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# Tenax’s TNX-103 Misses Primary Endpoint in Phase 3 Trial
- URL: https://www.fdaweb.com/tenaxs-tnx-103-misses-primary-endpoint-in-phase-3-trial/
- Published: 2026-08-10T12:00:00.000Z
- Updated: 2026-09-14T13:44:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161604

Tenax Therapeutics is reporting that its oral levosimendan candidate TNX-103 failed to meet the primary endpoint in a Phase 3 trial evaluating the treatment in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction.

In the LEVEL trial, TNX-103 did not meet statistical significance on the primary endpoint of improvement in 6-minute walk distance versus placebo, according to the company. The drug also failed to improve the key secondary endpoint, the Kansas City Cardiomyopathy Questionnaire total symptom score.

Tenax says its prespecified subgroup analyses suggested a greater treatment effect among patients with more advanced disease. Patients whose baseline six-minute walk distance was below the trial median of 333 meters had a 26.3-meter improvement versus placebo, it notes. TNX-103 also produced a 49% reduction in NT-proBNP, a protein present in the blood when the heart is stressed, compared with placebo and a 3.5 mmHg reduction in right ventricular systolic pressure in the overall population. The company cautioned that the nominal p-values were not adjusted for multiplicity and the exploratory analyses do not establish efficacy.

Tenax said it plans to request a Type C meeting with FDA to discuss the LEVEL results and potential changes to the drug’s registrational development program.

Levosimendan was originally developed by the Orion Corp., which submitted an NDA in 1998\. FDA rejected the submission and requested further trials be conducted and Orion withdrew the application in 1999\. Orion then obtained approval to market the drug in Sweden in 2000, and since then 60 countries worldwide have approved the drug for acute cardiac care.