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Pulmonary Hypertension Associated With Hfpef / TNX-103 · Phase 3 Trial
ClinicalTrials.gov · August 19, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 registration for a randomized, placebo-controlled trial of oral levosimendan (TNX-103) in patients with pulmonary hypertension and heart failure with preserved ejection fraction. The trial is currently recruiting and has not reported results; it is designed to measure efficacy via 6-minute walk distance at 26 weeks but provides no evidence of benefit or harm at this stage.
Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Pulmonary Hypertension Associated With HFpEF; age from 18 Years; to 85 Years. Intervention: TNX-103. Compared with: Placebo — Placebo Comparator. n = 540. 141 sites across 15 countries.
Planned enrollment: 540 participants Primary endpoint: change in 6-Minute Walk Distance at 26 weeks Intervention: oral levosimendan (TNX-103)
Primary outcome measure is functional (6MWD) not a hard clinical outcome such as mortality or hospitalization. Study duration (26 weeks follow-up) and long-term safety profile not yet reported.
Clinicians should not alter practice on the basis of this registration record. Results must be awaited to determine whether levosimendan improves functional capacity in this population.
This is a Phase 3 clinical trial currently recruiting with no results posted; it describes a planned study design and endpoints, not evidence of efficacy or safety.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should not alter practice on the basis of this registration record. Results must be awaited to determine whether levosimendan improves functional capacity in this population.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT07288398). This is a study registration, not published results. Lead sponsor: Tenax Therapeutics, Inc.. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 540 participants (ESTIMATED). Conditions: Pulmonary Hypertension Associated With HFpEF. Interventions: DRUG: TNX-103; DRUG: Placebo. Primary outcome measures: 6-Minute Walk Distance (6MWD) , 26 weeks. Brief summary: The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.