Tenax Therapeutics' LEVEL-2 Phase 3 trial of oral levosimendan in PH-HFpEF is active, not recruiting

The week's only update concerns Tenax Therapeutics' ongoing late-stage heart failure trial.

• LEVEL-2 is a Phase 3, double-blind, randomized, placebo-controlled study of levosimendan in pulmonary hypertension patients with heart failure with preserved left ventricular ejection fraction, testing the drug given orally against placebo and measuring change in 6-Minute Walk Distance¹. The study's status is listed as active, not recruiting, with an actual start date of 2026-03-03 and an estimated primary completion date of 2028-06-30. The trial plans to enroll approximately 540 participants randomized in a 2:1 ratio to receive an oral dose of levosimendan or placebo¹, with the primary outcome measured as change in 6-minute walk distance¹.