Tenax Therapeutics, Chapel Hill, North Carolina, August 29, 2026
Tenax Therapeutics announced the presentation of additional Phase 3 LEVEL clinical trial results for TNX-103 (oral levosimendan) during a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany. The company said the new analyses provide additional insight into the treatment effect of TNX-103 in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF). The findings further define the patient population most likely to benefit from treatment and are expected to guide the design and population strategy for the company’s next Phase 3 development program, LEVEL-2. Tenax emphasized that the analyses reinforce the biological activity of TNX-103 across measures associated with cardiac stress and pulmonary pressure, supporting continued development of levosimendan for a patient population with significant unmet medical need.
LEVEL Results Help Define Target Patient Population
The LEVEL Phase 3 trial randomized 241 patients across 41 sites in the United States and Canada, evaluating TNX-103 in patients with PH-HFpEF. While the overall study did not meet statistical significance on its primary endpoint of change in 6-minute walk distance (6MWD) at Week 12, the additional analyses presented at ESC Congress identified a treatment effect concentrated among patients with lower baseline exercise capacity. In patients whose baseline 6MWD was below the trial median of 333 meters, TNX-103 produced a 26.3-meter placebo-adjusted improvement in walking distance. Tenax said the analysis provides important clinical-development insight because the treatment effect increased as baseline exercise capacity decreased. The company intends to use these findings to enrich the LEVEL-2 study population, focusing future development on patients in whom a treatment effect was most clearly demonstrated in LEVEL.
TNX-103 Shows Biological Effects Across Key Measures
Additional findings from LEVEL highlighted the biological effects of TNX-103 on cardiovascular parameters. In the subgroup with baseline 6MWD below 333 meters, TNX-103 was associated with a 47% reduction in NT-proBNP compared with placebo, alongside a 4.9 mmHg reduction in right ventricular systolic pressure (RVSP). NT-proBNP is an established biomarker associated with cardiac wall stress, while RVSP provides information about pulmonary pressure. Tenax also reported improvements across multiple echocardiographic measures, with approximately 20 echocardiographic parameters showing improvement across different domains. The company said these findings add to earlier evidence from the Phase 2 HELP study and support the potential of levosimendan to address physiological abnormalities associated with PH-HFpEF. TNX-103 was reported to be safe and well tolerated across the overall LEVEL population, with no significant arrhythmia signal identified in the trial.
Advertisement
Tenax Advances Next Phase of Levosimendan Development
Following completion of the full statistical analysis, Tenax Therapeutics said the LEVEL findings will inform the design and population enrichment strategy for LEVEL-2, its next Phase 3 study of oral levosimendan in PH-HFpEF. The company believes the results provide a clearer development strategy by identifying patients with lower baseline exercise capacity as a population in which the treatment effect was more pronounced. TNX-103 is an oral formulation of levosimendan, a cardiac therapy that acts through calcium sensitization and potassium-channel activation. Levosimendan has previously received market authorization in numerous countries for intravenous treatment of acute decompensated heart failure, although it is not approved in the United States or Canada for that indication. Tenax is developing oral levosimendan specifically for PH-HFpEF, an area where no approved treatment currently exists. The company plans to use the latest LEVEL data to shape its registrational development pathway and advance TNX-103 toward the next stage of clinical evaluation.
Source:Cytokinetics,press relese
