地舒单抗生物类似药 (Alkem Laboratories)(Denosumab biosimilar (Alkem Laboratories)) - 药物靶点：RANKL_在研适应症：绝经期后骨质疏松_专利_临床

概要

基本信息

药物类型

生物类似药、单克隆抗体

别名

靶点

RANKL

作用机制

RANKL抑制剂(肿瘤坏死因子配体超家族成员11抑制剂)

治疗领域

内分泌与代谢疾病皮肤和肌肉骨骼疾病

在研适应症

绝经期后骨质疏松

非在研适应症-

原研机构

Alkem Laboratories Ltd.

在研机构

Enzene Biosciences Ltd.

Alkem Laboratories Ltd.

非在研机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 143522H

当前序列信息引自: *****

Sequence Code 94568L

当前序列信息引自: *****

关联

3

项与地舒单抗生物类似药 (Alkem Laboratories) 相关的临床试验

NCT05405725 / Recruiting临床3期

A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women With Osteoporosis

This is a phase 3 Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women with Osteoporosis

开始日期2022-07-04

申办/合作机构

Enzene Biosciences Ltd.

[+1]

NCT05245669 / Recruiting临床1期

A Randomized, Double-blind, Three-arm, Parallel-group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (ENZ215, EU-sourced Prolia®, and US-sourced Prolia®) in Healthy Adult Male Volunteers

This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male volunteers.

开始日期2022-02-07

申办/合作机构

Enzene Biosciences Ltd.

[+1]

CTRI/2018/07/014908 / Completed临床3期

A Prospective, Active-controlled, Randomized, Double blind, Multicenter, Phase III Study to Compare the Safety and Efficacy of Biosimilar Denosumab of Enzene Biosciences Limited versus Innovator Denosumab in the Treatment of Postmenopausal Osteoporosis

开始日期2018-10-11

申办/合作机构

Alkem Laboratories Ltd.

[+1]

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