Tenax Therapeutics is a clinical-stage pharmaceutical company focused entirely on developing oral levosimendan (TNX-103) for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF), a condition affecting an estimated 1.5M+ U.S. patients with no currently approved treatment. Levosimendan itself is not new — it has been approved in 60 countries for intravenous use in acute heart failure for over 20 years — but Tenax is developing a novel oral capsule formulation for chronic daily use. Tenax holds an exclusive global license from Orion, the Finnish developer of levosimendan, covering oral and subcutaneous formulations worldwide, plus IV rights in the U.S. and Canada. Tenax's pipeline centers on two ongoing Phase 3 trials: LEVEL (initiated Q4 2023, U.S. and Canada) and LEVEL-2 (initiated December 2025, global), both testing TNX-103 against placebo with 6-minute walk distance as the primary endpoint. Tenax plans to submit an NDA following positive results from both trials. The company has no revenue and funds operations entirely through equity raises, with approximately $125M raised across 2024 and 2025 to fund trials through completion and NDA submission. Tenax has 14 employees, outsources all manufacturing to third parties, and relies on Orion as the sole supplier of levosimendan active ingredient. A secondary candidate, TNX-201 (oral imatinib for pulmonary arterial hypertension), has been deprioritized.
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