Tenax Therapeutics TENX

Tenax Therapeutics is a Phase 3, development-stage pharmaceutical company focused on developing novel cardiopulmonary therapies. The company uses a clinician-driven drug development approach, guided by key opinion leaders and heart failure experts to target disease pathophysiology with precision. Its primary activities involve conducting clinical trials for its lead product candidates, levosimendan and imatinib, to address pulmonary hypertension.

Tenax Therapeutics generates revenue through the potential commercialization of its product candidates, levosimendan and imatinib, which are being developed for the treatment of pulmonary hypertension. The company does not currently generate revenue from product sales as it remains in the clinical development stage. Revenue is expected to arise from future marketing authorization approvals and subsequent sales of its therapies to healthcare providers and patients.

Tenax Therapeutics operates through the following segments:

• Levosimendan Development: This segment focuses on the clinical development of levosimendan for the treatment of pulmonary hypertension, particularly in patients with heart failure with preserved ejection fraction (PH-HFpEF). The company is conducting the LEVEL and LEVEL-2 Phase 3 clinical trials to evaluate TNX-103, its oral formulation of levosimendan. These trials are being conducted in the United States and Canada, with the LEVEL study achieving full enrollment of 230 patients in March 2026.

• Imatinib Development: This segment involves the development of imatinib for pulmonary arterial hypertension (PAH) and other potential indications. Although imatinib has been deprioritized in favor of levosimendan, Tenax Therapeutics plans to initiate a Phase 3 trial for imatinib when appropriate, following the completion of its levosimendan program. The company believes imatinib’s established safety profile from over 20 years of global use supports its potential repurposing for pulmonary hypertension.

Tenax Therapeutics holds a specialized position in the cardiovascular and pulmonary hypertension therapeutic landscape, leveraging repurposed drugs with established safety profiles to reduce development risk. The company competes with other pharmaceutical firms developing novel and existing therapies for pulmonary hypertension, including United Therapeutics, Actelion (a Johnson & Johnson company), and Bayer. Its competitive advantage lies in its clinician-led development strategy and the use of de-risked, previously approved drug candidates, which may accelerate regulatory pathways and reduce uncertainty in clinical outcomes.

Tenax Therapeutics serves patients suffering from pulmonary hypertension, particularly those with heart failure with preserved ejection fraction (PH-HFpEF) and pulmonary arterial hypertension (PAH). The company’s therapies are intended for use in clinical settings such as hospitals and specialized cardiology centers, where patients receive diagnosis and treatment for advanced cardiovascular and pulmonary conditions.