甲磺酸萘莫司他(Nafamostat Mesilate) - 药物靶点：Serine protease_在研适应症：弥散性血管内凝血，出血，胰腺炎_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Nafamostat、Nafamostat Mesylate、p-Guanidinobenzoic acid ester with 6-hydroxy-2-naphthamidine

+ [9]

靶点

Serine protease

作用方式

抑制剂

作用机制

丝氨酸蛋白酶家族抑制剂

治疗领域

消化系统疾病血液及淋巴系统疾病其他疾病+ [2]

在研适应症

弥散性血管内凝血出血胰腺炎+ [3]

非在研适应症

慢性胰腺炎创伤性胰腺炎

原研机构

Nichi-Iko Pharmaceutical Co., Ltd.

在研机构

Nichi-Iko Pharmaceutical Co., Ltd.

Ensysce Biosciences, Inc.

Talphera, Inc.

+ [1]

非在研机构

兰州京陇医药科技有限公司

山东百诺医药股份有限公司

权益机构

University of Tokyo

Nichi-Iko Pharmaceutical Co., Ltd.

Torii Pharmaceutical Co., Ltd.

+ [1]

最高研发阶段批准上市

首次获批日期

日本 (1989-03-31),

弥散性血管内凝血出血胰腺炎

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、孤儿药 (欧盟)

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结构/序列

分子式C21H25N5O8S2

InChIKeySRXKIZXIRHMPFW-UHFFFAOYSA-N

CAS号82956-11-4

关联

61

项与甲磺酸萘莫司他相关的临床试验

NCT07518303

/ Not yet recruiting临床4期IIT

Nafamostat Mesylate Versus Regional Citrate Anticoagulation for Continuous Renal Replacement Therapy in Sepsis-Associated Acute Kidney Injury

This multicenter, randomized, open-label, active-controlled, parallel-group trial will evaluate the efficacy and safety of nafamostat mesylate anticoagulation compared with regional citrate anticoagulation in adult patients with sepsis-associated acute kidney injury requiring continuous renal replacement therapy. Eligible participants will be randomized in a 1:1 ratio to receive either nafamostat mesylate or regional citrate anticoagulation during CRRT. The primary outcome is MAKE30, a composite of all-cause mortality, new or ongoing renal replacement therapy, or persistent renal dysfunction within 30 days after randomization. Secondary outcomes include filter lifespan, CRRT-free days, 30-day all-cause mortality, renal replacement therapy status, persistent renal dysfunction, ICU and hospital mortality, length of stay, CRRT duration, major bleeding, new bloodstream infection during ICU stay, SOFA score, number of filters used, and protocol-defined safety outcomes.

开始日期2026-06-10

申办/合作机构

东南大学

[+1]

ChiCTR2600126113

/ Not yet recruitingN/AIIT

Comparison of anticoagulant and anti-inflammatory effects of nintedostat mesylate and heparin in artificial liver support system: a multicenter randomized controlled study

开始日期2026-06-01

申办/合作机构-

NCT07469072

/ Recruiting临床2期IIT

Comparison of Anticoagulant Effects of Different Doses of Nafamostat in Continuous Renal Replacement Therapy (CRRT) in the Intensive Care Unit (ICU): A Single-Center, Randomized, Open-Label, Parallel-Controlled Clinical Trial

This is a single-center, randomized, open-label, parallel-controlled clinical trial designed to investigate the anticoagulation efficacy and safety of different initial doses of Nafamostat Mesilate (NM) in ICU patients undergoing Continuous Renal Replacement Therapy (CRRT). Researchers will screen patients admitted to the Department of Critical Care Medicine at Zhujiang Hospital, Southern Medical University, to identify eligible participants based on inclusion and exclusion criteria. After obtaining informed consent, participants will be randomized into two groups.
On the basis of standardized CRRT treatment, the Low-Dose Group (Group A) will receive a continuous infusion of Nafamostat Mesilate at an initial dose of 20 mg/h, while the High-Dose Group (Group B) will receive an initial dose of 50 mg/h. The drug will be continuously infused pre-filter into the CRRT circuit. Dosage adjustments will be made for both groups to maintain target anticoagulation levels while ensuring that pre-filter safety limits are not exceeded. The primary outcome measure is filter lifespan, along with other secondary outcomes.

