company OVERVIEW


Windtree Therapeutics is advancing multiple late-stage interventions for acute cardiovascular and pulmonary syndromes to support patients in their moments of crisis. Windtree’s goal is to develop unique therapies that significantly improve upon the treatment of severe, acute conditions, such as heart failure, early cardiogenic shock, lung injury associated with COVID-19 and neonatal respiratory distress – addressing some of the most underserved and costly acute conditions.

The Company’s lead clinical programs include:

Istaroxime represents a novel approach to the treatment of AHF. It has a dual mechanism of action to improve cardiovascular physiology. Current therapy for heart failure in the hospital typically includes intravenous diuretics and, if the blood pressure is low, supportive therapy with inotropes. Inotropes are often associated with adverse effects such as hypotension, arrhythmias and, in some cases, increased mortality. These drugs are used only if needed to support blood pressure and cardiac function. We believe that istaroxime, if approved, may have the potential to address unmet medical needs of these patients by improving cardiac function and management of fluid accumulation that contributes to heart failure symptoms with a potentially differentiated safety profile from current AHF therapies, including a potential reduction in complications and improvement of other clinical outcomes. There are more than 1.3 million hospital admissions for heart failure in the U.S. each year and over 2.5 million hospital estimated admissions for AHF in the combined U.S., EU, and Japan markets. Istaroxime has received a Fast Track designation by the U.S. FDA for acute heart failure. Given the observed significant improvements to blood pressure in those studies, istaroxime is also being studied in AHF patients in crisis suffering from early cardiogenic shock due to severe heart failure. We believe positive data in early cardiogenic shock could lead to an opportunity for a Breakthrough Therapy designation by the FDA, which may provide for an expedited development program. Read more…

Lucinactant (KL4 Surfactant)
Windtree’s KL4 surfactant is a synthetic surfactant that is structurally similar to human pulmonary surfactant. Surfactant is the substance in our lungs that prevents the lungs from collapsing when exhaling and improves oxygen transfer to the blood when inhaling. Read more…

AEROSURF® is drug-device combination that incorporates our synthetic KL4 surfactant designed to treat premature infants suffering from respiratory distress syndrome, a common complication with preterm births resulting from inadequate surfactant production. AEROSURF allows the health care professional to non-invasively deliver surfactant using Windtree’s proprietary Aerosol Delivery System (ADS) in order to avoid complications frequently associated with traditional, invasive administration of an animal-derived surfactant via intubation and mechanical ventilation. Data from Phase 2 trials have demonstrated that AEROSURF has the potential to improve lung function and reduce the need for intubation and mechanical ventilation in premature infants with RDS.. AEROSURF has a Fast Track designation by the U.S. FDA for RDS development as well as Orphan designations in the U.S. and EU. Read more…

To learn more about Windtree’s clinical and pre-clinical programs, including efforts in acute respiratory injury see our Pipeline & Therapeutic Overview page for more details.

Windtree is headquartered in Warrington, PA with operations in Taiwan and Milan, Italy.