Tenax to present Phase 3 LEVEL trial data at ESC Congress 2026, expects topline results in August

Tenax Therapeutics, Inc. announced on July 2, 2026 that results from the Phase 3 LEVEL clinical trial will be presented in a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026, being held August 28-31 in Munich, Germany.¹

The timing follows a procedural step ahead of the meeting. An abstract was recently submitted in anticipation of potentially receiving topline results in time for the ESC presentation, and the company now expects to report data in August 2026, with database lock and statistical analysis to proceed in the weeks ahead.¹

The presentation is titled "Levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection fraction: results of the LEVEL trial," to be given by Professor Sanjiv Shah, MD, of Northwestern University, on Saturday, 29 August 2026, from 11:15 to 11:30 CEST at Messe München GmbH in Munich.¹

The trial itself, registered as LEVEL (NCT05983250), is a registrational Phase 3 clinical trial evaluating TNX-103 (oral levosimendan) in patients with pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) in the United States and Canada.¹ Enrollment of over 230 patients was completed in March 2026.¹

On the statistical design, a prespecified Blinded Sample Size Re-estimation conducted in December 2025 showed the trial is powered at well over 90% to detect a 25-meter change in 6-minute walk distance, the primary endpoint.¹

Tenax describes itself as a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, which owns global rights to develop and commercialize levosimendan for PH-HFpEF, described as the most prevalent form of pulmonary hypertension globally, for which no product has been approved to date.¹