开始日期2026-04-07

申办/合作机构-

100 项与甲磺酸萘莫司他相关的临床结果

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100 项与甲磺酸萘莫司他相关的转化医学

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100 项与甲磺酸萘莫司他相关的专利（医药）

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1,049

项与甲磺酸萘莫司他相关的文献（医药）

2026-12-31·RENAL FAILURE

Implementation quality as a modifiable determinant of filter lifespan in regional citrate anticoagulation: a real-world clustering-adjusted study

Article

作者: He, Dan ; Liang, Zhili ; Yan, Wenjuan ; Wang, Hongjuan ; Liu, Yanan ; Ou, Qing ; Li, Yucheng ; Zeng, Zhenhua ; Wei, Hongyun ; Hu, Hongbin

Continuous renal replacement therapy (CRRT) is widely used in critically ill patients, but filter clotting remains a common complication. Regional citrate anticoagulation (RCA) is recommended; however, its real-world effectiveness may depend on implementation quality. This single-center retrospective cohort study analyzed 420 CRRT sessions from 1 September 2025 to 30 November 2025. Mixed-effects Cox models with patient-level random intercepts and competing-risk analysis were used. The primary outcome was filter clotting. In adjusted analyses, RCA was associated with a significantly reduced hazard of filter clotting compared with heparin (adjusted hazard ratio (aHR) for heparin vs. RCA: 1.78, 95% confidence interval (CI): 1.14-2.77, p = 0.011). Nafamostat showed no statistically significant difference from RCA (aHR: 1.31, 95% CI: 0.78-2.19, p = 0.31); however, the wide CI reflects limited sample size, and equivalence cannot be inferred. Within the RCA group, absence of timely post-filter ionized calcium (iCa²⁺) monitoring within 2 h was independently associated with increased clotting risk (adjusted odds ratio: 2.18, 95% CI: 1.24-3.84, p = 0.007), with a dose-response relationship (each one-hour delay increased clotting odds by 15%, p = 0.02). Major bleeding was infrequent (2.1% overall); metabolic complications (citrate accumulation) occurred in 2.9% of RCA sessions. In this cluster-adjusted real-world cohort, RCA was associated with improved filter survival compared with heparin. Implementation fidelity, particularly timely post-filter iCa²⁺ monitoring, appears to influence RCA effectiveness.

2026-12-31·RENAL FAILURE

Risk factors for hypotension and technical complications during single-session double-filtration plasmapheresis: a 15-year retrospective study of 1,022 procedures

Article

作者: Jing, Meng ; Ma, Jun ; Gao, Chenni ; Chen, Xiaonong ; Zhu, Yujia ; Chen, Zijin ; Yu, Haijin ; Yang, Zhenhua ; Xie, Jingyuan

Double-filtration plasmapheresis (DFPP) is increasingly used for immune-mediated and hematologic diseases, yet real-world safety data remain limited. In this 15-year retrospective study, we analyzed 1,022 DFPP sessions performed in 385 patients. The primary outcomes were hypotension and technical complications. Patient demographics, indications, laboratory parameters, treatment prescriptions, anticoagulation regimens, and procedure-related adverse events were collected. Mixed-effects logistic regression models were applied to identify factors associated with hypotension and technical complications. Hyperviscosity syndrome was the most common indication, accounting for 55.3% of all sessions. The mean treatment volume was 3.06 ± 0.41 L, corresponding to 0.95 ± 0.16 times the estimated plasma volume. Hypotension occurred in 15.3% of sessions and technical complications in 7.6%, both demonstrating significant declining trends over time (p < 0.05 for trend). Immune thrombotic thrombocytopenic purpura was independently associated with hypotension (OR 11.96, 95% CI 1.94-73.68). Older age modestly increased risk (OR 1.03 per year, 95% CI 1.00-1.06), while treatment year was inversely associated with hypotension (OR 0.77 per year, 95% CI 0.66-0.89). Technical complications were independently associated with use of the PLASAUTO Σ system (OR 8.78, 95% CI 2.76-27.97), use of non-heparin/non-nafamostat anticoagulants (OR 9.42, 95% CI 2.71-32.72), and hyperviscosity syndrome (OR 8.09, 95% CI 1.80-36.29). Among 309 sessions with paired measurements, median immunoglobulin reduction was 29.8% for IgG overall. DFPP demonstrated an acceptable safety profile, with declining complication rates over time. The risk of complications was influenced by underlying disease, patients' status, and anticoagulation strategy.

