Delving into the Latest Updates on Birociclib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

吡洛西利, XZP 3287, XZP-3287

+ [1]

Target

CDK4 x CDK6

Action

inhibitors

Mechanism

CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesUrogenital Diseases

Active Indication

Hormone receptor positive HER2 negative breast cancerAdvanced breast cancerAdvanced Malignant Solid Neoplasm+ [1]

Inactive Indication-

Originator Organization

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

Active Organization

Jilin Sihuan Pharmaceutical Co. Ltd.

Xuanzhu Biopharmaceutical Co., Ltd.Startup

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

+ [1]

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

Login to view timeline

考察[14C]吡罗西尼在健康受试者全血和血浆的分配情况以及全血和血浆中总放射性的药代动力学特征；定量分析健康受试者单次口服[14C]吡罗西尼后排泄物的总放射性，获得人体内物质平衡数据及主要排泄途径；评估健康受试者单次口服[14C]吡罗西尼的安全性。

[Translation]

To investigate the distribution of [14C]birocin in whole blood and plasma of healthy subjects and the pharmacokinetic characteristics of total radioactivity in whole blood and plasma; Quantitatively analyze the total radioactivity excreted in healthy subjects after a single oral administration of [14C]birocin to obtain material balance data and main excretion pathways in the human body; Evaluate the safety of a single oral administration of [14C]birocin to healthy subjects.

Start Date10 Nov 2022

Sponsor / Collaborator

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

[+1]

NCT05478109

/ Unknown statusPhase 1

the Material Balance and Biotransformation Study of [14C] XZP-3287 in Healthy Chinese Male Subjects

A single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] XZP-3287

Start Date02 Aug 2022

Sponsor / Collaborator

Xuanzhu Biopharmaceutical Co., Ltd.Startup

CTR20220212

/ Active, not recruitingPhase 3

吡罗西尼片（XZP-3287）联合来曲唑/阿那曲唑对比安慰剂联合来曲唑/阿那曲唑治疗HR阳性、HER2阴性晚期乳腺癌的多中心、随机、对照、双盲、III期临床研究

[Translation] A multicenter, randomized, controlled, double-blind, phase III clinical study of piroximate tablets (XZP-3287) combined with letrozole/anastrozole versus placebo combined with letrozole/anastrozole in the treatment of HR-positive, HER2-negative advanced breast cancer

主要目的：比较吡罗西尼片联合来曲唑/阿那曲唑与安慰剂联合来曲唑/阿那曲唑治疗HR阳性、HER2阴性的局部晚期、复发或转移性乳腺癌受试者的有效性。次要目的：比较吡罗西尼片联合来曲唑/阿那曲唑与安慰剂联合来曲唑/阿那曲唑治疗HR阳性、HER2阴性的局部晚期、复发或转移性乳腺癌受试者的有效性、安全性以及群体药代动力学特征。探索性目的：评估吡罗西尼片联合来曲唑/阿那曲唑对比安慰剂联合来曲唑/阿那曲唑治疗后受试者疾病或治疗相关症状的患者报告结果（PRO），包括生活质量评分和健康状态评分。

[Translation]

Primary objective: To compare the efficacy of pirocitabine tablets combined with letrozole/anastrozole and placebo combined with letrozole/anastrozole in the treatment of subjects with HR-positive, HER2-negative locally advanced, recurrent or metastatic breast cancer. Secondary objective: To compare the efficacy, safety and population pharmacokinetic characteristics of pirocitabine tablets combined with letrozole/anastrozole and placebo combined with letrozole/anastrozole in the treatment of subjects with HR-positive, HER2-negative locally advanced, recurrent or metastatic breast cancer. Exploratory objective: To evaluate patient-reported outcomes (PROs) of disease- or treatment-related symptoms in subjects treated with pirocitabine tablets combined with letrozole/anastrozole versus placebo combined with letrozole/anastrozole, including quality of life scores and health status scores.

Start Date14 Mar 2022

Sponsor / Collaborator

Xuanzhu Biopharmaceutical Co., Ltd.Startup

100 Clinical Results associated with Birociclib

Login to view more data

100 Translational Medicine associated with Birociclib

Login to view more data

100 Patents (Medical) associated with Birociclib

Login to view more data

100 Deals associated with Birociclib

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hormone receptor positive HER2 negative breast cancer	NDA/BLA	China	Asymchem Life Science Tianjin Co. Ltd.	30 Aug 2023
Advanced breast cancer	Phase 3	China	Xuanzhu Biopharmaceutical Co., Ltd.Startup	16 Nov 2021
Advanced Malignant Solid Neoplasm	Phase 1	China	Jilin Sihuan Pharmaceutical Co. Ltd.	27 Apr 2018
Advanced Malignant Solid Neoplasm	Phase 1	China	Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.	27 Apr 2018
Prostatic Cancer	IND Approval	China	Xuanzhu Biopharmaceutical Co., Ltd.Startup	28 Jun 2023