---
schema_version: "secwatch.filing_event.v1"
accession: "0001654954-24-001465"
form_type: "8-K"
ticker: "TENX"
cik: "0000034956"
company_name: "TENAX THERAPEUTICS, INC."
filed_at: "2024-02-08T23:59:59+00:00"
generated_at: "2026-06-06T05:59:32.723847+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Tenax Therapeutics enrolls first patient in Phase 3 LEVEL study for TNX-103 in PH-HFpEF; topline data expected H2 2025

## Summary
- First patient enrolled in Phase 3 LEVEL study of oral TNX-103 (levosimendan) for PH-HFpEF; 152-patient trial.
- Over 40 U.S. and Canadian sites agreed to participate, including Mayo, Harvard, Northwestern.
- Topline data forecast for second half of 2025.
- FDA does not require long-term CV outcomes trial, reducing cost and time to registration.
- Patent estate protects TNX-103 through at least 2040.

## SEC filing metadata
- accession: 0001654954-24-001465
- form_type: 8-K
- ticker: TENX
- cik: 0000034956
- company_name: TENAX THERAPEUTICS, INC.
- filed_at: 2024-02-08T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/34956/000165495424001465/0001654954-24-001465-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/34956/000165495424001465/tenx_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001654954-24-001465
- JSON: https://secwatch.observer/filing/0001654954-24-001465.json
- Plain text: https://secwatch.observer/filing/0001654954-24-001465.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.