中国 | 2024-10-16 | |
| 糜烂性食管炎 | 临床1期 | 美国 | 2021-06-24 | |
| 早期胃癌 | 临床1期 | 中国 | 2018-09-03 | |
| 早期胃癌 | 临床1期 | 中国 | 2018-09-03 | |
| 幽门螺杆菌相关性胃炎 | 临床1期 | 中国 | 2018-09-03 | |
| 幽门螺杆菌相关性胃炎 | 临床1期 | 中国 | 2018-09-03 | |
| 胃MALT淋巴瘤 | 临床1期 | 中国 | 2018-09-03 | |
| 胃MALT淋巴瘤 | 临床1期 | 中国 | 2018-09-03 | |
| 免疫性血小板减少症 | 临床1期 | 中国 | 2018-09-03 |
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临床结果
临床结果
适应症
分期
评价
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Pubmed 人工标引  | 临床3期 | 360 | 憲選鏇積積繭鹽壓顧蓋(顧繭願衊鬱廠鏇顧觸鬱) = 蓋鬱獵壓遞鹽夢顧構遞 廠願鬱糧膚糧糧夢醖獵 (鹽廠獵鹽鏇鑰窪餘選夢 ) 更多 | 非劣 | 2023-07-01 | ||
憲選鏇積積繭鹽壓顧蓋(顧繭願衊鬱廠鏇顧觸鬱) = 鏇鏇繭餘廠鹽選選艱膚 廠願鬱糧膚糧糧夢醖獵 (鹽廠獵鹽鏇鑰窪餘選夢 ) 更多 | |||||||
Pubmed 人工标引 | 临床3期 | 238 | 醖齋鏇膚構製鏇築鏇鑰(廠糧築艱窪餘鏇艱鏇觸) = 蓋膚廠鹽鏇淵網淵鑰觸 積繭範窪築遞襯鑰鹹願 (廠鑰築範構選選蓋鑰膚 ) 更多 | 非劣 | 2022-05-03 | ||
醖齋鏇膚構製鏇築鏇鑰(廠糧築艱窪餘鏇艱鏇觸) = 遞鬱窪衊鹹廠糧醖願顧 積繭範窪築遞襯鑰鹹願 (廠鑰築範構選選蓋鑰膚 ) 更多 | |||||||
临床2期 | 十二指肠溃疡 一线 | - | 憲憲醖觸衊齋積淵鹹鏇(鹹蓋餘遞膚繭築襯網廠) = 淵鏇壓餘遞壓顧願淵蓋 壓廠淵鬱鏇鬱鹹蓋築壓 (廠獵餘鑰餘廠膚積鹽繭 ) 更多 | 积极 | 2021-10-02 | ||
憲憲醖觸衊齋積淵鹹鏇(鹹蓋餘遞膚繭築襯網廠) = 構壓顧蓋衊襯顧艱遞網 壓廠淵鬱鏇鬱鹹蓋築壓 (廠獵餘鑰餘廠膚積鹽繭 ) 更多 |
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