Tenax Therapeutics Expands Phase 3 Study for TNX-103, Secures FDA Alignment

Tenax Therapeutics is making significant strides in the development of TNX-103, its oral levosimendan treatment for PH-HFpEF, following a positive review from the FDA. The company announced an expansion of its ongoing Phase 3 LEVEL study to include 230 patients, boosting the study's statistical power to over 95%. This move underscores Tenax’s confidence in the therapy’s potential and its commitment to robust clinical data. Additionally, the company plans to launch LEVEL-2, a second registrational Phase 3 trial, in 2025. With over 50 sites already activated in North America, Tenax anticipates completing enrollment for the LEVEL study by the end of the year while laying the groundwork for its global expansion.

Backed by $100 million in funding secured in August 2024, Tenax is well-positioned to advance TNX-103’s development and meet regulatory requirements in the U.S. and beyond. "With FDA alignment and strong momentum, we’re accelerating our plans to bring this therapy to patients," said CEO Chris Giordano. By running two Phase 3 studies in parallel, the company aims to satisfy safety and efficacy benchmarks necessary for approval. If successful, TNX-103 could offer a much-needed treatment for patients struggling with PH-HFpEF, improving their quality of life and addressing a significant unmet medical need.