VasThera (CEO Sangwon Kang, Professor, Department of Life Sciences, Ewha Womans University) today announced that the U.S. FDA has granted 

Orphan Drug Designation (ODD) to VTB-10, a candidate for the treatment of pulmonary arterial hypertension (PAH).

The company specializes in developing first-in-class drugs based on bactericide small molecules.

The FDA's orphan drug designation program supports the aggressive development and expedited approval of drugs for rare and difficult diseases 

with fewer than 200,000 patients. 

The orphan drug designation provides benefits such as tax credits for clinical expenses, exemption from new drug application review fees, 

and market exclusivity for seven years after approval of the new drug.

“Our drug for pulmonary arterial hypertension has shown excellent efficacy in animal models and safety in toxicity tests.” 

said Sangwon Kang, CEO of VasThera. ”Based on these preclinical results, we plan to start clinical trials in the first half of 2025."

“We will secure business development capabilities for future domestic and international clinical trials and technology export

to global pharmaceutical companies, and focus our resources on an IPO in the first half of 2026.” said Mr. Kang.

Founded in 2018, VasThera has a proprietary platform, Redoxizyme™, developing new drugs to treat pulmonary arterial hypertension, 

triple-negative breast cancer, and Alzheimer's disease, based on patented modulators of redox signaling. 

Based on the results of recently completed preclinical studies, the company plans to submit an IND to the Korean Ministry of Food and Drug Safety

in the first half of 2025 for the development of a treatment for pulmonary arterial hypertension and to initiate clinical trials. 

VasThera's pulmonary arterial hypertension treatment was selected by the Korea Drug Development Foundation (KDDF) 

as the winner of the 1st Outstanding New Drug Development Support Program for Promoting Global Access and Partnering, 

recognizing its potential as an innovative global drug. 

With this ODD approval, VasThera plans to accelerate its global clinical development and commercialization strategy for VTB-10, increasing its potential to enter the global market.

* News Link: [약업신문]바스테라, 폐동맥 고혈압 신약후보 물질 FDA 희귀의약품지정 획득