A Phase 3 interventional study of TNX-103 in Pulmonary Hypertension Associated With HFpEF, sponsored by Tenax Therapeutics, Inc.. Enrolling by invitation at 9 sites in United States. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Tenax Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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.
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's planned enrollment of 800 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Tenax Therapeutics, Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Open-label oral levosimendan 1-3mg
Drug: TNX-103
Open-label oral levosimendan 1-3mg
The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs
The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs will be tabulated by system organ class and preferred term.
Time frame: From enrollment through study completion (up to 3 years)
Plan to share: No
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Tenax Therapeutics, Inc.