Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Istaroxime · 4 trials · 3 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
safety of istaroxime in healthy volunteers is measured by
| 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. |
| low dose group | EXPERIMENTAL | 8 subjects in 0.25ug/kg/min group were administrated Istaroxime + 0.9% NS; All the subjects were given infusion of study drugs for 24 hours, and then were observed for 48 hours in the clinic. |
| mid dose group | EXPERIMENTAL | 12 subjects in 0.5ug/kg/min group randomly received Istaroxime placebo + 0.9% NS (2 subjects), 0.9% NS alone (2 subjects) and Istaroxime + 0.9% NS (8 subjects). All the subjects were given infusion of study drugs for 24 hours, and then were observed for 48 hours in the clinic. |
| high dose group | EXPERIMENTAL | 12 subjects in 1.0 ug/kg/min group randomly received Istaroxime placebo + 0.9% NS (2 subjects), 0.9% NS alone (2 subjects) and Istaroxime + 0.9% NS (8 subjects). All the subjects were given infusion of study drugs for 24 hours, and then were observed for 48 hours in the clinic. |
| 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 |
| 9% Saline (NS) | DRUG | infusion for 24 hours |
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 cardiovascular conditions, specifically cardiogenic shock and acute decompensated heart failure. It has also been studied in healthy volunteers. The drug is currently in Phase 2 clinical development and is not approved by the FDA.
Istaroxime is being developed by Windtree Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol WINT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with cardiogenic shock and acute decompensated heart failure.
Istaroxime is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials in acute decompensated heart failure and cardiogenic shock, and an additional Phase 1 trial for cardiogenic shock is active but not recruiting. The drug remains investigational and has not received FDA approval.
Istaroxime has been studied in several clinical trials. NCT02477449 was a completed Phase 1 trial in healthy volunteers in China. NCT02617446 was a completed Phase 2 trial for acute decompensated heart failure in China and Italy. NCT04325035 was a completed Phase 2 trial for pre-cardiogenic shock. NCT05975021 is an active Phase 1 trial for cardiogenic shock Stage C.
Istaroxime is a distinct investigational small molecule developed by Windtree Therapeutics. It is not known to be the same as any other marketed drug. Its mechanism of action has not been publicly detailed in the available clinical trial information.