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

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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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 22 Dec 2025

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At a glance

  • Drugs Levosimendan (Primary)
  • Indications Heart failure; Pulmonary hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms LEVEL-2
  • Sponsors Tenax Therapeutics

Most Recent Events

  • 17 Dec 2025 According to Tenax Therapeutics media release, this trial will provide the FDA and other global regulators a robust safety database to support their ultimate risk/benefit analysis at the approval stage.
  • 17 Dec 2025 According to Tenax Therapeutics media release, the company has selected over 100 sites across 15 countries so far to participate in LEVEL-2. Feasibility data suggests a total enrollment timeline of approximately 2 years
  • 13 Aug 2025 According to Tenax Therapeutics media release, the protocol for LEVEL-2 has been finalized, and the study will have a global footprint. To date, over 85 sites new to the program, in 15 additional countries, have received qualification visits.

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