头孢羟氨(Cefadroxil) - 药物靶点：PBPs_在研适应症：细菌感染_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Berberine Hydrochjoride and Trimethoprim、Berberine Hydrochlonide and Trimethoprim、Berberine Hydrochloride and Trimethoprim

+ [23]

靶点

PBPs

作用方式

抑制剂

作用机制

PBPs抑制剂(细菌青霉素结合蛋白家族抑制剂)、细胞壁抑制剂

治疗领域

感染

在研适应症

细菌感染

非在研适应症

A组链球菌性咽炎咽炎皮肤和皮肤结构感染+ [2]

原研机构

在研机构

+ [1]

非在研机构

Warner Chilcott, Inc.

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (1978-02-17),

细菌感染

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C16H17N3O5S

InChIKeyBOEGTKLJZSQCCD-UEKVPHQBSA-N

CAS号50370-12-2

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关联

42

项与头孢羟氨相关的临床试验

NCT06406114

/ Not yet recruiting临床2期IIT

Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing

Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.

开始日期2025-04-15

申办/合作机构

The General Hospital Corp.

[+1]

CTR20250738

/ CompletedN/A

头孢羟氨苄干混悬剂的单中心、随机、开放、双制剂、双周期、双序列、交叉生物等效性试验

主要研究目的评价中国健康成年研究参与者空腹及餐后条件下单次单剂量口服头孢羟氨苄干混悬剂受试制剂（规格：500mg/5mL，申办者：苏州第三制药厂有限责任公司）和参比制剂（商品名：Cefadroxil®，规格：500mg/5mL，持证商：Lupin Pharmaceuticals, Inc.）后的药代动力学特点和生物等效性。次要研究目的研究头孢羟氨苄干混悬剂受试制剂（规格：500mg/5mL）和参比制剂（商品名：Cefadroxil®，规格：500mg/5mL）在中国健康成年研究参与者中的安全性。

开始日期2025-04-01

申办/合作机构

苏州第三制药厂有限责任公司

CTR20250429

/ RecruitingN/A

中国健康受试者空腹和餐后口服STBB的随机、开放、两序列、两周期、双交叉设计的生物等效性试验

研究空腹和餐后状态下单次口服受试制剂头孢羟氨苄干混悬剂（规格：500mg/5mL，生产单位：四川赛卓药业股份有限公司）与参比制剂头孢羟氨苄干混悬剂（规格：500mg/5mL，持证商：LUPIN LTD），在健康成年受试者体内的药代动力学，评价空腹和餐后口服两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹和餐后状态下，单次口服受试制剂头孢羟氨苄干混悬剂和参比制剂头孢羟氨苄干混悬剂后的安全性。

开始日期2025-02-24

申办/合作机构

广东万泰科创药业有限公司

100 项与头孢羟氨相关的临床结果

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100 项与头孢羟氨相关的转化医学

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100 项与头孢羟氨相关的专利（医药）

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2,430

项与头孢羟氨相关的文献（医药）

2025-05-01·Laboratory Investigation

Clinical Use of Liquid-Based Comprehensive Genomic Profiling in Gastrointestinal Stromal Tumors

Article

作者: Saiji, Essia ; Huang, Richard S P ; Haberberger, James ; Elvin, Julia A ; Hildebrand, Lindsey ; Koessler, Thibaud ; Madison, Russell ; Tukachinsky, Hanna ; Marks, Eric ; Lin, Douglas I ; Killian, Jonathan K ; Sivakumar, Smruthy ; Mechahougui, Hiba ; Heinrich, Michael C

