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Pulmonary Hypertension Associated With Hfpef / TNX-103 · Phase 3 Trial
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 open-label extension registry record for an investigational oral levosimendan (TNX-103) in pulmonary hypertension with heart failure with preserved ejection fraction. No results are posted; the study is currently enrolling by invitation and aims to characterise safety over up to 3 years of continued treatment in prior trial participants.
Phase 3, Interventional, Single Group, Open label, Treatment purpose. Pulmonary Hypertension Associated With HFpEF. Intervention: TNX-103. n = 800. 9 sites: United States.
This is a Phase 3 open-label extension registry record for an investigational oral levosimendan (TNX-103) in pulmonary hypertension with heart failure with preserved ejection fraction. No results are posted; the study is currently enrolling by invitation and aims to characterise safety over up to 3 years of continued treatment in prior trial participants.
Open-label design without control arm limits ability to attribute safety signals to drug or natural history. Primary outcome is incidence of adverse events; efficacy or clinical benefit is not measured.
This record provides no clinical guidance because results are not yet available. Clinicians should monitor for updates when the study is completed; the long-term safety profile of oral levosimendan in this population remains to be established.
This is a Phase 3 open-label extension study with no results posted; it is a registry record describing an ongoing trial designed to assess safety over continued exposure, not efficacy against a comparator.
As stated by the source record.
Quoted from the source exactly as published.
This record provides no clinical guidance because results are not yet available. Clinicians should monitor for updates when the study is completed; the long-term safety profile of oral levosimendan in this population remains to be established.
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.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07436689). This is a study registration, not published results. Lead sponsor: Tenax Therapeutics, Inc.. Recruitment status: ENROLLING_BY_INVITATION. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 800 participants (ESTIMATED). Conditions: Pulmonary Hypertension Associated With HFpEF. Interventions: DRUG: TNX-103. Primary outcome measures: The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs , From enrollment through study completion (up to 3 years). Brief summary: The purpose of this study is to provide continued access to treatment with oral levosimendan (TNX-103) and to describe the safety of continued use of TNX-103 in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) who received TNX-103 in a parent study.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.