Trials / Enrolling By Invitation
Enrolling By InvitationNCT07436689
Long-Term Open-Label Extension Study of Oral Levosimendan
A Multicenter, Open-Label, Long-Term Extension Study for Oral Levosimendan (TNX-103)
- Status
- Enrolling By Invitation
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- Sponsor
- Tenax Therapeutics, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TNX-103 | Open-label oral levosimendan 1-3mg |
Timeline
- Start date
- 2026-03-13
- Primary completion
- 2029-03-01
- Completion
- 2029-03-01
- First posted
- 2026-02-27
- Last updated
- 2026-03-19
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07436689. Inclusion in this directory is not an endorsement.