Treatment for gastrointestinal stromal tumor (GIST) focuses on tyrosine kinase inhibitors, the selection of which depends on specific mutations. We sought to determine the clinical use of liquid biopsy in advanced GIST. Liquid (n = 181) (FoundationOne Liquid CDx) and tissue (n = 2198) (FoundationOne and FoundationOne CDx) comprehensive genomic profiling of GIST were evaluated. The presence of circulating tumor DNA in liquid was determined via tumor fraction (TF), with an elevated TF defined as TF ≥ 1%. Liquid comprehensive genomic profiling revealed 30% (54/181) of samples had an elevated TF, among which the prevalence of KIT and PDGFRA alterations were 89% (48/54) and 2% (1/54), respectively. In patient-matched tissue/liquid samples (n = 49), the positive percent agreement of driver alterations in liquid with an elevated TF relative to tissue was 100%. Fifty-five percent (42/77) of liquid samples with a KIT driver mutation had a co-occurring imatinib-resistant alteration; a minority of cases harbored non-KIT mechanisms of resistance such as FGFR2 fusions and BRAF or EGFR alterations. The relative prevalence of imatinib resistance KIT exon 13 and 17 mutations was enriched in liquid compared with tissue. Finally, in the liquid cohort, 2.2%, 1.7%, and 1.1% of patients were predicted to harbor germline KIT, SDHx, or NF1 mutations, respectively. In conclusion, known driver and tyrosine kinase inhibitor--resistant mutations were identified in liquid biopsies of patients with GIST with high concordance to tissue in the presence of an elevated TF. Liquid biopsy may be valuable in the molecular classification and medical management of GIST.

2025-04-01·Journal of Chromatography B

Identification, synthesis, isolation, and characterization of formulation related degradation impurity of Cefadroxil Oral suspension

Article

作者: Trivedi, Anurag ; Vasantharaju, Surenehalli Gowdra ; Murkute, Sunil Ramrao ; Upadhyay, Pritesh R ; Bhat, Krishnamurthy ; Singh, Girij P ; Godbole, Himanshu M

Cefadroxil is an orally active, first-generation cephalosporin antibiotic utilized in the treatment of bronchitis, pharyngitis, tonsillitis, urinary tract infections, uncomplicated skin infections, bones, and joints (de Marco and Salgado, 2017 [1]). Cefadroxil for oral suspension is formulated as dry powder for oral suspension. After reconstitution during 14 days storage, we observed an unknown impurity at relative retention time (RRT) 1.29 in cefadroxil oral suspension. The observed level of an unknown impurity was greater than 0.1 % in high-performance liquid chromatography (HPLC) analysis. The present work is focused on the identification, synthesis, and characterization of the unknown impurity by employing several sophisticated analytical techniques. Such as High-resolution mass spectroscopy (HRMS), One dimensional (1D) and two dimensional (2D) nuclear magnetic resonance spectroscopy.

2025-03-01·Journal of Chromatography A

Predicting retention on immobilized artificial membrane chromatography: Lipophilicity-based versus lipophilicity-independent models

Article

作者: Tsantili-Kakoulidou, Anna ; Vallianatou, Theodosia ; Tsopelas, Fotios

Retention of molecules on immobilized artificial membrane (IAM) chromatography is a key physicochemical property for predictive models of permeability across biological barriers, with applications in drug design and ecotoxicology. Currently, IAM retention is solely experimentally determined, which limits its utility for screening virtual compound libraries or for predictions of yet not synthesized molecules. The present study focuses on developing predictive models of IAM retention factors (logk_w(IAM)) for a structurally diverse set of drug compounds, scrutinizing the role of lipophilicity, experimental and calculated, as well as the contribution of additional molecular parameters, selected from a pool of physicochemical, constitutional, topological and 3D descriptors. After obtaining a data overview by principal component analysis, both multiple linear regression (MLR) and partial least squares (PLS) analyses were used to construct lipophilicity-based models and lipophilicity-independent models. Bulk, polarity and fraction of anionic species were common descriptors in all models. It was demonstrated that calculated lipophilicity values introduced additional uncertainty, depending on the software used. On the other hand, lipophilicity-independent MLR and PLS models, which relied solely on computational descriptors, showed comparable performance with lipophilicity-based models, while offering the advantage to more useful for screening large libraries in early drug discovery. The reliability of lipophilicity-independent MLR and PLS models was assessed by external validation as well as by using a blind test set. Error distribution between lipophilicity-based and lipophilicity-independent models was also investigated and found to be comparable, while it was better than the differences between experimental and calculated lipophilicity values.

