FDA clears IND for Tenax's TNX-103 (oral levosimendan) for PH-HFpEF; Phase 3 LEVEL study to start Q4 2023

TENAX THERAPEUTICS, INC.

FDA cleared IND for TNX-103 (oral levosimendan) to treat PH-HFpEF, enabling Phase 3 LEVEL study in Q4 2023.
FDA agreed to 6-minute walk distance as primary endpoint; no requirement for cardiovascular outcomes trial.
Patent protection for oral levosimendan in PH-HFpEF until end of 2040; no FDA-approved treatments exist.
More than 2/3 of research sites selected; 90% of prior HELP study sites agreed to participate.
Estimated North American patient population >2 million by 2030; high unmet medical need.

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