吉莫斯特(Gimeracil) - _专利_临床

概要

基本信息

药物类型

小分子化药

别名

5-Chloro-2,4-dihydroxypyridine、5-Chloro-4-hydroxy-2-pyridone、Gimeracil (JAN/INN)

+ [3]

靶点-

作用机制-

治疗领域-

在研适应症-

非在研适应症-

原研机构-

在研机构

山东新时代药业有限公司

非在研机构-

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)批准上市

特殊审评特殊审批 (中国)

结构

分子式C5H4ClNO2

InChIKeyZPLQIPFOCGIIHV-UHFFFAOYSA-N

CAS号103766-25-2

关联

130

项与吉莫斯特相关的临床试验

ChiCTR2400086933 / Recruiting临床3期IIT

A multicenter, randomized, phase III clinical study comparing the combination of radiotherapy with Tegafur, Gimeracil, and Oteracil Potassium (TS-1) and Tislelizumab to the combination of radiotherapy with TS-1 in elderly patients with locally advanced esophageal squamous cell carcinoma. - A multicenter, randomized, phase III clinical study comparing the combination of radiotherapy with Tegafur, Gimeracil, and Oteracil Potassium (TS-1) and Tislelizumab to the combination of radiotherapy with TS-1 in elderly patients with locally advanced esophageal squamous cell carcinoma.

开始日期2024-03-01

申办/合作机构

河南省肿瘤医院

NCT04172402 / Active, not recruiting临床2期IIT

A Study of Nivolumab Combination Gemcitabine and S1 as the First-Line Treatment in Patients With Advanced Biliary Tract Cancer

To evaluate disease objective response rate (ORR) of nivolumab in combination with gemcitabine and TS1 in patients with advanced biliary tract cancer

开始日期2019-12-27

申办/合作机构

National Taiwan University Hospital

[+5]

JPRN-UMIN000043646 / RecruitingIIT

Long term follow-up protocol of Peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patients phase 2 study - Long term follow-up of GAPS study

开始日期2019-09-01

申办/合作机构

Kindai University

100 项与吉莫斯特相关的临床结果

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100 项与吉莫斯特相关的转化医学

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100 项与吉莫斯特相关的专利（医药）

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590

项与吉莫斯特相关的文献（医药）

2024-07-01·Gastric Cancer

Adjuvant and post-recurrent treatment patterns in patients with resectable gastric cancer in Japan: a retrospective database cohort study

Article

作者: Hironaka, Shuichi ; Matsuda, Yuko ; Nishiyama, Eiji ; Casaes Teixeira, Bruno ; Kimijima, Yuya ; Tejada, Mariella ; Carroll, Robert ; Yoshikawa, Takaki ; Kikko, Yorifumi ; Makino, Reina

AbstractBackgroundThis study examined temporal shifts in adjuvant therapy patterns in Japanese patients with resectable gastric cancer (GC) and treatment patterns of first-line and subsequent therapy among those with recurrent disease.MethodsThis retrospective analysis of hospital-based administrative claims data (April 1, 2008 to March 31, 2022) included adults (aged ≥ 20 years) with GC who started adjuvant therapy on or after October 1, 2008 (adjuvant cohort) and patients in the adjuvant cohort with disease recurrence (recurrent cohort), further defined by the time to recurrence (≤ 180 or > 180 days after adjuvant therapy).ResultsIn the adjuvant cohort (n = 17,062), the most common regimen during October 2008–May 2016 was tegafur/gimeracil/oteracil potassium (S-1; 95.7%). As new standard adjuvant regimen options were established, adjuvant S-1 use decreased to 65.0% and fluoropyrimidine plus oxaliplatin or docetaxel plus S-1 use increased to 15.0% and 20.0%, respectively, in September 2019–March 2022. In the recurrent cohort with no history of trastuzumab/trastuzumab deruxtecan treatment (n = 1257), the most common first-line regimens were paclitaxel plus ramucirumab (34.0%), capecitabine plus oxaliplatin (CapeOX; 17.0%), and nab-paclitaxel plus ramucirumab (10.1%) in patients with early recurrence, and S-1 plus oxaliplatin (26.3%), S-1 plus cisplatin (15.3%), CapeOX (14.0%), S-1 (13.2%), and paclitaxel plus ramucirumab (10.8%) in those with late recurrence.ConclusionsThis study demonstrated temporal shifts in adjuvant treatment patterns that followed the establishment of novel regimens, and confirmed that post-recurrent treatment patterns were consistent with the Japanese Gastric Cancer Association guideline recommendations.

