Tenax Therapeutics Announces European Patent Office Intention to Grant Patent Covering Use of Levosimendan in PH-HFpEF

Rhea-AI Summary

Tenax Therapeutics (NASDAQ:TENX) announced that the European Patent Office (EPO) intends to grant a patent for the use of levosimendan, including TNX-103, in treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). The patent will provide protection through December 2040, with potential for extension beyond.

The patent will cover multiple administration routes including oral, intravenous, inhaled, transdermal, and subcutaneous use, as well as levosimendan's active metabolites. This development comes as Tenax prepares to launch its LEVEL-2 Phase 3 study in Europe, expanding their global clinical trial presence.

Positive

• Patent protection in Europe through at least 2040 for TNX-103 and other levosimendan formulations
• Patent covers multiple administration routes and active metabolites
• Strengthens global IP portfolio alongside existing US and Canadian patents
• Addresses a market with significant patient population comparable to North America

Negative

• Phase 3 trials still pending, indicating several years before potential commercialization
• Patent protection limited to Europe, requiring separate protection in other markets

Insights

Pharmaceutical Patent Expert

Tenax secures critical European patent protection for levosimendan in PH-HFpEF, strengthening commercial potential through 2040.

Tenax Therapeutics has received a significant intellectual property milestone with the European Patent Office's intention to grant a patent covering their lead candidate TNX-103 (oral levosimendan) for pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). This patent protection through at least 2040 substantially strengthens Tenax's commercial position in Europe, where the patient population rivals North America in size.

The scope of this patent is remarkably comprehensive, covering multiple administration routes (oral, intravenous, inhaled, transdermal, and subcutaneous), various dosage ranges, and even extending to levosimendan's active metabolites (OR1896 and OR1855). Additionally, the patent covers combination therapies with various cardiovascular drugs, creating a robust protective barrier around Tenax's treatment approach.

This patent grant is strategically timed as Tenax prepares to initiate its second Phase 3 study (LEVEL-2) with European patient recruitment. For a development-stage company like Tenax, this intellectual property protection is particularly valuable as it secures market exclusivity in a major territory, potentially attracting partnership opportunities and enhancing the company's negotiating position. The possibility of supplementary protection certificates (SPC) could extend exclusivity beyond 2040, further increasing the long-term value proposition.

This European patent complements Tenax's existing IP portfolio in the US and Canada, creating a coordinated global protection strategy for what could become a first-in-disease treatment for PH-HFpEF, a condition with significant unmet medical needs and no currently approved therapies.

Provides Patent Protection in Europe Through at Least December 2040

Further IP Protection for TNX-103 (Oral Levosimendan) and Other Drug Formulations, and its Active Metabolites, in PH-HFpEF

Also Provides Patent Protection for Wide Range of Levosimendan Doses, and its Use in Combination with Various Cardiovascular Drugs in PH-HFpEF

CHAPEL HILL, N.C., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, today announced that the European Patent Office (EPO) has notified Tenax of its Intention to Grant a patent that will provide intellectual property (IP) protection for TNX-103 (oral levosimendan), and other formulations of levosimendan, as well as its active metabolites, for use in pulmonary hypertension resulting from heart failure with preserved ejection fraction (PH-HFpEF). Once granted, this patent will provide Tenax with protection in Europe through 2040, and may qualify for an additional European patent term beyond 2040.

“This patent will protect our use of levosimendan in PH-HFpEF, including TNX-103, in Europe, where prevalence estimates indicate the number of patients currently suffering from this disease approximates the number estimated in North America. This patent protects an important commercial opportunity for Tenax. It builds on multiple patents already issued in the U.S. and Canada, as we continue to strengthen the global IP portfolio of our novel and potentially first-in-disease drug,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “The European patent is particularly timely for the Company as we prepare to initiate our second registrational Phase 3 study, LEVEL-2, which will recruit patients across Europe. We expect to initiate LEVEL-2 this year, an essential step not only in advancing TNX-103 toward regulatory approval in PH-HFpEF, but also to including patients from around the world at the Phase 3 stage of development.”

The EPO issued an Intention to Grant notification for Tenax’s patent application titled “LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF).” Once granted, this patent will include claims covering the use of levosimendan when delivered through various routes of administration to treat PH-HFpEF, including oral, intravenous, inhaled, transdermal, and subcutaneous use. In addition, this patent will include similar protection for the use of the active metabolites of levosimendan (OR1896 and OR1855) for the treatment of PH-HFpEF. This patent also will expressly provide protection in Europe for a wide range of doses of levosimendan, as well as for use of levosimendan in combination with various cardiovascular drugs, in PH-HFpEF. This new patent, once granted, will have a patent term until December 2040, and it may qualify for European patent supplementary protection certificates (SPC) that would extend the period of patent protection beyond 2040.

About Levosimendan (TNX-101, TNX-102, TNX-103)

Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (PH-HFpEF). Levosimendan was first developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and it has received market authorization in 60 countries in this indication, although it is not available in the United States or Canada. Tenax’s Phase 2 HELP study, including its open-label extension stage, demonstrated the potential of IV (TNX-101) and oral (TNX-103) levosimendan to bring durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL, a Phase 3, double-blind, randomized, placebo-controlled clinical trial in patients with PH-HFpEF.

About Tenax Therapeutics

Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company owns global rights to develop and commercialize levosimendan, which it is developing for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension globally, for which no product has been approved to date. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.

Caution Regarding Forward-Looking Statements

Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning expected intellectual property developments and possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: intellectual property risks; risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, location, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; risks related to our business strategy, including the prioritization and development of product candidates; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; the potential advantages of our product candidates; our competitive position; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; risks associated with our cash needs; volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.

Contact:

Investor and Media:

Argot Partners
tenax@argotpartners.com

FAQ

What patent protection did Tenax Therapeutics (TENX) receive for levosimendan in Europe?

The European Patent Office intends to grant a patent protecting TNX-103 and other levosimendan formulations for PH-HFpEF treatment through December 2040, with potential extension beyond.

What medical conditions will Tenax's TNX-103 treat?

TNX-103 is being developed to treat pulmonary hypertension resulting from heart failure with preserved ejection fraction (PH-HFpEF).

When will Tenax Therapeutics start the LEVEL-2 Phase 3 trial?

Tenax expects to initiate the LEVEL-2 Phase 3 study in Europe by the end of 2025.

What administration methods are covered by Tenax's European patent?

The patent covers multiple administration routes including oral, intravenous, inhaled, transdermal, and subcutaneous use, as well as levosimendan's active metabolites.

How large is the European market potential for Tenax's PH-HFpEF treatment?

According to Tenax, the European patient population for PH-HFpEF is comparable in size to North America.