516

项与头孢羟氨相关的新闻（医药）

2025-05-02

·PRNewswire

CDx Diagnostics to Present WATS3D Progression Data at DDW 2025

Highlights Continued Progress in Early Detection and the Progression of Esophageal Disease SUFFERN, N.Y., May 2, 2025 /PRNewswire/ -- CDx Diagnostics announced today that new clinical data supporting the utility of the WATS3D test for Barrett's esophagus and dysplasia screening and surveillance has been selected for podium presentation at the 2025 Digestive Disease Week (DDW) in San Diego, the premier conference for gastroenterology professionals. This podium presentation, along with additional data featured in a separate poster presentation, highlights WATS3D's vital role in early detection, progression monitoring and risk assessment of patients at risk for Barrett's esophagus and esophageal cancer. Continue Reading WATS3D has consistently shown superior detection rates compared to conventional forceps biopsy (FB), the latter of which can miss up to 50% of cases. By sampling a broader area of mucosa and analyzing more cellular material using advanced 3D imaging, WATS3D may help gastroenterologists detect Barrett's esophagus that might otherwise go undiagnosed. New DDW 2025 data reveal WATS3D's enhanced capabilities for Barrett's detection, surveillance and risk assessment. Post this Key Events at DDW 2025: Podium Presentation: "Progression Rates of Barrett's Esophagus and Dysplasia Detected by WATS3D Are Similar to Those Diagnosed by Forceps Biopsies" Poster Presentation: "MUC2 Immunostaining Predicts Neoplastic Progression as Accurately as the Presence of Goblet Cells in Columnar-Lined Esophagus: A WATS3D Study of 3,553 Patients" Nicholas J. Shaheen, MD will deliver the podium presentation, based on a collaborative study with Dr. Michael Smith, Dr. Vivek Kaul, Mendel Singer Ph.D., and Dr. Robert Odze. "The findings validate WATS3D's role in early detection," said Dr. Shaheen. "We're excited to share these results at DDW and discuss their impact on patient care." Robert D. Odze, MD noted that "These studies advance our understanding of the biological significance of WATS3D detected lesions and their risk of progression to cancer in Barrett's esophagus." The new data shared at DDW 2025 from May 3-6 offers important clinical insights into the evolving role of WATS3D in Barrett's detection, surveillance and risk assessment. For more information, visit or contact us at [email protected]. About CDx Diagnostics CDx Diagnostics' mission is to Empower Physicians with Innovative Technology to Prevent Esophageal Cancer, One Patient at a Time. The company's proprietary diagnostic platform combines advanced computer imaging, artificial intelligence, molecular biology, and 3D cytopathology to detect precancerous changes earlier and more precisely than conventional methods. This pioneering solution has analyzed over 400,000 cases, empowering providers to identify those requiring early intervention, reduce time to treatment, and improve outcomes by detecting disease that might be missed by traditional forceps biopsies. CONTACT: Logan Garrett [email protected] 423-519-9979 SOURCE CDx Diagnostics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

诊断试剂

2025-05-01

·Pharma CMC

这款重磅首仿药官宣今日降价，幅度不低于35%！

4月30日，上海复旦张江生物医药股份有限公司发布公告，其抗肿瘤药物盐酸多柔比星脂质体注射液（商标名：里葆多®），自2025年5月1日起按照各省份对于未中选产品的规则和要求，陆续调整、梯度降低该药物的市场零售价格，相比此前中标价格降价幅度不低于35%。里葆多®为楷莱®（Doxil®/Caelyx®）的国内首仿药，是国内外首个纳米药物的仿制药物。该药物是一种采用先进的隐形脂质体技术包封，具有被动靶向特性的多柔比星新剂型，它是蒽环类药物的更新换代产品，在肿瘤治疗学上具有提高疗效、降低心脏毒性、骨髓抑制以及减少脱发等优势。该药物主要用于与艾滋病相关的卡波氏肉瘤，亦可用于多发性骨髓瘤、乳腺癌和卵巢癌等肿瘤的治疗。2024年，盐酸多柔比星脂质体注射液首次被纳入国家集采目录，中选厂家分别为石药欧意、浙江圣兆药物（海正药业受托生产）、齐鲁制药（海南）以及常州金远药业，最低价为石药集团的98元，较限价降幅约89%。据复旦张江公告披露，2024年，里葆多®销售收入约为人民币2.1亿元，占公司全年销售收入的29%。该药物（规格：10ml:20mg）于部分省（自治区、直辖市）中标价格区间为3039.60元/瓶至3951.95元/瓶，医疗机构全年实际采购量合计为72,118瓶。复旦张江表示，依据第十批集采的规则以及市场竞争格局的改变，将导致该药物的销售策略和销售价格需要在执行期间进行调整。而本次价格调整后，预计对该药物2025年第二季度及后续执行期间的销售收入产生不利影响。鉴于该药物价格调整及本次集采未中选后销售量下滑等因素，预计将导致该药物2025年度销售收入同比下降。

