Tenax Therapeutics Receives FDA Clearance for Phase 3 Trial of TNX-103 for PH-HFpEF

Tenax Therapeutics has received FDA clearance for its Investigational New Drug (IND) application for TNX-103, an oral levosimendan, for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). The company plans to initiate the first of two Phase 3 studies, called the LEVEL Study, in the fourth quarter of 2023. The Phase 3 program aims to enroll 300 patients for 6 months and 100 patients for 1 year, with the primary endpoint being the 6-minute walk distance. The FDA does not require a cardiovascular outcomes trial, and the use of oral levosimendan in PH-HFpEF is protected by a patent until 2040. PH-HFpEF currently has no FDA-approved treatments, and the prevalence is estimated to exceed 2 million patients in North America by 2030.