Delving into the Latest Updates on Birociclib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

吡洛西利

+ [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.

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

+ [1]

Inactive Organization-

License Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationSpecial Review Project (China)

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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.

NCT05257395

/ Active, not recruitingPhase 3

A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 Combined With Letrozole/Anastrozole Versus Placebo Combined With Letrozole/Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer

This is a Phase III clinical trial designed to evaluate the efficacy and safety of XZP-3287 in combination with Letrozole/Anastrozole versus placebo in combination with Letrozole/Anastrozole in patients with HR-positive and HER2-negative recurrent/metastatic breast cancer who have not received systemic anticancer therapy.

Start Date14 Mar 2022

Sponsor / Collaborator

Xuanzhu Biopharmaceutical Co., Ltd.

100 Clinical Results associated with Birociclib

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100 Translational Medicine associated with Birociclib

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100 Patents (Medical) associated with Birociclib

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100 Deals associated with Birociclib

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R&D Status

10 top R&D records.

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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.	16 Nov 2021
Advanced Malignant Solid Neoplasm	Phase 1	China	Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.	27 Apr 2018
Advanced Malignant Solid Neoplasm	Phase 1	China	Jilin Sihuan Pharmaceutical Co. Ltd.	27 Apr 2018
Prostatic Cancer	IND Approval	China	Xuanzhu Biopharmaceutical Co., Ltd.	28 Jun 2023