2026-05-14·JOURNAL OF GENERAL VIROLOGY

Establishment of a human coronavirus HKU1 infection evaluation system using apical-out airway organoids

Article

作者: Sugimoto, Satoko ; Go, Hayato ; Kawase, Miyuki ; Kakizaki, Masatoshi ; Hashimoto, Koichi ; Okabe, Hisao ; Shirato, Kazuya ; Norito, Sakurako

Human coronavirus HKU1 (HCoV-HKU1) is difficult to study because it does not propagate in standard cell lines. Consequently, research has relied on the air–liquid interface model, which is limited by long culture periods and the absence of cytopathic effects (CPEs). To address these challenges, we established an infection evaluation system using apical-out airway organoids (AOAOs). Derived from human bronchial epithelial cells, AOAOs supported efficient HCoV-HKU1 replication, and immunofluorescence revealed a preferential infection of ciliated cells. Notably, HCoV-HKU1 induced a distinct CPE characterized by organoid dissociation, enabling the quantification of viral titres via the TCID 50 assay. Applying this model to antiviral testing, the serine protease inhibitor nafamostat effectively inhibited viral infection and CPE, consistent with the known entry mechanism. Thus, AOAOs provide a rapid, scalable and reproducible platform for HCoV-HKU1 research, overcoming limitations of traditional systems. This approach enables reliable viral replication analysis, titre determination and drug evaluation and may accelerate research on difficult-to-culture respiratory viruses.

195

项与甲磺酸萘莫司他相关的新闻（医药）

2026-08-05

·PRNewswire

Talphera to Report Second Quarter 2026 Financial Results on Wednesday, August 12, 2026

SAN MATEO, Calif., Aug. 5, 2026 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it will host a conference call and webcast on Wednesday, August 12, 2026 at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss financial results for the second quarter ended June 30, 2026 and recent business progress. Conference Call and Webcast Information Date: Wednesday, August 12, 2026 at 4:30 PM ET/1:30 PM PT Participant Dial-in (North America): 1-800-836-8184 Participant Dial-in (International): 1-646-357-8785 Conference ID: 50873 Webcast Access: Click here The event can also be accessed in the Upcoming Events page in the Investors section of the Talphera website at . A replay of the webcast will be available on the Talphera website for 90 days after the event. About Talphera, Inc. Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit. Nafamostat has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA). This release is intended for investors only. For additional information about Talphera, please visit . SOURCE Talphera, Inc. 21% more press release views with Request a Demo

