Tenax Therapeutics will present Phase 3 LEVEL trial data on oral levosimendan at ESC Congress on August 29 after enrolling 230+ PH-HFpEF patients by March 2026. A blinded sample-size re-estimation showed >90% power to detect a 25 m change in 6MWD, and the company expects topline results in August 2026.
Tenax Therapeutics secured a Late-Breaking Clinical Science session at ESC Congress 2026 in Munich on August 29 for detailed review of LEVEL trial outcomes. Professor Sanjiv Shah, MD from Northwestern University will deliver the 15-minute presentation on levosimendan’s impact in PH-HFpEF patients.
LEVEL (NCT05983250) is a registrational Phase 3 study evaluating oral levosimendan (TNX-103) in pulmonary hypertension due to heart failure with preserved ejection fraction across the U.S. and Canada. Enrollment of over 230 patients was completed in March 2026, meeting protocol targets for global registrational requirements.
A prespecified blinded sample-size re-estimation in December 2025 confirmed the trial is powered at well over 90% to detect a 25-meter improvement in six-minute walk distance, which serves as the primary efficacy endpoint.
The company plans to initiate database lock and statistical analysis in the coming weeks, with topline LEVEL results expected in August 2026 ahead of the ESC presentation.
