Tenax Therapeutics Advances Phase 3 Study on Levosimendan for PH-HFpEF

Tenax Therapeutics (TENX) announced an update on their ongoing clinical study.

Tenax Therapeutics (TENX) is actively recruiting participants for its LEVEL-2 clinical study titled LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2. This Phase 3 study aims to evaluate the efficacy and safety of oral levosimendan (TNX-103) compared to placebo in improving exercise tolerance among individuals with pulmonary hypertension (PH) and heart failure with preserved ejection fraction (HFpEF). The study’s goal, measured by the change in 6-Minute Walk Distance, underscores its importance in addressing quality of life for patients with limited treatment options.

The study evaluates levosimendan (TNX-103), delivered orally, which is designed to alleviate exercise limitations by targeting pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF).

The clinical trial is randomized, double-blinded (quadruple masking), and placebo-controlled, with participants divided into two groups—levosimendan and placebo—to ensure unbiased results. The parallel intervention model emphasizes levosimendan’s treatment potential.

Key dates include the study’s initial submission on December 15, 2025, which also marks the latest update. The primary completion date and estimated overall completion date have not yet been disclosed, emphasizing its early recruitment phase.

This update could bolster investor confidence in Tenax Therapeutics, given the strategic focus on addressing unmet medical needs in PH-HFpEF. Depending on trial outcomes, successful results might enhance TENX’s market positioning amidst a competitive broader pharmaceutical sector working on heart-related therapies.

The trial is ongoing, with updated details accessible on the ClinicalTrials platform.

To learn more about TENX’s potential, visit the Tenax Therapeutics drug pipeline page.