带量采购一致性评价生物类似药

2025-04-29

·米内网

【瞩目】30亿大品种，山东药企过评了

精彩内容4月29日，新华制药发布公告，其阿司匹林肠溶片新增规格（100mg）及通过仿制药一致性评价。米内网数据显示，阿司匹林肠溶片在近年中国三大终端六大市场（统计范围见文末）均保持30亿元以上的销售规模，2024年上半年同比增长3.36%，是抗血栓形成药（化+生）TOP2产品。截至目前，新华制药通过/视同通过一致性评价品种超过60个。阿司匹林肠溶片临床上主要用于不稳定性心绞痛（标准治疗的一部分）；急性心肌梗死（标准治疗的一部分）；预防心肌梗死复发；动脉血管手术或介入手术后，如主动脉冠状动脉静脉搭桥术、经皮冠状动脉腔内血管成形术；预防短暂性脑缺血发作（TIA）和已出现早期症状后预防脑梗死。近年中国三大终端六大市场阿司匹林肠溶片销售情况（单位：万元）来源：米内网格局数据库阿司匹林肠溶片在近年中国三大终端六大市场均保持30亿元以上的销售规模，2024年上半年同比增长3.36%，是抗血栓形成药（化+生）TOP2产品，拜耳的市场份额最大。米内网数据显示，阿司匹林肠溶片有231家企业拥有生产批文，山东新华制药、石药欧意药业、重庆药友制药等18家企业过评，天方药业和广东彼迪药业的一致性评价补充申请在审，华中药业、山西复盛公大药厂、石家庄华新药业等8家企业以仿制4类报产在审，获批后视同过评。同日，新华制药发布公告，北京民康百草医药的甲钴胺片上市许可持有人变更为新华制药。新华制药表示，公司成为该产品的上市许可持有人，有利于丰富公司神经系统药物产品线，提升公司综合竞争优势。在此之前，公司的盐酸美金刚口服溶液和普瑞巴林口服溶液同日获批，并视同过评；广西大海阳光药业的艾司唑仑片上市许可持有人更为新华制药；氨茶碱片的一致性评价补充申请获批。截至目前，新华制药通过/视同通过一致性评价品种超过60个，涵盖神经系统药物、呼吸系统用药、消化系统及代谢药等治疗大类。资料来源：国家药监局官网、米内网数据库注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

一致性评价上市批准

100 项与头孢羟氨相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	头孢羟氨	J01DB05	DB01140

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
细菌感染	中国	牡丹江灵泰药业股份有限公司	1986-01-01
细菌感染	中国	黑龙江诺捷制药有限责任公司	1986-01-01
细菌感染	中国	葵花药业集团股份有限公司	1986-01-01
细菌感染	中国	哈药集团股份有限公司	1986-01-01

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临床结果

适应症

分期

评价

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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


