Complete Announced during: Premarket · announced Mon 7:19a ET (premarket); before = Fri close; first trade Mon 7:20a ET; time = SEC 8-K acceptance
Tenax Therapeutics (Nasdaq: TENX) reported topline results from a Phase 3 trial of TNX-103 in PH-HFpEF on August 10, 2026. The company said the trial did not meet its primary endpoint. ClinicalTrials.gov lists 230 planned participants (NCT05983250).
Trial details
- Drug
- TNX-103Type Drug Route oral
- Treats
- Studied as a treatment for PH-HFpEF (registry condition: Pulmonary Hypertension).Condition Pulmonary Hypertension
- Patients
- 230 patients (anticipated enrollment)2 arms · 42 sites in 2 countries
- Phase
- Phase 3
- Design
- Randomized, quadruple-blind, placebo-controlled, parallel-group
- Primary endpoint
- Change in Six-minute walk distance (12 weeks)
- Key secondary endpoints
- KCCQ
- Clinical Worsening Events
- Change in NT-proBNP
- Result
- Missed endpointLEVEL did not meet its primary endpoint of improvement in the 6-minute walk distance versus placebo, or the key secondary endpoint of improvement in Kansas City Cardiomyopathy Questionnaire total symptom score.
- Safety
- TNX-103 was generally safe and well tolerated, with serious adverse events and adjudicated clinical worsening events balanced across treatment arms.
- Sponsor
- Tenax Therapeutics Nasdaq: TENXCollaborators Medpace, Inc., Northwestern University
- Dates
- Study start Jan 10, 2024Primary completion Jun 30, 2026Announced Aug 10, 2026, 7:19 AM ET (SEC 8-K filing time)
- Trial ID
- NCT05983250 ClinicalTrials.gov
About this trial
This randomized, quadruple-blind, placebo-controlled, parallel-group Phase 3 trial (NCT05983250) tested TNX-103 in Pulmonary Hypertension. Studied as a treatment for PH-HFpEF (registry condition: Pulmonary Hypertension). It planned to enroll 230 patients across 2 arms at 42 sites in 2 countries. The primary endpoint was Change in Six-minute walk distance (12 weeks). Tenax Therapeutics reported that the trial did not meet its primary endpoint. The study started on Jan 10, 2024 and reached primary completion on Jun 30, 2026. The lead sponsor is Tenax Therapeutics, with Medpace, Inc. and Northwestern University as collaborators.
Sources
- Source: SEC EDGAR 8-K (EX-99.1)
- ClinicalTrials.gov record: NCT05983250
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