Orion’s license partner Tenax Therapeutics’ Phase 3 LEVEL trial of oral levosimendan in pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) did not reach its primary endpoint

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Orion’s license partner Tenax Therapeutics’ Phase 3 LEVEL trial of oral levosimendan in pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) did not reach its primary endpoint

Orion Corporation’s license partner Tenax Therapeutics, Inc., today announced that the Phase 3 LEVEL clinical trial evaluating oral levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) did not reach its primary endpoint of improvement in the 6-minute walk distance versus placebo, or the key secondary endpoint of improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score.

According to Tenax, prespecified subgroup analyses identified a substantial beneficial treatment effect in patients with greater disease burden, supported by clinically meaningful changes in predefined cardiac biomarker and pulmonary hemodynamic measures across the overall trial population. Oral levosimendan was generally safe and well tolerated, with serious adverse events and adjudicated clinical worsening events balanced across treatment arms. Based on the results of the LEVEL trial, Tenax intends to request a Type C Meeting with the U.S. Food and Drug Administration (FDA) to discuss revisions to the ongoing registrational development of levosimendan for the treatment of PH-HFpEF, and to seek parallel scientific consultation from the European Medicines Agency.

Further details on the Phase 3 LEVEL clinical trial topline results can be found on Tenax Therapeutics' website at https://www.tenaxthera.com.

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Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals as well as active pharmaceutical ingredients, combining our trusted expertise with continuous innovation. We have an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by us are used to treat cancer, respiratory diseases and neurological diseases, among others. In 2025 our net sales amounted to EUR 1,890 million, and we employ about 4,000 professionals worldwide, dedicated to building well-being.