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 primary endpoint for both Phase 3 studies will be the six-minute walk distance (6MWD). The FDA does not require a cardiovascular outcomes trial for this indication. TNX-103 has the potential to address the underlying pathophysiology of PH-HFpEF and could provide a new approach for reducing high central and venous blood pressures associated with the condition.