Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Levosimendan · 3 trials · 8 indications
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 |
|---|---|---|
| Levosimendan | EXPERIMENTAL | levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours |
| Placebo | PLACEBO_COMPARATOR | placebo 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 |
|---|---|---|
| Levosimendan | DRUG | - |
| Placebo | DRUG | matching placebo |
| 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: * Documented LVEF ≤35% measured by ventriculogram, echocardiogram (ECHO), nuclear scan, or MRI within 60 days before surgery. * Scheduled or urgent 1) CABG surgery, 2)CABG with aortic valve surgery, 3) CABG with mitral valve surgery, or 4) mitral valve surgery with or without ot...
Levosimendan is an investigational small molecule being developed for cardiovascular conditions, including pulmonary hypertension secondary to heart failure with preserved ejection fraction (PH-HFpEF), coronary artery bypass grafting, and secondary pulmonary hypertension with heart failure. It is not approved and remains in clinical development.
Levosimendan is a calcium sensitizer that enhances cardiac contractility without increasing oxygen demand. It also opens ATP-sensitive potassium channels, leading to vasodilation. These effects are being studied for their potential benefit in heart failure and pulmonary hypertension.
Levosimendan is being developed by Tenax Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol TENX. The company is conducting clinical trials to evaluate the drug for cardiovascular indications.
Levosimendan is in Phase 3 clinical development for coronary artery bypass grafting, based on a completed Phase 3 trial. It has also completed Phase 2 trials for pulmonary hypertension secondary to heart failure with preserved ejection fraction. It remains investigational.
Levosimendan has completed three clinical trials. NCT02025621 was a Phase 3 study in 882 patients undergoing cardiac surgery. NCT03541603 and NCT03624010 were Phase 2 studies in patients with PH-HFpEF, enrolling 44 and 35 patients respectively.
Levosimendan is also known by the brand name Simdax in some markets. However, the clinical trials conducted by Tenax Therapeutics use the generic name Levosimendan. The drug is being investigated for cardiovascular indications including heart failure and pulmonary hypertension.