VASTHERA Receives FDA Clearance on Pulmonary Arterial Hypertension Candidate VTB-10
Wednesday, August 20, 2025
VASTHERA has received clearance from the US Food and Drug Administration (FDA) to begin a Phase 1 clinical trial of VTB-10, its investigational therapy for pulmonary arterial hypertension (PAH).
VTB-10 is the first drug candidate developed through VASTHERA’s Redoxizyme™ platform. The company discovered that PAH lesions show a lack of the enzyme peroxiredoxin (PRX) and created VTB-10, a small-molecule enzyme designed to mimic PRX activity.
Preclinical studies showed that VTB-10 reversed abnormal blood vessel changes and helped restore normal endothelial function, setting it apart from current treatment options.
PAH is a rare and serious condition caused by high blood pressure in the lung arteries.
The FDA had previously granted VTB-10 Orphan Drug Designation in November 2024, and the Phase 1 clearance enables the formal start of its global clinical development.
The project has also received support from the Korea Drug Development Fund (KDDF).
Source: businesswire.com