财报突破性疗法

2026-08-05

·摩熵医药

282个品种过评，30款首家！超10亿大品种，贵州柏强制药占据70.8%的市场……

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。 7月仿制药月报月报内容亮点 7月一致性评价仿制药申请情况 7月共有14个品种（按受理号计16项）一致性评价申请获CDE承办；申请品种主要为消化系统与代谢药物，申请剂型主要为注射剂；普伐他汀钠片与盐酸异丙肾上腺素注射液为受理号最多的品种，均有2个。 7月新注册分类仿制药申报临床/上市情况 7月共有302项（共计181个品种）新注册分类仿制药申请获CDE承办；新注册分类临床申请8项，新注册分类上市申请294项；主要为消化系统与代谢药物，申请剂型主要为片剂。 7月过评/新注册分类仿制药获批上市信息 7月共有282个（共计492个受理号）品种通过/视同通过一致性评价；一致性评价品种数量24个，视同通过一致性评价品种数量263个。每月相关仿制药申报、仿制药临床申报、仿制药通过/视同通过一致性评价等，摩熵咨询团队基于NMPA、CDE渠道数据，真实可溯源，将每月推出「仿制药月报」，以帮助业内人士通盘把握每月行业范围内的仿制药申报及获批情况。 01 7月一致性评价仿制药申报情况根据摩熵医药数据库统计，2026年7月共有14个品种（按受理号计16项）一致性评价申请获CDE承办，申请品种主要为消化系统与代谢药物，申请剂型主要为注射剂。截图来源：摩熵咨询月报普伐他汀钠片与盐酸异丙肾上腺素注射液为受理号最多的品种，均有2个；长春海悦药业股份有限公司为申请品种数最多的企业，有2个品种。截图来源：摩熵咨询月报 02 7月新注册分类仿制药申报临床/上市信息根据摩熵医药数据库统计，2026年7月期间共有302项（共计181个品种）新注册分类仿制药申请获CDE承办，其中新注册分类临床申请8项，新注册分类上市申请294项。截图来源：摩熵咨询月报本月申请品种主要为消化系统与代谢药物，申请剂型主要为片剂。注射用甲磺酸萘莫司他为申请企业数最多的品种，有12家；辰欣药业股份有限公司与南京海纳制药有限公司是申请品种数最多的企业，各有5个品种。截图来源：摩熵咨询月报 03 7月过评/新注册分类仿制药获批上市信息根据摩熵医药数据库统计，2026年7月期间共有282个（共计492个受理号）品种通过/视同通过一致性评价，其中通过一致性评价品种数量24个，视同通过一致性评价品种数量263个。截图来源：摩熵咨询月报本期过评品种主要为系统用抗感染药物。过评企业数最多的品种为布瑞哌唑片和维生素B6注射液，有8家企业过评。首家过评品种有30个，达七家过评品种有180个。 2026年7月一致性评价过评品种信息一览表（部分）截图来源：摩熵咨询月报 04 7月首家通过/视同通过一致性评价品种根据摩熵医药数据库统计，2026年7月期间共有30个（共计39个受理号）品种首次过评/视同过评一致性评价，过评受理号最多的领域为消化系统与代谢药物与神经系统药物药物，均有7个。过评受理号最多的企业为礼来，有4个。截图来源：摩熵咨询月报 2026年7月首家通过/视同通过一致性评价品种信息一览表截图来源：摩熵咨询月报 05 7月达七家通过/视同通过一致性评价品种根据摩熵医药数据库统计，2026年7月期间共有180个（共计350个受理号）品种一致性评价达七家过评。7月16日，海南元盈医药科技有限公司的维生素B12注射液视同通过一致性评价，过评总企业数达到了9家。截图来源：摩熵咨询月报维生素B12注射液是血液和造血系统药物，主要用于因内因子缺乏所致的巨幼细胞性贫血，也可用于亚急性联合变性神经系统病变，如神经炎的辅助治疗。维生素B12注射液2025年医院端销售额达10.19亿元，贵州柏强制药有限公司以61357.79万元的销售额占据70.8%的市场。截图来源：全球药物研发数据库（查数据.找摩熵） 7月16日，鲁南贝特制药有限公司的阿莫西林克拉维酸钾干混悬剂视同通过一致性评价，过评总企业数达到了11家。阿莫西林克拉维酸钾干混悬剂是青霉素类复方药物，主要用于治疗：1.上呼吸道感染(包括耳、鼻、喉科)：如复发性扁桃体炎、鼻窦炎、中耳炎；2.下呼吸道感染：如急、慢性支气管炎(尤适用于严重感染)、大叶性肺炎、支气管肺炎；3.泌尿系统感染：如膀胱炎(特别是感染反复发作或复杂感染，不包括前列腺炎)；4.皮肤和软组织感染：如蜂窝织炎、动物咬伤合并伤口感染；5.口腔感染：如严重的齿龈脓肿合并颌面部蜂窝织炎。阿莫西林克拉维酸钾干混悬剂2025年医院端销售额达2.77亿元，珠海联邦制药股份有限公司中山分公司以6180.95万元占据22.24%的市场。 2026年7月仿制药完整报告领取识别下方二维码获取完整《2026年7月仿制药月报》PDF版报告本报告在每月初定期发布，敬请期待 END 本文为原创文章，转载请留言获取授权点击阅读原文，申请摩熵医药企业版免费试用！

2026-08-02

·药筛

华海首个创新药瑞西奇拜单抗，九典中药1类新药贴膏获批 | 审评周报（7.27-8.02）

统计每周药品上市申请受理及获批情况（7.27-8.02）上周，NMPA新批件大放送。海思科的1类新药，琥珀酸思普可泮片通过优先审批获批上市，国产第二款口服补体 B 因子（FB）抑制剂，全球第三款。武田的进口奥普雷顿片，获批上市，全球原创靶点新药中国首发上市。用于治疗16岁及以上青少年和成人的1型发作性睡病（NT1）。仿制药高难度制剂，逐步突破。噻托溴铵奥达特罗吸入喷雾剂，苏州艾特美和南昌谷森两家仿制同时获批。石药的棕榈酸帕利哌酮注射液，齐鲁的注射用两性霉素B脂质体，都是第5家仿制获批。江苏知原的盐酸特比萘芬涂膜剂，国内首仿获批。卷王品种，布瑞哌唑片、富马酸伏诺拉生片不断还有新增批文。药品申报方面，成都闻泰医药的首款国产小分子GLP-1制剂VCT220片上市获受理，抢占先机。金赛药业的1类新药金妥昔单抗注射液提交上市申请，国内首款申报上市的抗VEGFR2单克隆抗体。深圳信立泰降压三联复方沙库巴曲阿利沙坦氨氯地平片，提交上市申请。注射用甲磺酸萘莫司他、注射用盐酸兰地洛尔又有企业按免临床提交上市申请。 1、仿制药上市申请获批注：灰色字体部分受理号结论为不批准。 2、新药上市申请获批注：灰色字体部分受理号结论为不批准。 3、一致性评补充申请获批注：灰色字体部分受理号结论为不批准。 4、仿制药上市申请受理 5、新药上市申请受理 6、一致性评价补充申报受理数据来源：摩熵医药用摩熵药筛小程序，快速查看每周申报汇总！

上市批准一致性评价优先审批

100 项与甲磺酸萘莫司他相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	甲磺酸萘莫司他	B02AB	DB12598

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
弥散性血管内凝血	日本	Nichi-Iko Pharmaceutical Co., Ltd.	1989-03-31
出血	日本	Nichi-Iko Pharmaceutical Co., Ltd.	1989-03-31
胰腺炎	日本	Nichi-Iko Pharmaceutical Co., Ltd.	1989-03-31

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
慢性胰腺炎	临床1期	中国	兰州京陇医药科技有限公司	2016-09-14
创伤性胰腺炎	临床1期	中国	兰州京陇医药科技有限公司	2016-09-14
肠道病毒感染	临床1期	美国	Ensysce Biosciences, Inc.	-
新型冠状病毒感染	临床前	美国	Talphera, Inc.	2024-12-01
急性呼吸窘迫综合征	临床前	美国	Talphera, Inc.	2024-12-01

