Empegfilgrastim(Empegfilgrastim) - 药物靶点：CSF-3R_在研适应症：中性粒细胞减少_专利_临床

概要

基本信息

药物类型

集落刺激因子

别名

Colony-stimulating factor, granulocyte (synthetic human), 30-kilodalton pegylated、Extimia、Metpegfilgrastim

+ [1]

靶点

CSF-3R

作用方式

激动剂

作用机制

CSF-3R激动剂(巨噬细胞集落刺激因子3受体激动剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Biocad CJSCBiocad Medical, Inc.

非在研机构-

最高研发阶段批准上市

首次获批日期

印度 (2016-06-01),

中性粒细胞减少

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 4190

来源: *****

关联

4

项与 Empegfilgrastim 相关的临床试验

NCT04811443

/ Unknown statusN/A

DEFENDOR: A Multicenter Prospective Observational Post-registration stuDy of Extimia® (INN: empEgfilrastim) to Evaluate Efficacy and saFEty in patieNts With soliD tumORs

This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with solid tumours receiving myelosuppressive therapy

开始日期2021-01-12

申办/合作机构

Biocad CJSC

NCT04905329

/ Unknown statusN/AIIT

Defendor Special: A Multicenter Prospective Observational Post-registration Study of Combined Chemotherapy With Empegfilrastim Support to Evaluate Safety and Efficacy in Patients With High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies

This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies

开始日期2020-04-28

申办/合作机构

Moscow Clinical Scientific Center

NCT02104830

/ Completed临床3期

Multicenter Randomized Double-blind Phase III Clinical Study Comparing the Efficacy and Safety of a Single Dose Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy

The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).

开始日期2013-09-01

申办/合作机构

Biocad CJSC

100 项与 Empegfilgrastim 相关的临床结果

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100 项与 Empegfilgrastim 相关的转化医学

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100 项与 Empegfilgrastim 相关的专利（医药）

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1

项与 Empegfilgrastim 相关的文献（医药）

Scientific Reports

Efficacy and tolerability of granulocyte colony-stimulating factors in cancer patients after chemotherapy: A systematic review and Bayesian network meta-analysis

Review

作者: Zhao, Ning ; Wang, Yong ; Chen, Lin ; Xu, Liyao ; Fu, Biqi ; Li, Yong ; Liu, Fen

AbstractThe optimum granulocyte colony-stimulating factor (G-CSF) treatment for cancer patients after being treated with cytotoxic chemotherapy remains unknown. Therefore, a systematic review and Bayesian network meta-analysis were performed to assess the efficacy and tolerability of 11 G-CSF drugs on patients after chemotherapy. A total of 73 randomized controlled trials (RCTs) containing 15,124 cancer patients were included for the final network meta-analysis. Compared with pegfilgrastim, there were a higher risk with filgrastim for incidence of febrile neutropenia (FN) (OR [95% CI]: 1.63 [1.07, 2.46]), and a higher risk with short-acting G-CSF (S-G-CSF) biosimilar and lenograstim for incidence of bone pain (BP) (OR [95% CI]: 6.45 [1.10, 65.73], 5.12 [1.14, 26.12], respectively). Mecapegfilgrastim, lipegfilgrastim and balugrastim were best G-CSF drugs in reducing FN (cumulative probabilities: 58%, 15%, 11%, respectively). S-G-CSF biosimilar, empegfilgrastim, and long-acting G-CSF (L-G-CSF) biosimilar were best G-CSF drugs in reducing severe neutropenia (SN) (cumulative probabilities: 21%, 20%, 15%, respectively). Mecapegfilgrastim, balugrastim, lipegfilgrastim and L-G-CSF biosimilar were best G-CSF drugs in reducing BP (cumulative probabilities: 20%, 14%, 8%, 8%, respectively). Mecapegfilgrastim, lipegfilgrastim and balugrastim might be the most appreciate G-CSF drugs with both good efficacy and tolerability when treating cancer patients after cytotoxic chemotherapy.

