Tenax Therapeutics has temporarily paused enrollment in its global Phase 3 LEVEL-2 clinical trial of oral levosimendan for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF). The pause allows the company to implement an amended protocol that enriches patient selection based on key learnings from the recently completed Phase 3 LEVEL trial. Specifically, the new criteria target patients with higher disease burden who are most likely to demonstrate improved exercise tolerance in the primary endpoint. Tenax has requested a Type C meeting with the U.S. Food and Drug Administration to discuss the overall development of levosimendan. The company remains funded through Q2 2028.
