Tenax Hits Key Milestone in Quest for First-Ever PH-HFpEF Heart Drug

CHAPEL HILL, NC – March 10, 2026 – Tenax Therapeutics announced today it has reached a critical milestone in the development of a potential first-in-class therapy for a debilitating and untreated form of heart disease. The company has successfully randomized its target of 230 patients in its pivotal Phase 3 LEVEL study, a significant step forward for its drug candidate, TNX-103 (oral levosimendan).

The achievement puts the Chapel Hill-based pharmaceutical firm on track to report topline data in the third quarter of 2026. This data will be closely watched by clinicians, investors, and patients suffering from pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF), a condition for which there are currently no approved treatments.

“We are pleased to announce that we have recently achieved our randomization target of 230 patients in the Phase 3 LEVEL study,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics, in a statement. “As we strive to make significant progress executing on our registrational LEVEL program, achievement of this important milestone demonstrates our team’s commitment to rapidly advancing TNX-103.”

Addressing a Critical Unmet Need

PH-HFpEF is a severe and progressive disease that represents a major therapeutic void in cardiovascular medicine. It occurs when the heart's left ventricle becomes stiff and cannot properly fill with blood, leading to a pressure backup in the lungs. This pulmonary hypertension places immense strain on the right side of the heart, leading to debilitating symptoms like shortness of breath and fatigue, and significantly reduces a patient's ability to perform everyday activities.

Research indicates that pulmonary hypertension is alarmingly common in the broader heart failure population, affecting up to 80% of patients with HFpEF. The prognosis for these individuals is starkly poor, with the presence of PH being a well-established factor for worse outcomes and a two- to three-fold increased risk of mortality. Despite the immense patient population and the severity of the disease, a long line of potential therapies has failed to demonstrate a clear benefit, leaving physicians with limited options beyond managing symptoms and comorbidities.

This landscape of clinical trial failures makes Tenax’s progress particularly noteworthy. If successful, TNX-103 could be the first drug ever approved specifically to treat this condition, offering hope to a large and desperate patient community.

The Science of a Second Chance

Levosimendan, the active compound in TNX-103, is not a new molecule. It is already approved in an intravenous form in over 60 countries for treating hospitalized patients with acutely decompensated heart failure. Tenax is pioneering its use in a new, oral formulation for the chronic treatment of PH-HFpEF.

The drug possesses a unique dual mechanism of action that differentiates it from other heart failure medications. First, it acts as a “calcium sensitizer,” enhancing the heart’s pumping force without increasing oxygen demand—a crucial advantage in a weakened heart. Second, it opens potassium channels in blood vessels, causing them to relax and widen. This vasodilation reduces the pressure against which the heart must pump, easing its workload and improving blood flow.

Tenax’s previous Phase 2 HELP study provided encouraging signals for this approach. While the trial narrowly missed its primary hemodynamic endpoint, it demonstrated a statistically significant improvement in a key functional measure: the six-minute walk distance. Patients on levosimendan walked, on average, 29.3 meters farther than those on placebo, a clinically meaningful improvement in exercise capacity that forms the basis of the primary endpoint for the current Phase 3 LEVEL study.

The High-Stakes Path to Approval

Bringing a drug to market is a long and costly endeavor, and Tenax’s financial reporting underscores the high-stakes nature of late-stage development. The company reported a net loss of $52.6 million for 2025, a substantial increase from $17.6 million in 2024. This surge in spending is driven by escalating research and development costs, which climbed to $32.7 million for the year as the company ramped up its ambitious clinical program.

This program includes not only the now-enrolled LEVEL study but also a second, global Phase 3 trial, LEVEL-2, which was initiated in December 2025. Running two large, registrational trials is a standard but expensive strategy designed to generate the robust data package required for regulatory approval in the U.S. and other major markets. The company also launched an open-label extension study, allowing trial participants to continue receiving TNX-103 long-term, a move that aids in patient retention and provides valuable long-term safety data.

Despite the heavy spending, Tenax appears well-capitalized to see its strategy through. The company ended 2025 with $97.6 million in cash and cash equivalents, which it projects will fund operations through 2027. This financial runway, secured through significant private placements in 2024 and 2025, is critical as it allows the company to focus on execution without the immediate pressure of raising additional funds.

Fortifying a First-Mover Advantage

While advancing its clinical trials, Tenax has also been shoring up its strategic position. In January 2026, the U.S. Patent and Trademark Office issued a Notice of Allowance for a patent covering the subcutaneous administration of levosimendan for a broad range of heart failure and pulmonary hypertension indications. This strengthens the company's intellectual property fortress around the molecule, potentially extending its market exclusivity and creating barriers for future competitors.

With no other drugs currently approved for PH-HFpEF and few visible late-stage competitors for this specific indication, Tenax is poised to have a first-mover advantage if its trials succeed. The path ahead still holds challenges, including navigating the complex regulatory approval process and, eventually, convincing payers of the drug's value to secure market access and reimbursement.

For now, all eyes are on the third quarter of 2026. The release of the LEVEL study's topline data will be a watershed moment for Tenax Therapeutics. A positive result could transform the treatment paradigm for millions of heart failure patients and solidify the company’s place as a leader in cardiopulmonary medicine, while a negative one would represent a significant setback for the field.