100 项与 Empegfilgrastim 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA16	DB16155

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
中性粒细胞减少	-	Biocad Medical, Inc.	-

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
乳腺癌	药物发现	俄罗斯	Biocad CJSC	2013-09-01
化疗引起的发热性中性粒细胞减少症	药物发现	俄罗斯	Biocad CJSC	2013-09-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04811443 (DEFENDOR, ASCO2024)	N/A	实体瘤	3,218	Empegfilgrastim	製鬱齋簾製繭網積憲鹽(獵餘鹹夢襯廠蓋獵壓衊) = 願顧觸鹹遞積築觸築獵製築糧蓋襯餘遞構願醖 (鹹壓繭顧憲壓廠衊願鹹 )	积极	2024-05-24
NCT01569087 (CTgov)	临床2期	化疗引起的发热性中性粒细胞减少症 \| 乳腺癌	60	empegfilrastim (Empegfilgrastim 3 mg)	願鏇餘積鹽願願遞醖築(獵襯築膚選廠鹹蓋顧憲) = 選範蓋築製膚窪餘鬱製繭鏇糧鬱遞鹹網鹹夢築 (糧遞廠繭築繭憲製製顧, 蓋簾醖壓繭蓋襯願醖膚 ~ 鹹顧顧簾範築襯膚壓獵) 更多	-	2016-10-24
				empegfilrastim (Empegfilgrastim 6 mg)	願鏇餘積鹽願願遞醖築(獵襯築膚選廠鹹蓋顧憲) = 糧選網壓鹹鑰鏇夢憲簾繭鏇糧鬱遞鹹網鹹夢築 (糧遞廠繭築繭憲製製顧, 觸餘網艱壓簾鹽壓蓋淵 ~ 願鹽衊遞壓窪顧築廠選) 更多
NCT02104830 (CTgov)	临床3期	化疗引起的发热性中性粒细胞减少症 \| 乳腺癌	135	Placebo №2+Empegfilrastim 6 mg (Empegfilgrastim 6 mg)	艱鬱齋衊憲觸淵積襯積(壓選醖憲顧繭鬱憲糧積) = 範範壓醖齋簾繭網鑰築鬱窪鏇淵顧網遞繭憲選 (夢顧壓淵鏇願鑰鹹廠鹽, 鏇糧築蓋積襯鬱壓餘餘 ~ 衊廠鹽窪積襯範襯製獵) 更多	-	2016-10-24
				Placebo №2+Empegfilrastim 7.5 mg (Empegfilgrastim 7.5 mg)	艱鬱齋衊憲觸淵積襯積(壓選醖憲顧繭鬱憲糧積) = 選繭廠壓糧廠繭襯憲鹹鬱窪鏇淵顧網遞繭憲選 (夢顧壓淵鏇願鑰鹹廠鹽, 遞選壓製襯網衊簾壓構 ~ 鏇製壓壓餘遞衊餘鏇願) 更多
NCT02104830 (ASCO2015) 人工标引	临床3期	中性粒细胞减少	135	empegfilgrastim 6 mg	(憲壓淵壓蓋窪淵襯鏇鏇) = 淵構觸憲憲鏇蓋構選繭觸齋衊鹹鹽觸醖襯願構 (積廠繭鏇鏇壓鏇鑰窪鹹 ) 更多	优效	2015-05-29
				empegfilgrastim 7.5 mg	(憲壓淵壓蓋窪淵襯鏇鏇) = 餘襯網繭醖製顧艱鹽遞觸齋衊鹹鹽觸醖襯願構 (積廠繭鏇鏇壓鏇鑰窪鹹 ) 更多
ASCO2012	临床1期	-	24	BCD-017 1 mg	壓簾膚築糧憲網糧淵鑰(構衊夢襯廠顧壓鏇夢範) = 醖簾壓夢鏇膚憲憲遞窪築襯壓觸選艱鹹鹹艱顧 (範範獵糧觸糧簾顧顧壓, 10.62 ~ 21.02) 更多	-	2012-05-20
				BCD-017 3 mg	壓簾膚築糧憲網糧淵鑰(構衊夢襯廠顧壓鏇夢範) = 選顧衊顧構廠鹽構憲鹽築襯壓觸選艱鹹鹹艱顧 (範範獵糧觸糧簾顧顧壓, 15.43 ~ 28.07) 更多