Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PST2744
Istaroxime · 3 trials · 2 indications
Change from baseline AUC for systolic blood pressure
Change from baseline at 24 hours in the unitless ratio of E (cm/sec) to Ea (or e') (cm/sec) as measured by echocardiogram. The endpoint is the Tissue Doppler echocardiography showing measurement of mitral E/Ea ratio for assessment of diastolic dysfunction. Initially mitral E wave is measured. After that, color Tissue Doppler (tissue velocity imaging or TVI) mode is switched on to assess tissue Doppler. The cursor is placed over the medial mitral annulus and tissue Doppler tracing obtained. This allows Ea velocity to be measured. Higher values are suggestive of a worse outcome; less than 8 is normal.
Systolic blood pressure (SBP) area under the curve (AUC) from start of infusion to 6 hours
| Arm | Type | Description |
|---|---|---|
| Istaroxime - Part A | EXPERIMENTAL | Istaroxime IV infusion for 24 hours. Istaroxime administration can begin at 1.0 or 1.5 µg/kg/min; the target infusion rate is 1.5 µg/kg/min |
| Placebo - Part A | PLACEBO_COMPARATOR | Placebo (lactose lyophilized powder) IV infusion for 24 hours |
| Istaroxime - Part B | EXPERIMENTAL | Istaroxime IV infusion at 1.0 µg/kg/min for 6 hours, 0.5 µg/kg/min for 42 hours, 0.25 µg/kg/min for 12 hours. |
| Istaroxime and Placebo - Part B | EXPERIMENTAL | Istaroxime IV infusion at 0.5 µg/kg/min for 48 hours, followed by placebo IV infusion for 12 hours. |
| Placebo - Part B | PLACEBO_COMPARATOR | Placebo (lactose lyophilized powder) IV infusion for 60 hours. |
| Placebo | PLACEBO_COMPARATOR | IV infusion of placebo for 24 hours |
| Istaroxime 0.5 µg/kg/min | EXPERIMENTAL | The istaroxime treatment dosed at 0.5 µg/kg/min via IV infusion for 24 hours |
| Istaroxime 1.0 µg/kg/min | EXPERIMENTAL | The istaroxime treatment dosed at 1.0 µg/kg/min via IV infusion for 24 hours |
| Istaroxime | EXPERIMENTAL | Istaroxime delivered as an IV infusion via a syringe pump. Dosage regime is 1.0 µg/kg/min for 6 hours, 0.5 µg/kg/min for 42 hours. Total duration 48 hours. |
| Name | Type | Description |
|---|---|---|
| Istaroxime | DRUG | Reconstituted istaroxime and lactose lyophilized powder delivered via IV infusion |
| Placebo | DRUG | Reconstituted placebo (lactose lyophilized powder) delivered via IV infusion |
Inclusion Criteria: 1. Clinical presentation consistent with SCAI Stage B pre-cardiogenic shock caused by acute decompensation of chronic systolic heart failure (due to arterial hypertension, ischemic heart disease or dilated cardiomyopathy), without evidence for an acute coronary syndrome. 2. Sign...
Istaroxime is an investigational small molecule being developed for acute decompensated heart failure and cardiogenic shock. It is not approved for any indication and remains in clinical development. Windtree Therapeutics is studying it in hospitalized patients with these acute cardiovascular conditions, including a Phase 2 program in pre-cardiogenic shock and a Phase 1 trial in Stage C cardiogenic shock.
Istaroxime targets ATP2A2, also known as SERCA2a, along with the sodium-potassium ATPase subunits ATP1A1, ATP1A2, ATP1B1, ATP1B2, and ATP1B3. It acts as an activator of these targets. By targeting ATP2A2 and the sodium-potassium ATPase, istaroxime is designed to influence cardiac muscle relaxation and contraction in heart failure and cardiogenic shock.
Istaroxime is being developed by Windtree Therapeutics, Inc., which trades under the ticker WINT. The company is advancing the small molecule through clinical trials in acute decompensated heart failure and cardiogenic shock.
Istaroxime is in Phase 2 development. It is an investigational drug and has not been approved by the FDA. Windtree Therapeutics has completed a Phase 2 trial in pre-cardiogenic shock and a Phase 2 trial in acute decompensated heart failure, and has an active Phase 1 trial in Stage C cardiogenic shock.
Istaroxime has been studied in three clinical trials. NCT05975021 is an active Phase 1 safety and efficacy trial in Stage C cardiogenic shock. NCT04325035 is a completed Phase 2 trial in pre-cardiogenic shock, and NCT02617446 is a completed Phase 2 trial in acute decompensated heart failure. These trials enrolled patients in the United States, Argentina, Israel, Italy, Poland, and China.