Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TNX-103, Levosimendan
Levosimendan (TNX-103) · 6 trials · 10 indications
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.
Change in 6-minute walk distance
The all-cause death at 30 days or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) through Day 5
Composite of all-cause death (at 30 days), or perioperative nonfatal MI \[CK-MB \>10xULN or \>100 ng/mL, CK-MB \>5xULN or 50 ng/mL with new Q wave (\>0.04 seconds wide in two contiguous leads) or new left bundle branch block)\] (through Day 5), or need for renal dialysis (through Day 30), or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) (through Day 5)
Number of Adverse Events per Patient Population
Change from baseline Pulmonary Capillary Wedge Pressure (PCWP) with bicycle exercise at Week 6
| Arm | Type | Description |
|---|---|---|
| TNX-103 | EXPERIMENTAL | Open-label oral levosimendan 1-3mg |
| Placebo | PLACEBO_COMPARATOR | Matching placebo (oral) |
| Levosimendan | EXPERIMENTAL | levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours |
| Levosimendan Open-Label | OTHER | Initial: A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion. Ongoing patients are transitioned to daily oral levosimendan (1mg capsules TID) |
| Levosimendan 2.5mg/mL Injectable Solution | EXPERIMENTAL | 0.075 - 0.1µg/kg/min for 24 hrs (weekly) |
| Matching Placebo | PLACEBO_COMPARATOR | 0.075 - 0.1µg/kg/min for 24 hrs (weekly) |
| Name | Type | Description |
|---|---|---|
| TNX-103 | DRUG | Open-label oral levosimendan 1-3mg |
| Placebo | DRUG | Matching placebo (oral) |
| Levosimendan | DRUG | - |
| Matching Placebo | DRUG | A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion |
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 op...
Levosimendan (TNX-103) is being developed for pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF), as well as pulmonary hypertension and coronary artery bypass grafting. It is an investigational small molecule in Phase 3 development and has not been approved by the FDA.
Levosimendan (TNX-103) targets PDE3A and PDE3B as an inhibitor, and also binds cardiac troponin components TNNC1, TNNI3, and TNNT2. This dual mechanism combines phosphodiesterase inhibition with calcium sensitization of the cardiac contractile apparatus, supporting its development in cardiovascular and pulmonary hypertension indications.
Tenax Therapeutics, Inc. (ticker: TENX) is developing levosimendan under the designation TNX-103. The company is running Phase 3 clinical programs for the asset in pulmonary hypertension associated with HFpEF, with trials enrolling across the United States and multiple international sites.
Levosimendan (TNX-103) is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 program includes the LEVEL-2 trial and a long-term open-label extension study, with earlier Phase 2 work completed in PH-HFpEF patients.
Levosimendan (TNX-103) is being studied in several trials, including NCT07288398 (LEVEL-2, Phase 3, recruiting), NCT07436689 (Phase 3 long-term open-label extension, enrolling by invitation), NCT05983250 (Phase 3, active not recruiting), and the completed Phase 2 rollover study NCT03624010. Total enrollment across these studies is approximately 1,340 patients.
Yes, TNX-103 is the development designation used by Tenax Therapeutics for levosimendan. The two names refer to the same small molecule asset, so searches for either TNX-103 or levosimendan point to the same Phase 3 pulmonary hypertension program in PH-HFpEF.