Delving into the Latest Updates on NH-130 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

NH130枸橼酸盐, NH 130, NH-130

+ [1]

Target

5-HT2A receptor

Action

inverse agonists

Mechanism

5-HT2A receptor inverse agonists(Serotonin 2a (5-HT2a) receptor inverse agonists)

Therapeutic Areas

Nervous System DiseasesEndocrinology and Metabolic Disease

Active Indication

Parkinson DiseasePsychotic DisordersAlzheimer Disease+ [1]

Inactive Indication-

Originator Organization

Jiangsu Nhwa Pharmaceutical Co., Ltd.

Active Organization

Jiangsu Nhwa Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Primary objective: To evaluate the efficacy of NH130 for the treatment of psychotic symptoms in Parkinson's disease (PD) compared with placebo. Secondary objective: To evaluate the safety of NH130 in patients with Parkinson's disease (PD). Exploratory objective: To evaluate the population pharmacokinetic profile of NH130.

Start Date17 Nov 2025

Sponsor / Collaborator

Jiangsu Nhwa Pharmaceutical Co., Ltd.

CTR20240362

/ CompletedPhase 1

评价健康受试者多次口服NH130枸橼酸盐片的安全性、耐受性和药代动力学特征的随机、双盲、安慰剂对照、剂量递增的Ⅰ期临床研究

[Translation] A randomized, double-blind, placebo-controlled, dose-escalating phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of repeated oral administration of NH130 citrate tablets in healthy subjects

主要目的：评价健康受试者空腹多次口服NH130枸橼酸盐片的安全性和耐受性。次要目的：1.评价健康受试者空腹多次口服NH130枸橼酸盐片的药代动力学（PK）特性。2.初步评价多次口服NH130枸橼酸盐片对受试者QTc间期的影响。

[Translation]

Primary objective: To evaluate the safety and tolerability of multiple oral administration of NH130 citrate tablets on an empty stomach in healthy subjects. Secondary objectives: 1. To evaluate the pharmacokinetic (PK) properties of multiple oral administration of NH130 citrate tablets on an empty stomach in healthy subjects. 2. To preliminarily evaluate the effect of multiple oral administration of NH130 citrate tablets on the QTc interval of subjects.

Start Date11 Mar 2024

Sponsor / Collaborator

Jiangsu Nhwa Pharmaceutical Co., Ltd.

CTR20230409

/ CompletedPhase 1

评价健康受试者单次口服NH130枸橼酸盐片的安全性、耐受性和药代动力学特征的随机、双盲、安慰剂对照、剂量递增的Ⅰ期临床研究

[Translation] A randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of a single oral dose of NH130 citrate tablets in healthy subjects

主要目的：评价健康受试者空腹单次口服NH130枸橼酸盐片的安全性和耐受性。次要目的： 1.评价健康受试者空腹单次口服NH130枸橼酸盐片的药代动力学（PK）特性。初步评价单次口服NH130枸橼酸盐片对受试者QTc间期的影响。

[Translation]

Primary objective: To evaluate the safety and tolerability of a single oral administration of NH130 citrate tablets on an empty stomach in healthy subjects. Secondary objectives: 1. To evaluate the pharmacokinetic (PK) properties of a single oral administration of NH130 citrate tablets on an empty stomach in healthy subjects. To preliminarily evaluate the effect of a single oral administration of NH130 citrate tablets on the QTc interval of subjects.

Start Date15 Mar 2023

Sponsor / Collaborator

Jiangsu Nhwa Pharmaceutical Co., Ltd.

100 Clinical Results associated with NH-130

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100 Translational Medicine associated with NH-130

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100 Patents (Medical) associated with NH-130

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1

Literatures (Medical) associated with NH-130

Frontiers in Pharmacology

Phase I clinical trial of NH130 and the prediction of its pharmacokinetics using physiologically based pharmacokinetic modeling

Article

Author: Zhang, Lan ; Du, Jialin ; Zhang, Kun ; Zhao, Shanshan

Background:

Parkinson’s disease psychosis (PDP) is a common and distressing complication of Parkinson’s disease (PD), characterized by hallucinations and delusions. This research aimed to assess the pharmacokinetics and safety of NH130, a selective serotonin 5-HT2A inverse agonist, as a potential PDP treatment in healthy individuals.

Methods:

We conducted clinical pharmacokinetic studies and safety evaluations for NH130, employing a physiologically based pharmacokinetic (PBPK) model to predict its behavior in human body.

Results:

In a single-dose escalation study, healthy volunteers received NH130 at varying doses (2 mg, 6 mg, 12 mg, 24 mg, 40 mg, 60 mg, and 90 mg) or a placebo. The drug demonstrated favorable pharmacokinetics, with no serious adverse events (AEs) reported. Clinical plasma concentrations correlated well with PBPK model predictions, validating the model’s utility for guiding future clinical development.

Conclusion:

NH130 showed promising pharmacokinetic characteristics and safety profile, supporting its progression to multi-dose trials and suggesting its potential as a therapeutic agent for PDP.

Clinical Trial Registration:

http://www.chinadrugtrials.org.cn/index.html, Identifier CTR20230409.

100 Deals associated with NH-130

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Parkinson Disease	Phase 2	China	Jiangsu Nhwa Pharmaceutical Co., Ltd.	17 Nov 2025
Psychotic Disorders	Phase 2	China	Jiangsu Nhwa Pharmaceutical Co., Ltd.	17 Nov 2025
Alzheimer Disease	IND Approval	China	Jiangsu Nhwa Pharmaceutical Co., Ltd.	17 Aug 2026
Schizophrenia	IND Approval	China	Jiangsu Nhwa Pharmaceutical Co., Ltd.	17 Aug 2026