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A second phase 3 trial of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

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Trial Profile

A second phase 3 trial of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 30 Oct 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

  • 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.
  • 13 Aug 2025 According to Tenax Therapeutics media release, company on track to initiate the study this year.
  • 25 Mar 2025 According to a Tenax Therapeutics media release, Company updated Phase 3 development plan for TNX-103 (oral levosimendan). The plan includes an amendment to expand enrollment and enhance the statistical power of the ongoing Phase 3 LEVEL study, as well as the protocol for LEVEL-2, companies second registrational Phase 3 study.

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