Tenax Therapeutics’ IND application for TNX-103 cleared by FDA

Tenax Therapeutics announced that the FDA has reviewed and cleared the company’s Investigational New Drug – IND – Application for TNX-103 oral levosimendan for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction – PH-HFpEF -, enabling Tenax to proceed with the first of two Phase 3 studies. The LEVEL Study is expected to launch in Q4 2023.