2024-07-01·Gastric Cancer

Molecular features and prognostic factors of locally advanced microsatellite instability-high gastric cancer

Article

作者: Terashima, Masanori ; Bando, Etsuro ; Koseki, Yusuke ; Urakami, Kenichi ; Tanizawa, Yutaka ; Fujiya, Keiichi ; Hatakeyama, Keiichi ; Yamaguchi, Ken ; Furukawa, Kenichiro

BACKGROUNDMicrosatellite instability-high (MSI-H) tumors are distinct molecular subtypes in gastric cancer. However, a few studies have comprehensively reported the molecular features of MSI-H tumors and their prognostic factors in locally advanced gastric cancer. This study aimed to clarify the molecular features and prognostic factors of locally advanced MSI-H gastric cancer.METHODSThis study included 499 patients with locally advanced gastric cancer who underwent radical gastrectomy. We evaluated the MSI status and compared with previously published whole-exome sequencing, panel sequencing, and gene expression profiling data. Clinicopathological characteristics and molecular profiles were compared between patients with MSI-H and microsatellite stable (MSS) gastric cancer. A subgroup analysis of survival was performed in patients with MSI-H gastric cancer.RESULTSMSI-H tumors were detected in 79 of 499 patients (15.8%). MSI-H tumors were associated with an increased tumor mutational burden, MLH1 downregulation, CD274 (PD-L1) upregulation, and enrichment of cell cycle pathways. Among patients with MSI-H gastric cancer, the disease-specific survival (DSS) tended to be better in the surgery plus tegafur, gimeracil, and oteracil potassium (S-1) adjuvant chemotherapy group than in the surgery alone group, especially for stage III patients. Furthermore, DSS was better in the T cell-inflamed gene expression signature-high group, and it tended to be worse in the non-solid type poorly differentiated adenocarcinoma group.CONCLUSIONSThe molecular features and prognostic factors of locally advanced MSI-H gastric cancer were clarified. S-1 adjuvant chemotherapy appears to be beneficial, and the T cell-inflamed gene expression signature and histopathological type are prognostic factors in MSI-H tumors.

2024-07-01·Breast Cancer Research and Treatment

Treatment patterns and clinical outcomes in patients with metastatic triple-negative breast cancer: a large-scale data analysis using the Japanese claims database

Article

作者: Ntalla, Ioanna ; Saji, Shigehira ; Piao, Yi ; Takami, Tomoko ; Kimura, Takayuki

AbstractPurposeThis study evaluated treatment patterns and clinical outcomes among patients with metastatic triple-negative breast cancer (mTNBC) in real-world clinical settings in Japan.MethodsThe treatment patterns, time to next treatment or death (TTNTD), time to treatment discontinuation, adverse events of interest, and medical costs of treating patients with mTNBC in first-, second-, and third-line settings were investigated using data of patients meeting the inclusion criteria between January 2017 and March 2022 in a Japanese medical claims database. The treatment regimens for mTNBC were defined according to the Japanese Breast Cancer Society Clinical Practice Guidelines.ResultsIn this study, 2236 patients with mTNBC (median age 66.0 years; 99.8% female) were included in the first-line cohort. Of these, 46.6% and 20.8% were included in the second- and third-line cohorts, respectively. The two most frequently used treatments were capecitabine (19.1%) and S-1 (tegafur–gimeracil–oteracil) (14.5%) in the first-line cohort, eribulin (18.3%) and bevacizumab/paclitaxel (14.4%) in the second-line cohort, and eribulin (19.4%) and bevacizumab/paclitaxel (17.5%) in the third-line cohort. The TTNTD shortened as the line of therapy progressed (median 8.0, 6.5, and 5.2 months for the first-, second-, and third-line treatments, respectively). Nausea/vomiting and neutropenia/leukopenia occurred in 62.8% and 18.3% of all patients, respectively. The medical total costs per day were 6.7, 10.2, and 12.9 thousand yen during the first-/second-/third-line treatments, respectively.ConclusionThis study provides insight into current treatment patterns for mTNBC in Japan. The cost–benefit balance worsens with later-line treatment and a high unmet need for mTNBC drug treatment remains.

