Delving into the Latest Updates on NS-041 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

NS 041

Target

Kv7.2 x Kv7.3

Mechanism

Kv7.2 agonists(Voltage-gated potassium channel subunit Kv7.2 agonists), Kv7.3 stimulants(Potassium voltage-gated channel subfamily KQT member 3 stimulants)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

EpilepsyDepressive Disorder, MajorDepressive Disorder+ [1]

Inactive Indication-

Originator Organization

NeuShen Therapeutics (Shanghai) Co., Ltd.

Active Organization

NeuShen Therapeutics (Shanghai) Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Primary objective: To evaluate the safety and tolerability of single ascending dose (SAD) and multiple ascending dose (MAD) of NS-041 in healthy adults, and the pharmacokinetic characteristics of food effect (FE); Secondary objective: To evaluate the pharmacokinetic characteristics of SAD and MAD of NS-041 in healthy adults, and the safety and tolerability of FE.

Start Date19 Apr 2024

Sponsor / Collaborator

NeuShen Therapeutics (Shanghai) Co., Ltd.

CTR20244520 / Not yet recruitingPhase 1

评价在中国健康成年人中伊曲康唑对NS-041药代动力学特征影响

[Translation] Evaluation of the effect of itraconazole on the pharmacokinetic characteristics of NS-041 in healthy Chinese adults

1. 在中国健康成年人中评价口服CYP3A抑制剂伊曲康唑胶囊对口服NS-041的药代动力学（PK）特征的影响。 2. 评估单次口服NS-041及多次口服伊曲康唑胶囊的同时单次口服NS-041后的安全性和耐受性。

[Translation]

1. To evaluate the effect of itraconazole capsules, an oral CYP3A inhibitor, on the pharmacokinetic (PK) characteristics of oral NS-041 in healthy Chinese adults. 2. To evaluate the safety and tolerability of a single oral dose of NS-041 and a single oral dose of NS-041 combined with multiple oral doses of itraconazole capsules.

Start Date-

Sponsor / Collaborator

NeuShen Therapeutics (Shanghai) Co., Ltd.

100 Clinical Results associated with NS-041

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100 Translational Medicine associated with NS-041

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100 Patents (Medical) associated with NS-041

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100 Deals associated with NS-041

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Epilepsy	Phase 1	CN	NeuShen Therapeutics (Shanghai) Co., Ltd.	19 Apr 2024
Depressive Disorder, Major	Phase 1	-	NeuShen Therapeutics (Shanghai) Co., Ltd.	-
Depressive Disorder	Preclinical	CN	NeuShen Therapeutics (Shanghai) Co., Ltd.	19 Jul 2024
Schizophrenia	Preclinical	CN	NeuShen Therapeutics (Shanghai) Co., Ltd.	27 Sep 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20241102 (NEWS) Manual	Phase 1	Epilepsy	-	NS-041	dcnvqjxrsa(itfeoajnyl) = 该研究探索了5个剂量的单次给药和3个剂量的多次给药，结果展示出良好的安全性和药代动力学特征。项目组目前在进行统计分析和报告撰写，并积极为II期临床试验做准备。 thzinckmqv (ayovkedyms )	Positive	14 Nov 2024