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Levosimendan · 2 trials · 2 indications
| Name | Type | Description |
|---|---|---|
| levosimendan | DRUG | - |
| dobutamine | DRUG | - |
Inclusion Criteria: * Written, signed and dated informed consent * Male and female patients over 18 years of age. Females of childbearing potential must have a negative pregnancy test and must refrain from breastfeeding. Women who are postmenopausal \[two years since last menstrual cycle\], surgica...
Levosimendan is being developed for the treatment of acute heart failure and decompensated congestive heart failure. It is intended for patients who need intravenous inotropic support, meaning it is studied in hospitalized patients whose hearts are not pumping strongly enough. It is a small molecule therapeutic in the cardiovascular area.
Levosimendan targets PDE3A and PDE3B, which are phosphodiesterase enzymes, and also binds the cardiac troponin proteins TNNC1, TNNI3 and TNNT2. It acts as an inhibitor at these targets. This combination of phosphodiesterase inhibition and troponin binding underlies its activity as an intravenous inotropic agent in heart failure.
Levosimendan is being developed by Abbott Laboratories, which trades under the ticker ABT. Abbott is the company associated with the clinical development program for this small molecule cardiovascular asset.
Levosimendan is in Phase 3 clinical development. It is an investigational agent and is not described as approved. The Phase 3 program includes completed randomized, double-blind trials in acute heart failure and decompensated chronic heart failure, with enrollment of 1,300 and 600 patients respectively.
Levosimendan has been studied in completed Phase 3 trials. NCT00348504 compared intravenous levosimendan with dobutamine in 1,300 patients with acute heart failure requiring inotropic support, and NCT00048425 evaluated intravenous levosimendan in 600 patients with decompensated chronic heart failure. Both trials enrolled adults aged 18 years and older.
Levosimendan is also known by the brand name Simdax. Searches for Simdax refer to the same small molecule developed by Abbott Laboratories for acute heart failure and decompensated congestive heart failure. The two names describe one investigational cardiovascular drug in Phase 3 development.