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: 26 Mar 2025
Price :
$35
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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
- 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.
- 05 Mar 2025 According to a Tenax Therapeutics media release, two registrational studies (LEVEL and LEVEL-1) will satisfy the requirements, including the safety data expectations, to file in the U.S. and other geographies.
- 05 Mar 2025 According to a Tenax Therapeutics media release, U.S. Food and Drug Administration (FDA) has completed their review of this trial and company received input from the FDA on the protocol for the LEVEL-2 study, and agreement by FDA to initiate this second global trial and company will be commencing study later this year, in several countries with first patient expected to be enrolled this year.