NS-863 / Nippon Shinyaku - LARVOL DELTA

Late Breaking Abstract - Efficacy of NS-863, a novel orally bioavailable selective PDGFR inhibitor, in preclinical rat models of PAH and PH-ILD (ERS 2026) - "NS-863 potently and selectively inhibits PDGFR signaling and demonstrates marked improvements in pulmonary vascular and RV remodeling in preclinical rat models of PAH and PH‑ILD, with less myelosuppressive effects. Favorable PK and tolerability were observed in Phase 1, and efficacious plasma concentrations from these in vivo models are expected to be achievable in Phase 2."

Late-breaking abstract • Preclinical • Cardiovascular • Interstitial Lung Disease • Pulmonary Arterial Hypertension

Phase 1 safety, tolerability, and pharmacokinetics of NS-863 supporting development for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease (ESC 2026) - "NS‑863 demonstrated a favourable safety and tolerability profile up to a 232 mg single dose and 116 mg BID for 7 days, with linear and predictable PK across races, sex and food conditions. These results support the initiation of global Phase 2 studies evaluating the efficacy and safety of NS‑863 in PAH and PH‑ILD, planned to begin in 2026."

Clinical • First-in-human • P1 data • PK/PD data • Cardiovascular

Clinical Trial of NS-863 in Participants With Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) - P2 | N=135 | Not yet recruiting | Sponsor: NS Pharma, Inc.

New P2 trial • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Clinical Trial of NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) (clinicaltrials.gov) - P2 | N=177 | Not yet recruiting | Sponsor: NS Pharma, Inc.

New P2 trial • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases