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

Sponsor
NS Pharma, Inc.
Study ID
NCT07441200
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • NS-863 Low Dose — DRUG
    NS-863 is an orally administered drug
  • NS-863 High Dose — DRUG
    NS-863 is an orally administered drug
  • NS-863 Placebo — DRUG
    An orally administered NS-863 matching placebo

Study Details

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)

Key Dates

First listed
Feb 27, 2026
Start date
Jul 1, 2026
Status verified
Jan 2026
Primary completion
Aug 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: NS-863 Low Dose
    NS-863 is an orally administered drug
  • Active Comparator: NS-863 High Dose
    NS-863 is an orally administered drug
  • Placebo Comparator: NS-863 Placebo
    An orally administered NS-863 matching placebo

Primary Outcome Measure

Change in pulmonary vascular resistance (PVR) at week 24 [ Time Frame: From baseline to week 24 ]

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