Tenax Therapeutics ((TENX)), Medpace Holdings Inc ((MEDP)) announced an update on their ongoing clinical study.
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Tenax Therapeutics, in collaboration with Medpace Holdings and Northwestern University, is conducting a pivotal Phase 3 clinical study titled ‘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)’. The study aims to assess the effectiveness of TNX-103 (oral levosimendan) in improving exercise capacity in patients with PH-HFpEF, measured by the change in 6-Minute Walk Distance over 12 weeks. This research is significant as it targets a challenging condition with limited treatment options.
The intervention under investigation is TNX-103, an oral form of levosimendan, which is being compared to a placebo. Levosimendan is designed to enhance heart function and improve exercise tolerance in affected patients.
This interventional study employs a randomized, double-blind, placebo-controlled design with a parallel assignment. The primary purpose is treatment, and the study uses quadruple masking to ensure unbiased results, involving participants, care providers, investigators, and outcomes assessors.
The study began on August 1, 2023, with an anticipated primary completion date in 2025. The last update was submitted on August 15, 2025, indicating ongoing recruitment and progress.
The outcome of this study could significantly impact Tenax Therapeutics’ stock performance and investor sentiment, as successful results may position TNX-103 as a leading treatment for PH-HFpEF. This could also influence the competitive landscape, prompting responses from other companies in the cardiovascular treatment sector.
The study is currently recruiting, with further details available on the ClinicalTrials portal.