1

项与吉莫斯特相关的新闻（医药）

2024-03-04

·米内网

【重磅】扬子江拿下超12亿大品种，今年第二款新品

精彩内容3月1日NMPA官网发布最新药品获批信息，扬子江药业集团的替吉奥胶囊获批上市。替吉奥是一款畅销抗肿瘤药，2022年在中国三大终端六大市场（统计范围见文末）的合计销售额在12亿元以上。替吉奥胶囊早前已有3家国内药企获批，扬子江药业集团为第四家。图1：扬子江药业集团最新获批的产品来源：NMPA官网替吉奥是由替加氟、吉美嘧啶和奥替拉西钾三种成分组成的复方抗恶性肿瘤药物，属于新型氟尿嘧啶类衍生物，用于治疗不能切除的局部晚期或转移性胃癌。图2：早前国内市场已上市的替吉奥制剂来源：米内网中国上市药品（MID）数据库已上市的替吉奥制剂有替吉奥胶囊和替吉奥片，早前替吉奥胶囊已有齐鲁制药、江苏恒瑞医药、山东新时代药业获批并视同过评，扬子江药业集团是该产品的国产第四家（获批+过评）企业。图3：替吉奥在网上药店终端的销售情况（单位：万元）来源：米内网中国网上药店药品终端竞争格局2022年在中国三大终端六大市场，替吉奥的合计销售额在12亿元以上，其中公立医院终端（城市公立医院+县级公立医院）是销售主战场，该品种近几年在中国网上药店终端的销售额持续暴涨，潜力不容小觑，最新数据显示，2023年在中国网上药店终端替吉奥的销售额突破了1700万元。2024年1月9日，扬子江药业旗下江苏海岸药业的泊沙康唑肠溶片获批上市，成为了集团今年首款上市的新品，本次获批的替吉奥胶囊则为集团再添喜讯。图4：扬子江药业集团今年以来申报上市的新产品来源：米内网中国申报进度（MED）数据库米内网数据显示，今年以来扬子江药业集团已提交了西甲硅油乳剂和注射用醋酸西曲瑞克的仿制上市申请，两个产品2022年在中国三大终端六大市场的合计销售额均超过3亿元。目前西甲硅油乳剂仅有原研+3家国内药企获批，竞争未算十分激烈，注射用醋酸西曲瑞克则有原研+5家国内药企获批。资料来源：NMPA官网、米内网数据库等注：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。数据统计截至3月4日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，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

上市批准

100 项与吉莫斯特相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01846	-	-	DB09257

研发状态

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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


