Trial Profile

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 04 Sep 2026

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At a glance

29 Aug 2026 According to Tenax Therapeutics media release, data form this trial were published in at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany.
29 Aug 2026 Results presented in the Tenax Therapeutics media Release.
14 Aug 2026 According to Tenax Therapeutics media release, Based on the results of the LEVEL trial, The company intends to request a Type C Meeting with the U.S. Food and Drug Administration (FDA) to discuss revisions to the ongoing registrational development of TNX-103 for the treatment of PH-HFpEF. The company will discuss an enrichment strategy in the Type C meeting, and about sufficient data for NDA submission.

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