Delving into the Latest Updates on DTRMWXHS-12 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

DTRM-12, DTRMWXHS 12, DTRMWXHS12

Target

BTK

Action

inhibitors

Mechanism

BTK inhibitors(Tyrosine-protein kinase BTK inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [2]

Active Indication

Mantle-Cell LymphomaWaldenstrom Macroglobulinemia

Inactive Indication

Chronic Lymphocytic LeukemiaDiffuse Large B-Cell LymphomaFollicular Lymphoma+ [2]

Originator Organization

Zhejiang DTRM Biopharma Co. Ltd.

Active Organization

Zhejiang DTRM Biopharma Co. Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationSpecial Review Project (China)

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The Primary Objective is to evaluate the safety and tolerability of the DTRMWXHS-12 capsule in patients with relapsed/refractory MCL and recommend the dose and dosing method (RP2D) used in phase II study.
The Secondary Objective is to evaluate the pharmacokinetics (PK) of multiple dose oral administration of DTRMWXHS-12 capsule in patients with relapsed/refractory MCL.
The Exploratory Objective is to preliminarily evaluate the efficacy of DTRMWXHS-12 capsule in patients with relapsed/refractory MCL.

Start Date11 Jan 2019

Sponsor / Collaborator

Zhejiang DTRM Biopharma Co. Ltd.

NCT02891590

/ CompletedPhase 1

Phase Ia Study of the Safety, Tolerability and PK of BTK Inhibitor DTRMWXHS-12 in Patients With B-Cell Lymphoma

The Primary Objective is to evaluate the safety and tolerability of multiple dose oral administration of DTRMWXHS-12 capsule in patients with B-cell lymphoma.
The Secondary Objective is to evaluate the pharmacokinetics of multiple dose oral administration of DTRMWXHS-12 capsule in patients with B-cell lymphoma.

Start Date01 Sep 2016

Sponsor / Collaborator

Zhejiang DTRM Biopharma Co. Ltd.

100 Clinical Results associated with DTRMWXHS-12

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100 Translational Medicine associated with DTRMWXHS-12

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100 Patents (Medical) associated with DTRMWXHS-12

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100 Deals associated with DTRMWXHS-12

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Lymphocytic Leukemia	Phase 2	United States	Zhejiang DTRM Biopharma Co. Ltd.	24 Apr 2020
Diffuse Large B-Cell Lymphoma	Phase 2	United States	Zhejiang DTRM Biopharma Co. Ltd.	24 Apr 2020
Follicular Lymphoma	Phase 2	United States	Zhejiang DTRM Biopharma Co. Ltd.	24 Apr 2020
Mantle-Cell Lymphoma	Phase 2	China	Zhejiang DTRM Biopharma Co. Ltd.	-
Waldenstrom Macroglobulinemia	Phase 2	China	Zhejiang DTRM Biopharma Co. Ltd.	-
Mantle cell lymphoma recurrent	Phase 1	China	Zhejiang DTRM Biopharma Co. Ltd.	11 Jan 2019
Marginal Zone B-Cell Lymphoma	Phase 1	United States	Zhejiang DTRM Biopharma Co. Ltd.	01 Sep 2016