Long-Term Open-Label Extension Study of Oral Levosimendan

Recruitment Status
ENROLLING BY INVITATION
(See Contacts and Locations)Verified February 2026 by Tenax Therapeutics, Inc.
Sponsor
Tenax Therapeutics, Inc.
Information Provided by (Responsible Party)
Tenax Therapeutics, Inc.
Clinicaltrials.gov Identifier
NCT07436689
Other Study ID Numbers:
TNX-103-08
First Submitted
February 19, 2026
First Posted
February 26, 2026
Last Update Posted
March 18, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Pulmonary Hypertension Associated With HFpEF
Drug: TNX-103

Study Design

Study TypeInterventional
Actual Enrollment800 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Multicenter, Open-Label, Long-Term Extension Study for Oral Levosimendan (TNX-103)
Study Start DateMarch 12, 2026
Actual Primary Completion Date2yrs 7mos from now
Actual Study Completion Date2yrs 7mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
TNX-103
Open-label oral levosimendan 1-3mg
Drug: TNX-103
Open-label oral levosimendan 1-3mg

Outcome Measures

Primary Outcome Measures
  1. The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs
    The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs will be tabulated by system organ class and preferred term.

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsTenax Therapeutics, Inc.
Locations
Tenax Investigational Site | Chicago Illinois, United States, 60611Tenax Investigational Site | Minneapolis Minnesota, United States, 55455Tenax Investigational Site | Rochester Minnesota, United States, 55905Tenax Investigational Site | St Louis Missouri, United States, 63136Tenax Investigational Site | Charleston South Carolina, United States, 29425