阿法依伯汀生物类似药(Blau Farmacêutica SA)(Epoetin alfa biosimilar(Blau Farmacêutica SA)) - 药物靶点：EPO receptor_在研适应症：贫血_专利_临床

概要

基本信息

药物类型

生物类似药、集落刺激因子

别名

Eritromax

靶点

EPO receptor

作用方式

激动剂

作用机制

EPO receptor激动剂(促红细胞生成素受体激动剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

巴西 (2012-01-01),

贫血

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

结构/序列

Sequence Code 9003

当前序列信息引自: *****

关联

2

项与阿法依伯汀生物类似药(Blau Farmacêutica SA) 相关的临床试验

NCT01695759

/ Terminated临床3期

Evaluation of Clinical Efficacy and Immunogenicity of Drug Eritromax® at Blau Farmacêutica S.A. Compared to Eprex®, Produced by Janssen-Cilag Laboratory in Participants With Secondary Anemia to Chronic Kidney Disease.

This is a prospective, randomized, multicenter, parallel, placebo-controlled, phase III study for evaluation of clinical efficacy and immunogenicity of drug Eritromax® - (rHuEPO Blau Farmacêutica S/A.) compared to Eprex® (Janssen-Cilag rHuEPO) for the treatment of patients with secondary anemia to chronic kidney disease (CKD), throughout the correction phase by assessing the change in hemoglobin levels.

开始日期2013-12-01

申办/合作机构

Azidus Brasil

[+1]

NCT03572647

/ Completed临床1期

Randomized Clinical Study for Pharmacokinetics and Pharmacodynamics Assessment of Drug Eritromax, Marketed by the Blausiegel Laboratory, Compared to Drug Eprex, Produced by Janssen-Cilag Laboratory, in Healthy Subjects.

The epoetin is a glycoprotein and endogenous hormone, which is primarily synthesized by specific epithelial cells lining the kidney peritubular capillaries, and regulates continuous formation of red blood cells. This is a pharmacokinetics and pharmacodynamics study, in which each subject will receive the investigational product in different periods, as randomisation (Teste or Comparator). The evaluation of the profile included serum dosage of medications and reticulocyte count in peripheral blood.

开始日期2012-11-01

申办/合作机构

Azidus Brasil

[+1]

100 项与阿法依伯汀生物类似药(Blau Farmacêutica SA) 相关的临床结果

登录后查看更多信息

100 项与阿法依伯汀生物类似药(Blau Farmacêutica SA) 相关的转化医学

登录后查看更多信息

100 项与阿法依伯汀生物类似药(Blau Farmacêutica SA) 相关的专利（医药）

登录后查看更多信息

100 项与阿法依伯汀生物类似药(Blau Farmacêutica SA) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	B03XA01	-

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
贫血	巴西	Blau Farmacêutica SA	2012-01-01

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
伴随慢性肾病的贫血	药物发现	巴西	Blau Farmacêutica SA	2013-12-01
自身免疫性溶血性贫血	药物发现	巴西	Blau Farmacêutica SA	2013-12-01