CHAPEL HILL, N.C., July 2, 2026
Tenax Therapeutics, Inc. announced that results from its Phase 3 LEVEL clinical trial evaluating TNX-103 (oral levosimendan) will be presented during a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026, taking place August 28–31 in Munich, Germany. The company recently submitted the abstract in anticipation of completing its initial data analysis and now expects to report topline Phase 3 results in August 2026 before the conference presentation. Tenax stated that it is progressing toward the planned database lock and statistical analysis, marking a major milestone for the registrational study evaluating TNX-103 in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). The presentation will be delivered by Professor Sanjiv Shah, MD, of Northwestern University, highlighting one of the most anticipated cardiovascular clinical updates at the ESC Congress.
LEVEL Trial Designed to Support Registration of TNX-103
The LEVEL (NCT05983250) study is a registrational Phase 3 clinical trial evaluating TNX-103 (oral levosimendan) in patients with PH-HFpEF across the United States and Canada. Patient enrollment exceeded 230 participants and was successfully completed in March 2026, positioning the study for final efficacy analysis. The trial’s primary endpoint is the change in 6-minute walk distance (6MWD), a widely accepted measure of exercise capacity in cardiopulmonary diseases. In December 2025, a pre-specified Blinded Sample Size Re-estimation (BSSR) confirmed that the study maintained well over 90% statistical power to detect a 25-meter improvement in 6MWD, supporting the robustness of the trial design and increasing confidence in its ability to generate clinically meaningful results.
ESC Presentation Highlights Importance of Phase 3 Findings
Selection of the LEVEL trial for a Late-Breaking Clinical Science session at ESC Congress 2026 reflects the scientific significance of the study within the cardiovascular research community. The presentation, titled “Levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection fraction: results of the LEVEL trial,” is scheduled for August 29, 2026, in Munich, Germany. Late-breaking sessions at ESC are reserved for studies expected to influence clinical practice and future treatment strategies. With topline data expected before the congress, clinicians and investors will closely watch whether TNX-103 demonstrates meaningful improvements in exercise capacity and clinical outcomes for patients living with PH-HFpEF, a condition that currently lacks approved pharmacological therapies.
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Tenax Advances Therapy for a Major Unmet Cardiovascular Need
Tenax Therapeutics is a Phase 3 development-stage pharmaceutical company focused on advancing innovative therapies for cardiopulmonary diseases. The company holds global development and commercialization rights to levosimendan, which it is developing as TNX-103 for PH-HFpEF, the most common form of pulmonary hypertension worldwide. Despite its growing prevalence and significant impact on patient morbidity and mortality, no therapy has yet been approved specifically for PH-HFpEF, creating a substantial unmet medical need. Successful results from the LEVEL Phase 3 trial could position TNX-103 as a potential first-in-class treatment option while supporting future regulatory submissions and expanding therapeutic options for patients with this challenging cardiovascular condition.
Source: Tenax Therapeutics press release
