---
schema_version: "secwatch.filing_event.v1"
accession: "0001654954-23-014103"
form_type: "8-K"
ticker: "TENX"
cik: "0000034956"
company_name: "TENAX THERAPEUTICS, INC."
filed_at: "2023-11-13T23:59:59+00:00"
generated_at: "2026-06-08T05:49:49.056734+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA clears IND for Tenax's TNX-103 (oral levosimendan) for PH-HFpEF; Phase 3 LEVEL study to start Q4 2023

## Summary
- FDA cleared IND for TNX-103 (oral levosimendan) to treat PH-HFpEF, enabling Phase 3 LEVEL study in Q4 2023.
- FDA agreed to 6-minute walk distance as primary endpoint; no requirement for cardiovascular outcomes trial.
- Patent protection for oral levosimendan in PH-HFpEF until end of 2040; no FDA-approved treatments exist.
- More than 2/3 of research sites selected; 90% of prior HELP study sites agreed to participate.
- Estimated North American patient population >2 million by 2030; high unmet medical need.

## SEC filing metadata
- accession: 0001654954-23-014103
- form_type: 8-K
- ticker: TENX
- cik: 0000034956
- company_name: TENAX THERAPEUTICS, INC.
- filed_at: 2023-11-13T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/34956/000165495423014103/0001654954-23-014103-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/34956/000165495423014103/tenx_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001654954-23-014103
- JSON: https://secwatch.observer/filing/0001654954-23-014103.json
- Plain text: https://secwatch.observer/filing/0001654954-23-014103.txt

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