Tenax Therapeutics is conducting a long-term open-label extension study of TNX-103, an oral formulation of levosimendan, in patients with pulmonary hypertension associated with heart failure and preserved Ejection Fraction (HFpEF), Group 2 of the World Health Organisation classification. In its intravenous form TNX-103 is a drug authorized for use in 60 countries for acute decompensated heart failure (ADHF).
The primary purpose of the long-term open-label extension study is to continue treatment for participants who completed an earlier Tenax study while monitoring safety over an extended period — data that will be valuable for both regulators and potential partners.
The drug works by improving cardiac efficiency, offering a potential option for a patient population that currently has few therapeutic alternatives. It aims to relieve symptoms and enhance functional capacity in this underserved group.
As a single-arm, open-label Phase 3 extension, the study has no placebo group — all eligible participants receive TNX-103, and both patients and their clinicians are aware of the treatment being administered.
The study was first registered on February 20, 2026, with a protocol update filed just five days later on February 25, 2026, confirming that the extension phase is actively underway and that enrolment information is current.
Read more at this link on the Tenax website