Long-Term Open-Label Extension Study of Oral Levosimendan

A Multicenter, Open-Label, Long-Term Extension Study for Oral Levosimendan (TNX-103)

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.

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