1466 (SITC2024)	临床1/2期	黑色素瘤辅助 BRAF-V600E	-	Vaccine [6MHP + neoAg-mBRAF + polyICLC] with CDX-1140 50 mcg	壓餘醖網蓋醖鏇範獵襯(醖繭糧襯餘製顧鑰醖廠) = limited to Grade 1 or 2 treatment-related adverse events, with no treatment-related dose-limiting toxicities 顧鹽鹹鏇鬱簾夢餘繭醖 (餘選鑰鹽繭鏇鏇鬱蓋網 )	积极	2024-11-05
				Vaccine [6MHP + neoAg-mBRAF + polyICLC] with CDX-1140 200 mcg
DDW2024	N/A	腺瘤	-	Compound Berberine Hydrochloride	繭獵遞廠鹽鹽餘憲築鏇(糧簾顧鏇遞鹽積糧壓獵) = 膚餘網鬱顧艱繭遞衊築選願繭膚糧鏇壓夢壓壓 (餘顧餘願夢積鏇衊膚遞 )	积极	2024-05-19
AAAAI2024	N/A	过敏	-	Cefazolin	憲夢衊製繭膚憲夢廠鏇(網選鑰範鹹醖鹽齋願製) = 鹹簾簾網鏇壓構網鹽築鬱艱餘壓醖淵簾遞構鬱 (鹹獵齋壓遞艱築窪範選 )	-	2024-02-23
				Cefoxitin	憲夢衊製繭膚憲夢廠鏇(網選鑰範鹹醖鹽齋願製) = 餘鬱艱構鏇鑰醖壓餘夢鬱艱餘壓醖淵簾遞構鬱 (鹹獵齋壓遞艱築窪範選 )
DDW2022	N/A	转移性胰腺癌	-	Berberine	鹽鏇獵廠構製範選鬱齋(鏇壓艱衊範蓋願鑰衊膚) = 繭壓獵顧鬱網網衊顧簾選鏇鹽獵餘壓夢餘壓簾 (鑰夢鏇鑰蓋餘齋鹽築鹽 )	积极	2022-05-24
				Vehicle	鹽鏇獵廠構製範選鬱齋(鏇壓艱衊範蓋願鑰衊膚) = 鬱願衊製獵衊選範憲觸選鏇鹽獵餘壓夢餘壓簾 (鑰夢鏇鑰蓋餘齋鹽築鹽 )
Tandem Meetings ASTCT and CIBMTR2013	临床1期	-	30	CDX-301 1 mcg/kg	齋糧醖繭襯襯鏇觸製餘(製獵築鏇艱壓艱糧遞構) = one HV with a remote history of community acquired pneumonia was hospitalized with community acquired pneumonia which developed on study day 12; the event responded rapidly to antibiotic treatment and fully recovered within 2 weeks, but was considered a dose-limiting toxicity given the temporal association with CDX-301 administration 積繭獵簾醖築簾鑰構膚 (夢壓遞蓋選鬱製膚糧膚 )	积极	2013-02-01
				CDX-301 3 mcg/kg
NCT00834275 (CTgov)	临床1期	-	26	Cefadroxil (Cefadroxil (Test))	(齋衊廠繭窪鏇蓋鑰範繭) = 鑰獵遞範觸鑰鬱鏇獵遞膚製願襯遞憲窪製觸窪 (蓋壓鑰願艱鬱鏇網餘餘, 鏇齋襯餘觸遞醖齋鑰膚 ~ 觸選構壓窪鹹選鏇憲鹹) 更多	-	2009-07-21
				Duricef (Duricef® (Reference))	(齋衊廠繭窪鏇蓋鑰範繭) = 醖衊鬱構鏇獵憲製糧築膚製願襯遞憲窪製觸窪 (蓋壓鑰願艱鬱鏇網餘餘, 積選醖遞鹽鏇範淵艱齋 ~ 窪繭糧衊夢獵鬱鹹願淵) 更多
NCT00835081 (CTgov)	临床1期	-	26	Cefadroxil (Cefadroxil (Test))	(壓廠醖齋蓋築夢窪範夢) = 鏇糧衊獵襯築觸築衊範鹹淵繭鹽鏇繭範襯襯艱 (簾觸簾壓廠壓艱顧範繭, 廠壓選壓築廠繭襯簾積 ~ 廠鏇網醖窪糧鹽簾鏇夢) 更多	-	2009-07-21
				Duricef (Duricef® (Reference))	(壓廠醖齋蓋築夢窪範夢) = 製鏇獵醖選製構願餘膚鹹淵繭鹽鏇繭範襯襯艱 (簾觸簾壓廠壓艱顧範繭, 積糧壓網糧簾糧築蓋觸 ~ 鹽構鏇鑰憲艱膚選積廠) 更多