Long-Term Open-Label Extension Study of Oral Levosimendan

Tenax Therapeutics

Status and phase: Invitation-only; Phase 3

Conditions: Pulmonary Hypertension Associated With HFpEF

Treatments: Drug: TNX-103

Study type: Interventional

Funder types: Industry

Identifiers

NCT07436689

TNX-103-08

Details and patient eligibility

About

The purpose of this study is to provide continued access to treatment with oral levosimendan (TNX-103) and to describe the safety of continued use of TNX-103 in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) who received TNX-103 in a parent study.

Enrollment: 800 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed a TNX-103 parent study
• Investigator confirmation that participant may derive clinical benefit from continued access to TNX-103
• Requirements related to childbearing potential, contraception, and egg/sperm donation

Exclusion criteria

• Investigator or Sponsor opinion that the participant is unsuitable due to safety, inability to comply, or factors that could compromise study integrity or participant well-being
• Severe hepatic impairment or cirrhosis (Child-Pugh C) or active untreated hepatitis B or C with evidence of recent infection or viral replication
• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²
• Pregnancy or breastfeeding in females

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

800 participants in 1 patient group

TNX-103

Experimental group

Description:

Open-label oral levosimendan 1-3mg

Treatment:

Drug: TNX-103