Delving into the Latest Updates on TGRX-678 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

Bcr-Abl x Bcr-Abl T315I

Action

inhibitors

Mechanism

Bcr-Abl T315I inhibitors(BCR-ABL T315I mutation inhibitors), Bcr-Abl inhibitors(Bcr-Abl tyrosine kinase inhibitors)

Therapeutic Areas

NeoplasmsHemic and Lymphatic Diseases

Active Indication

Aggressive-Phase Chronic Myelocytic LeukemiaPhiladelphia chromosome positive chronic myelogenous leukemiarefractory chronic myelocytic leukemia

Inactive Indication-

Originator Organization

Shenzhen TargetRx, Inc.

Active Organization

Shenzhen TargetRx, Inc.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationBreakthrough Therapy (China)

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主要研究目的：评价健康受试者在空腹、进食低脂餐和进食高脂餐状态下，单次口服TGRX-678片后TGRX-678的药代动力学特征以及食物对TGRX-678药代动力学的影响。次要研究目的：评价健康受试者在空腹、进食低脂餐和进食高脂餐状态下，单次口服TGRX-678片的安全性和耐受性。

[Translation]

Primary study objective: To evaluate the pharmacokinetic characteristics of TGRX-678 after a single oral administration of TGRX-678 tablets in healthy subjects in the fasting, low-fat meal and high-fat meal states, as well as the effect of food on the pharmacokinetics of TGRX-678. Secondary study objective: To evaluate the safety and tolerability of a single oral administration of TGRX-678 tablets in healthy subjects in the fasting, low-fat meal and high-fat meal states.

Start Date21 Nov 2024

Sponsor / Collaborator

Shenzhen TargetRx, Inc.

NCT06453902

/ RecruitingPhase 2

A Single-arm, Open-label, Multi-center Phase II Study Evaluating Efficacy and Safety of TGRX-678 in CML-AP Patients Relapsed or Refractory from 3rd-generation TKI Treatment

A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment

Start Date15 Jul 2024

Sponsor / Collaborator

Shenzhen TargetRx, Inc.

[+8]

100 Clinical Results associated with TGRX-678

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100 Translational Medicine associated with TGRX-678

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100 Patents (Medical) associated with TGRX-678

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100 Deals associated with TGRX-678

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Aggressive-Phase Chronic Myelocytic Leukemia	Phase 2	China	Shenzhen TargetRx, Inc.	04 Jul 2024
Philadelphia chromosome positive chronic myelogenous leukemia	Phase 1	China	Shenzhen TargetRx, Inc.	07 Apr 2021
refractory chronic myelocytic leukemia	Phase 1	China	Shenzhen TargetRx, Inc.	29 Mar 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024	Not Applicable	Chronic Myelogenous Leukemia	-	TGRX-678	(nesqznicvf) = hlueripiar ebuninfyrk (fmkiczjapa ) View more	-	08 Dec 2024
ASH2023	Phase 1	refractory chronic myelocytic leukemia	95	TGRX-678	(brxtiocgty) = ceswcojpof nojzhvhmvi (kfdreccbml ) View more	-	11 Dec 2023