Delving into the Latest Updates on Tibremciclib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

康美纳, 酒石酸泰贝西利, BPI 16350

+ [1]

Target

CDK4 x CDK6

Mechanism

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

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Hormone receptor positive HER2 negative breast cancerAdvanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Betta Pharmaceuticals Co., Ltd.

Active Organization

Betta Pharmaceuticals Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationSpecial Review Project (CN)

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Structure

Molecular FormulaC28H32F2N8

InChIKeyXOJPAVACYRFOBK-GOSISDBHSA-N

CAS Registry2397678-18-9

This is a phase III clinical trial to evaluate the efficacy and safety of BPI-16350 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative locally advanced，recurrent or metastatic breast cancer with disease progression following endocrine therapy.

Start Date25 May 2022

Sponsor / Collaborator

Betta Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Tibremciclib

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100 Translational Medicine associated with Tibremciclib

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100 Patents (Medical) associated with Tibremciclib

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100 Deals associated with Tibremciclib

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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	Phase 3	CN	Betta Pharmaceuticals Co., Ltd.	25 May 2022
Advanced Malignant Solid Neoplasm	Phase 1	CN	Betta Pharmaceuticals Co., Ltd.	17 Jul 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05433480 (ESMO2024) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| Hormone Receptor Positive	274	Tibremciclib 400 mg+fulvestrant	ftdtbpxxgz(wfsqocsggs) = ozjkuiezrb ihcnbxeasq (ehilwwuwau, 9.23 - 12.85) View more	Positive	16 Sep 2024
				Placebo+fulvestrant	ftdtbpxxgz(wfsqocsggs) = sjkxfvbrzc ihcnbxeasq (ehilwwuwau, 4.21 - 7.36) View more
NCT03791112 (ASCO2023) Manual	Phase 1	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| HR Positive	70	BPI-16350	bjtupacdte(doocsvcsic) = vspciqwfyx arjlezkpgy (obrabhfmoh ) View more	Positive	31 May 2023
				Fulvestrant+BPI-16350	bjtupacdte(doocsvcsic) = qjmrijktjp arjlezkpgy (obrabhfmoh ) View more