VASTHERA Receives U.S. FDA Clearance to initiate Phase 1 Clinical Trial of Pulmonary Arterial Hypertension Drug Candidate, VTB-10

On August 6, 2025, VASTHERA Co., Ltd. announced that it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for VTB-10, its drug candidate for pulmonary arterial hypertension (PAH), a rare, life-threatening disease marked by elevated blood pressure in the lung arteries.

VTB-10 is a first-in-class drug candidate developed using VASTHERA’s proprietary Redoxizyme™ platform. VASTHERA identified a deficiency of the enzyme peroxiredoxin (PRX) in PAH lesions and developed VTB-10, a small molecule enzyme (Chemzyme) that precisely replicates PRX function. In preclinical studies, VTB-10 reversed abnormal vascular remodeling and restored functional endothelium. These dual effects clearly differentiate it from existing therapies.

This milestone follows the FDA’s designation of VTB-10 as an Orphan Drug (ODD) in November 2024, enabling VASTHERA to formally begin global clinical development. The program has been supported by national funding from the Korea Drug Development Fund (KDDF).

Dr. Sang Wong Kang, Ph.D., CEO of VASTHERA, stated, “The U.S. clinical entry of VTB-10 marks a major milestone, demonstrating VASTHERA’s technological competitiveness in PAH treatment and reinforcing the global credibility of Korean biotech ventures. Through upcoming clinical trials, we aim to deliver an innovative treatment that can significantly improve quality of life for PAH patients.”

Dr. Sang Wong Kang is an expert in redox regulation of cellular signaling since his early research at the NIH/NHLBI, has dedicated more than two decades to building the scientific foundation of the Redoxizyme™ platform. Since PRX deficiency is implicated in multiple diseases, this platform holds broad potential for developing novel therapeutics across various indications, supporting sustainable growth and long-term value creation in the global market. VASTHERA is building up its Redoxizyme™-based pipeline with VTB-10 as the cornerstone, and the initiation of the Phase 1 clinical study will mark a significant step in the evolution of its VASTHERA’s pipeline portfolio with global potential.

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