Tenax Therapeutics to present LEVEL Phase 3 data at ESC 2026
Tenax Therapeutics has confirmed that results from its Phase 3 LEVEL trial will feature in a late-breaking clinical science session at the European Society of Cardiology Congress 2026, scheduled for 29 August in Munich. The company expects to report topline data in August 2026, with database lock and statistical analysis to be completed in the weeks prior to that readout.
The LEVEL trial (NCT05983250) is evaluating TNX-103, an oral formulation of levosimendan, in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). Enrolment of more than 230 patients across sites in the United States and Canada was completed in March 2026. The primary endpoint is change from baseline in six-minute walk distance (6MWD), a standard measure of functional capacity in cardiopulmonary indications.
A prespecified blinded sample-size re-estimation conducted in December 2025 found the trial is powered at well over 90% to detect a 25-metre improvement in 6MWD, providing some reassurance on trial design ahead of the readout. The abstract was submitted to ESC in anticipation of results being available in time for the congress.
The ESC presentation will be delivered by Professor Sanjiv Shah of Northwestern University on 29 August at 11:15 CEST.
Addressing an unmet need
PH-HFpEF is described by Tenax as the most prevalent form of pulmonary hypertension worldwide, and no therapy has yet received regulatory approval specifically for the condition. This leaves a meaningful unmet need that several development-stage companies have sought to address over the past decade, with limited success. The preserved-ejection-fraction phenotype of heart failure has proved particularly challenging to treat, with multiple large trials in the broader HFpEF population failing to show benefit on hard endpoints.
Levosimendan is an inotrope and vasodilator with a long history of intravenous use in acute decompensated heart failure in Europe, though it is not approved in the United States for any indication. Tenax holds global rights to develop and commercialise the compound and is pursuing the oral formulation specifically for the PH-HFpEF indication, a narrower and more mechanistically defined patient group than those studied in previous levosimendan programmes.
Regulatory and competitive context
A positive Phase 3 readout would position Tenax to engage with the US Food and Drug Administration on a new drug application, though the company has not yet publicly outlined a regulatory filing timeline. The 6MWD endpoint is an accepted primary measure in pulmonary arterial hypertension programmes, and its use in PH-HFpEF is broadly in line with FDA guidance in cardiopulmonary disease, though regulators have at times required haemodynamic or outcomes data to support approval in adjacent indications.
The late-breaking designation at ESC carries some clinical credibility; the congress selects sessions on the basis of scientific importance and the expectation of practice-changing findings. Whether LEVEL's results meet that bar will become clear when topline data are released in August, likely several days before the formal presentation. For investors, the August readout represents a binary catalyst for the Nasdaq-listed company, which remains in the development stage and carries the financing risks common to single-asset clinical-stage biotechs.