Delving into the Latest Updates on THDBH-130 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

THDBH 130, THDBH-130, THDBH130

Target

URAT1

Action

inhibitors

Mechanism

URAT1 inhibitors(Uric acid transporter 1 inhibitors)

Therapeutic Areas

Urogenital Diseases

Active Indication

Renal Insufficiency

Inactive Indication

Hyperuricemia

Originator Organization

Nanjing Mingde New Drug Research and Development Co., Ltd.

Active Organization

Tonghua Dongbao Pharmaceutical Co., Ltd.Nanjing Mingde New Drug Research and Development Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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To compare the pharmacokinetic (PK) characteristics of a single oral dose of THDBH130 in subjects with normal renal function, mild renal impairment, and moderate renal impairment; to evaluate the safety and tolerability of oral THDBH130 in subjects with normal renal function, mild renal impairment, and moderate renal impairment.

Start Date27 Jul 2023

Sponsor / Collaborator

Tonghua Dongbao Pharmaceutical Co., Ltd.

[+1]

CTR20222979

/ CompletedPhase 2

一项在成人高尿酸血症伴或不伴痛风患者中评价THDBH130片的安全性、耐受性、初步临床有效性及药代/药效动力学特征的多中心、随机、双盲、安慰剂和苯溴马隆对照 IIa期临床研究

[Translation] A multicenter, randomized, double-blind, placebo- and benzbromarone-controlled Phase IIa clinical study to evaluate the safety, tolerability, preliminary clinical efficacy, and pharmacokinetic/pharmacodynamic characteristics of THDBH130 tablets in adult patients with hyperuricemia with or without gout

1、评估成人高尿酸血症伴或不伴痛风患者口服 THDBH130 片的安全性和耐受性 2、评估成人高尿酸血症伴或不伴痛风患者口服 THDBH130片的初步有效性

[Translation]

1. To evaluate the safety and tolerability of oral THDBH130 tablets in adult patients with hyperuricemia with or without gout 2. To evaluate the preliminary effectiveness of oral THDBH130 tablets in adult patients with hyperuricemia with or without gout

Start Date13 Jan 2023

Sponsor / Collaborator

Tonghua Dongbao Pharmaceutical Co., Ltd.

[+1]

CTR20220675

/ CompletedPhase 1

THDBH130片在健康成人受试者中单次和多次给药的安全性、耐受性、药代/药效动力学及食物影响的 I 期临床研究

[Translation] Phase I clinical study of the safety, tolerability, pharmacokinetics/pharmacodynamics and food effects of single and multiple doses of THDBH130 tablets in healthy adult subjects

主要目的：评估健康成人空腹条件下单次口服 THDBH130 的安全性和耐受性，评估健康成人多次口服 THDBH130 的安全性和耐受性次要目的：评估健康成人空腹条件下单次和多次口服THDBH130的药代/药效动力学（PK/PD 特征）

[Translation]

Primary objective: To evaluate the safety and tolerability of a single oral dose of THDBH130 in healthy adults under fasting conditions, and to evaluate the safety and tolerability of multiple oral doses of THDBH130 in healthy adults Secondary objective: To evaluate the pharmacokinetics/pharmacodynamics (PK/PD characteristics) of single and multiple oral doses of THDBH130 in healthy adults under fasting conditions

Start Date18 Apr 2022

Sponsor / Collaborator

Tonghua Dongbao Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with THDBH-130

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100 Translational Medicine associated with THDBH-130

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100 Patents (Medical) associated with THDBH-130

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100 Deals associated with THDBH-130

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperuricemia	Phase 2	China	Nanjing Mingde New Drug Research and Development Co., Ltd.	13 Jan 2023
Hyperuricemia	Phase 2	China	Tonghua Dongbao Pharmaceutical Co., Ltd.	13 Jan 2023
Renal Insufficiency	Phase 1	China	Nanjing Mingde New Drug Research and Development Co., Ltd.	27 Jul 2023
Renal Insufficiency	Phase 1	China	Tonghua Dongbao Pharmaceutical Co., Ltd.	27 Jul 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20222979 (NEWS)	Phase 2	Hyperuricemia	-	THDBH130	nyzplndtan(osemktvjbt) = 可剂量依赖性地降低痛风患者的血尿酸水平 mmhwvewvkh (vmswnhuyvh )	Positive	16 Jan 2024
				安慰剂