Clinical Trial of NS-863 in Participants With Pulmonary Arterial Hypertension (PAH)

NCT07441200 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: NS-863A-P2-01
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Trial to Evaluate the Efficacy and Safety of Orally Administered NS-863 in Participants with Pulmonary Arterial Hypertension (PAH)

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

• Change in pulmonary vascular resistance (PVR) at week 24

  PVR is a hemodynamic variable of pulmonary circulation measured by right heart catheterization (RHC).

  From baseline to week 24

• Number of participants who experienced an adverse event (AE) up to approximately 24 weeks.

  An AE is any untoward medical occurrence in a study participant administered a study drug, which did not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug. whether or not it was considered related to the study drug.

  From baseline to week 24

Secondary Outcomes (6)

• Change in hemodynamic parameters at Week 24

  From baseline to week 24

• Change in 6-minute walk distance (6MWD) at weeks 12 and 24

  From baseline to weeks 12 and 24

• Change in Borg dyspnea scale at Week 12 and 24

  From baseline to weeks 12 and 24

• Change in Word Health Organization Functional Classification (WHO FC) at weeks 12 and 24

  From baseline to weeks 12 and 24

• Change in echocardiogram at weeks 12 and 24

  From baseline to weeks 12 and 24

Study Arms (3)

NS-863 Low Dose

ACTIVE COMPARATOR

NS-863 is an orally administered drug

Drug: NS-863 Low Dose

NS-863 High Dose

ACTIVE COMPARATOR

NS-863 is an orally administered drug

Drug: NS-863 High Dose

NS-863 Placebo

PLACEBO COMPARATOR

An orally administered NS-863 matching placebo

Drug: NS-863 Placebo

Interventions

NS-863 Low Dose DRUG

NS-863 is an orally administered drug

NS-863 Low Dose

NS-863 High Dose DRUG

NS-863 is an orally administered drug

NS-863 High Dose

NS-863 Placebo DRUG

An orally administered NS-863 matching placebo

NS-863 Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent prior to participation in the trial, which includes the ability to comply with the requirements and restrictions listed in the informed consent form (ICF). Participants must be able to read, comprehend, and write at a level sufficient to complete trial-related materials
• Adult male or female participants 18 to 75 years of age at the time the ICF is signed
• Diagnosed with Group 1 PAH and pre-capillary PH defined by RHC during or at any time prior to the Screening Visit in any of the following subtypes:
• Idiopathic PAH (IPAH)
• Heritable PAH (HPAH)
• PAH associated drug and toxins (DPAH)
• PAH associated with connective tissue disease (PAH-CTD)
• PAH associated with congenital heart disease (PAH-CHD); simple systemic to pulmonary shunt at least 6 months after surgical repair
• Diagnosed as WHO FC II, III, or IV on stable background therapy
• Results of the RHC within 35 days prior to Day 1 and meet all of the following criteria:
• Participants receiving treatment with endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, soluble guanylate cyclase stimulators, prostacyclin analogs or prostacyclin receptor agonists, calcium channel blocker, and/or diuretics are eligible only if on a stable dose for at least 90 days prior to RHC at baseline and throughout the Screening Period. For infusion prostacyclin analogs, dose adjustment based on the participant's body weight is allowed per medical practice. Stable diuretic therapy is defined as no addition of a new diuretic and no switching of a preexistent oral diuretic to parenteral administration; however, dose adjustments (up or down) in preexistent oral diuretics are acceptable
• Participants receiving treatment with activin-signaling inhibitor are eligible only if on a stable dose for at least 180 days prior to RHC at baseline and throughout the Screening Period. Dose adjustment based on the participant's body weight is allowed per medical practice.
• Valid 6-minute walk distance (6MWD)
• Women of childbearing potential (WOCBP) must have a negative pregnancy test before receiving the trial treatment and must agree to use contraception from the Screening Visit to at least 30 days after the last dose of the trial treatment. Male participants who could potentially cause pregnancy must agree to use contraception from the Screening Visit to at least 90 days after the last dose of the trial treatment to avoid pregnancy in their partners
• Able to complete the scheduled visits and follow the instructions of the investigator

You may not qualify if:

• Current diagnosis of the following PAH Group 1 subtypes:
• PAH associated with human immunodeficiency virus (HIV) infection
• PAH associated with portal hypertension
• PAH associated with schistosomiasis
• PAH with features of venous/capillary involvement
• Eisenmenger syndrome and PAH associated with prevalent systemic to pulmonary shunts in PAH-CHD
• Have ≥3 of the following LV disease/dysfunction risk factors. :
• Body mass index (BMI) ≥30 kg/m2 at the Screening Visit
• History of essential hypertension
• Diabetes mellitus (any type)
• Historical evidence of significant coronary artery disease
• Diagnosis of PH Groups 2, 3, 4, or 5 of the classification
• Moderate or severe obstructive lung disease (forced expiratory volume in one second \[FEV1\]/forced vital capacity \[FVC\] \<0.6) or restrictive lung disease (total lung capacity \[TLC\] \<70% of predicted value or lung diffusion capacity for carbon monoxide \[DLco\] \<45% except for PAH-systemic sclerosis) during the Screening Period.
• Moderate or severe liver, renal, blood, or psychiatric disease:
• Moderate and severe hepatic impairment by the Child-Pugh scoring system (Class B and Class C)

Sponsors & Collaborators

• NS Pharma, Inc.: lead
• Nippon Shinyaku Co., Ltd.: collaborator

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 27, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-01