---
schema_version: "secwatch.filing_event.v1"
accession: "0001654954-23-009414"
form_type: "8-K"
ticker: "TENX"
cik: "0000034956"
company_name: "TENAX THERAPEUTICS, INC."
filed_at: "2023-07-19T23:59:59+00:00"
generated_at: "2026-06-13T06:36:14.514018+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Tenax Therapeutics receives U.S. patent for oral levosimendan (TNX-103) in PH-HFpEF, expiring 2040

## Summary
- USPTO granted Patent No. 11,701,355 for oral levosimendan (TNX-103) to treat PH-HFpEF, with exclusivity through December 2040.
- No FDA-approved treatments exist for PH-HFpEF, which affects over 1.6 million North Americans, projected to exceed 2 million by 2030.
- Phase 2 HELP study showed statistically significant improvement in 6-minute walk distance for levosimendan.
- Tenax intends to initiate a Phase 3 trial of TNX-103 in 2023, planning to demonstrate efficacy in this underserved patient population.
- Patent builds on existing IP for IV and subcutaneous levosimendan formulations for PH-HFpEF.

## SEC filing metadata
- accession: 0001654954-23-009414
- form_type: 8-K
- ticker: TENX
- cik: 0000034956
- company_name: TENAX THERAPEUTICS, INC.
- filed_at: 2023-07-19T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/34956/000165495423009414/0001654954-23-009414-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/34956/000165495423009414/tenx_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001654954-23-009414
- JSON: https://secwatch.observer/filing/0001654954-23-009414.json
- Plain text: https://secwatch.observer/filing/0001654954-23-009414.txt

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