Tenax Therapeutics Reaches 230-Patient Phase 3 Milestone, Eyes Q3 2026 Data
Tenax Therapeutics achieved its randomization target of 230 patients in the Phase 3 LEVEL trial and expects topline data in the third quarter of 2026. The company has launched a global Phase 3 LEVEL-2 trial, opened an open-label extension study and holds $97.6 million cash to fund operations into 2027.
1. Phase 3 LEVEL Study Randomization Target
Tenax Therapeutics has achieved randomization of 230 patients in its Phase 3 LEVEL trial and closed the screening period, marking completion of its enrollment target this month. The company expects to finalize randomization for screened patients by end of March and to announce topline data in the third quarter of 2026.
2. Global LEVEL-2 Trial and Open-Label Extension
In parallel, Tenax launched the global Phase 3 LEVEL-2 trial in December 2025 to further evaluate oral levosimendan (TNX-103) in patients with pulmonary hypertension associated with HFpEF. An open-label extension study has also opened, allowing participants from both LEVEL and LEVEL-2 studies continued access to TNX-103 until potential commercial availability.
3. Patent Notice Expands Levosimendan Protection
In January 2026, the U.S. Patent and Trademark Office issued a Notice of Allowance expanding protection to subcutaneous formulations of levosimendan across multiple cardiac and pulmonary indications, including pulmonary hypertension, HFpEF and HFrEF. This patent expansion strengthens exclusive rights for Tenax’s novel therapy through a broad range of applications.
4. Financial Results and Cash Runway
Tenax ended 2025 with $97.6 million in cash and equivalents, sufficient to fund operations into 2027. Fourth-quarter R&D expenses rose to $10.5 million and net loss widened to $15.5 million, reflecting increased trial activity and higher administrative costs driven by staff expansion and professional fees.