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临床结果

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


Pubmed \| J Biol Chem 人工标引	临床2期	胰腺癌	47	nafamostat mesilate+Gemcitabine+Tegafur+Gimeracil+Oteracil	積範構壓艱壓獵鏇獵選(獵夢鑰鏇鑰蓋鬱築餘遞) = 襯繭網鑰醖繭淵蓋築糧積網願廠餘鹹鹹鏇醖廠 (網範夢遞廠鬱鏇襯願簾, 8.4 ~ 12.0) 更多	积极	2022-05-11
NCT04623021 (Pubmed)	临床2期	新型冠状病毒感染	104	Nafamostat plus standard-of-care (SOC)	夢鑰衊鏇願鬱獵鏇襯窪(構齋構鏇鑰壓鹹襯齋襯) = 齋蓋襯鏇構醖餘齋觸鹽遞鏇遞願構鑰選網壓選 (蓋淵簾衊衊夢襯夢壓襯 )	-	2021-11-01
				Standard-of-care (SOC) alone	夢鑰衊鏇願鬱獵鏇襯窪(構齋構鏇鑰壓鹹襯齋襯) = 願選壓鏇遞鏇顧積獵窪遞鏇遞願構鑰選網壓選 (蓋淵簾衊衊夢襯夢壓襯 )
ASN2021	N/A	-	-	Nafamostat Mesylate	構簾醖築構憲鏇鹹壓繭(積餘壓齋蓋構壓憲築醖) = 窪膚餘鹹鬱壓壓網襯憲願膚範積窪觸築選製壓 (選廠製鬱衊艱衊遞鏇壓, [22 ~ 68])	积极	2021-10-27
				Regional Citrate Anticoagulation	構簾醖築構憲鏇鹹壓繭(積餘壓齋蓋構壓憲築醖) = 廠憲齋製繭窪網遞廠網願膚範積窪觸築選製壓 (選廠製鬱衊艱衊遞鏇壓, [16 ~ 67])
Pubmed \| Pancreas	临床2/3期	ERCP术后胰腺炎	2,956	Nafamostat	鏇鹹觸艱築顧獵築鹽醖(範醖夢積齋鹹襯遞糧顧) = 製遞淵顧構齋鹹選製顧夢簾製觸築蓋鹹簾鏇廠 (遞齋網壓壓廠窪鹹憲遞, 0.34 ~ 0.63)	积极	2015-05-01
				Nonnafamostat	-
ASCO2010	临床2期	胰腺癌	30	Gemcitabine + Nafamostat Mesilate	糧鏇選憲製糧遞簾簾齋(鑰築蓋築膚顧積構鑰膚) = 鏇鹽糧網餘構醖窪鏇廠鏇製壓鬱襯鹹艱窪範艱 (積顧顧夢艱夢衊廠顧築 )	-	2010-05-20
NCT01001403 (CTgov)	临床4期	失盐型肾上腺皮质综合症 \| Prieto X连锁智力低下综合征	62	Nafamostat (Nafamostat)	膚獵膚網淵膚鹽鹹積餘 = 襯築衊蓋獵齋觸繭鬱醖構顧齋餘夢構艱糧鹽繭 (齋夢壓蓋遞淵簾淵窪餘, 簾憲鬱淵簾鏇壓夢膚網 ~ 鑰遞夢憲顧壓衊襯艱夢) 更多	-	2010-05-03
				Normal saline (Control)	膚獵膚網淵膚鹽鹹積餘 = 積壓鑰糧願鬱繭願構襯構顧齋餘夢構艱糧鹽繭 (齋夢壓蓋遞淵簾淵窪餘, 壓糧遞選遞構窪醖顧選 ~ 觸鬱蓋糧遞願獵壓願衊) 更多
ASCO2009	临床1/2期	不能切除性胰腺癌	20	GEM 1,000 mg/m2 + NAM 2.4-4.8 mg/kg	繭壓鏇蓋襯鹹鹽鑰齋醖(構積選淵鬱築夢襯醖窪) = 鑰選鑰窪構鹹鹹獵積膚廠簾齋醖願壓鹹繭膚簾 (鹽蓋糧餘願顧繭窪願繭 ) 更多	-	2009-05-20
ASCO2008	临床1期	胰腺癌	4	Nafamostat mesilate + Gemcitabine	糧壓構壓醖積獵膚衊遞(餘鹹窪膚襯鹹壓範觸選) = 構窪鹽繭鹽簾範選襯觸齋範積積憲簾願簾醖餘 (簾選鹽鏇膚衊鏇鏇觸窪 ) 更多	积极	2008-05-20