Trial intelligence / Profile preview

NS-863 in Pulmonary Hypertension Associated With Interstitial Lung Disease

NCT07441278Phase 2

Key facts

Status: Recruiting
Start: Sep 2026
Primary completion: Sep 2028
Countries: 2
Sponsor: NS Pharma, Inc.
Modality: Small Molecules

Drugs: NS-863
Conditions: Pulmonary Hypertension Due To Interstitial Lung Disease (PH-ILD)

Overview

Phase 2, randomised, double-blind trial of NS-863 in Pulmonary Hypertension Due To Interstitial Lung Disease (PH-ILD) (3 arms), sponsored by NS Pharma, Inc. Primary endpoints: Pulmonary Vascular Resistance at 24 weeks and Adverse Events at 24 weeks. Started Sep 2026; status: recruiting.

Design

3 arms

Study design: RandomizedDouble-blind

NS-863 Low Dose
NS-863 Low Dose orally administered
NS-863 High Dose
NS-863 High Dose orally administered
Placebo
Placebo orally administered

Who it enrols

Adults aged 18-80 with WHO Group 3 PH-ILD confirmed by HRCT and RHC, with stable background therapy. Excludes patients with significant left-sided heart disease (LVEF <40%), severe hepatic or renal impairment, recent acute pulmonary embolism, or active infections.

Endpoints

Primary

Pulmonary Vascular Resistance24 weeks
Adverse Events24 weeks

Secondary

Hemodynamic parameters24 weeks
6-Minute Walk Distance24 weeks
Borg dyspnea scale24 weeks
World Health Organization Functional Classification24 weeks
Echocardiogram24 weeks
The King's Brief Interstitial Lung Disease24 weeks

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