Tenax Therapeutics reported additional Phase 3 trial results for its investigational drug TNX-103 (levosimendan) in pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) at the European Society of Cardiology Congress 2026 in Munich.
The LEVEL trial, which enrolled 241 patients across 41 sites in the United States and Canada, failed to meet its primary endpoint of change in 6-minute walk distance at Week 12. A key secondary endpoint assessing symptom scores also did not achieve statistical significance. However, TNX-103 demonstrated a favorable safety profile with no significant arrhythmias reported.
In a predefined subgroup of patients with a baseline 6-minute walk distance below the trial median of 333 meters, TNX-103 showed clinically meaningful improvements. The treatment resulted in a 26.3-meter improvement in 6-minute walk distance compared to placebo (p = 0.0112), a 47% reduction in NT-proBNP levels (p < 0.0001), and a 4.9 mmHg reduction in right ventricular systolic pressure (p = 0.009).
Tenax plans to use these findings to enrich the population in the ongoing LEVEL-2 trial, focusing on patients with more severe baseline impairment. The company remains committed to advancing the global development of TNX-103. Levosimendan, the active ingredient in TNX-103, is currently authorized for intravenous use in 60 countries for acutely decompensated heart failure but is not available in the United States or Canada.