Pubmed 人工标引	N/A	局部进展期胃癌新辅助	96	Apatinib+Tegafur+Gimeracil+Oteracil+Oxaliplatin	(繭窪簾築壓選鏇夢艱餘) = the incidences of adverse events between the two groups were not different 願顧製鏇膚襯繭簾窪觸 (築顧網簾積膚繭選鹽衊 ) 更多	积极	2022-07-11
Pubmed 人工标引	N/A	局部进展期胃癌新辅助	96	Oxaliplatin+Capecitabine		积极	2022-07-11
JPRN-C000000416 (SELECT BC, ASCO2014)	临床3期	转移性乳腺癌一线	-	Taxane	(範選觸選遞製繭構淵壓) = 鹽夢鹹範醖構夢齋獵鑰願夢衊廠衊觸窪鬱壓襯 (製廠艱觸齋簾廠醖鑰淵 ) 更多	积极	2014-05-20
JPRN-C000000416 (SELECT BC, ASCO2014)	临床3期	转移性乳腺癌一线	-	TS-1	(範選觸選遞製繭構淵壓) = 鏇齋範壓繭製醖膚夢繭願夢衊廠衊觸窪鬱壓襯 (製廠艱觸齋簾廠醖鑰淵 ) 更多	积极	2014-05-20
ASCO2012	N/A	局部晚期不可切除的胃腺癌	1,372	TS-1 monotherapy	(獵鏇襯襯築鹽簾鏇衊廠) = 蓋淵網獵醖蓋醖選夢製遞衊獵蓋築觸壓獵鬱膚 (艱廠範鬱顧鹽淵觸壓築, 10.6 ~ 17.9) 更多	-	2012-05-20
ASCO2012	N/A	局部晚期不可切除的胃腺癌	1,372	TS-1/cisplatin	(獵鏇襯襯築鹽簾鏇衊廠) = 憲獵顧簾鑰構鏇齋夢製遞衊獵蓋築觸壓獵鬱膚 (艱廠範鬱顧鹽淵觸壓築, 14.4 ~ 17.9) 更多	-	2012-05-20
ASCO2011	临床2期	HER2 阴性乳腺癌新辅助	48	Doxorubicin/cyclophosphamide (AC) followed by docetaxelDoxorubicin/cyclophosphamide (AC) followed by docetaxelDoxorubicin/cyclophosphamide (AC) followed by docetaxel and TS-1 (DS)	(夢構積積衊艱餘夢構衊) = 構遞範顧膚夢構襯膚繭壓糧淵範簾鏇鑰鬱鹹膚 (顧夢淵窪鹹觸夢鹽網窪 ) 更多	-	2011-05-20
ASCO2010	临床1/2期	晚期非小细胞肺癌	23	TS-1 monotherapy	(築網網衊壓積艱襯壓簾) = 遞膚鬱醖積鏇夢齋壓範窪觸觸膚網衊廠壓鑰願 (鏇觸繭夢壓鏇醖憲網範 ) 更多	积极	2010-05-20
ASCO2009	N/A	乳腺癌	40	TS-1	鏇鹹蓋簾製壓鬱積餘醖(積齋選製鏇顧遞構艱憲) = 6 of the 40 patients (15.0%) who received TS-1 did hand-foot syndrome (HFS), although 20 of the 40 patients (50.0%) who had received capecitabine, developed HFS. 製窪鏇鹽鏇鑰夢網壓積 (鑰鹽鬱築繭積蓋繭襯鏇 )	积极	2009-05-20
CJLSG0402 (ASCO2008)	临床1/2期	晚期非小细胞肺癌	-	TS-1 plus carboplatinTS-1 plus carboplatin	(鏇顧遞鹹範構蓋積膚構) = 鑰醖獵襯顧鬱願餘憲遞餘製鬱窪網夢繭遞鹹築 (遞齋築遞鏇鹹醖鬱簾餘 ) 更多	-	2008-05-20
ASCO2007	临床2期	非小细胞肺癌 III期	28	TS-1 plus cisplatin	(簾範築構淵糧淵鏇繭憲) = 網製鏇簾範醖鹹簾膚遞觸繭鑰獵壓襯襯獵網範 (糧餘膚膚築糧淵範繭遞, 79.1 ~ 98.7)	-	2007-06-20
ASCO2007	N/A	肿瘤	147	Concurrent radiation therapy combined with UFT	願窪繭網鹹觸構製餘觸(簾窪獵糧廠願襯襯積繭) = 艱網淵顧壓築築餘襯夢築鬱構製簾醖蓋窪積範 (鑰遞簾淵構顧艱廠餘醖 )	积极	2007-06-20
ASCO2007	N/A	肿瘤	147	Concurrent radiation therapy combined with TS-1	願窪繭網鹹觸構製餘觸(簾窪獵糧廠願襯襯積繭) = 獵醖選齋選繭遞淵鏇糧築鬱構製簾醖蓋窪積範 (鑰遞簾淵構顧艱廠餘醖 )	积极	2007-06-20