Istaroxime is under clinical development by Windtree Therapeutics and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Istaroxime’s likelihood of approval (LoA) and phase transition for Acute Heart Failure took place on 06 Jun 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Istaroxime Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Istaroxime overview

Istaroxime (Debio-0614, PST-2744) is under development for the acute decompensated heart failure and early cardiogenic shock. The drug candidate is administered as intravenous infusion. Istaroxime targets sodium-potassium adenosine triphosphatase (ATPase) with the property of increasing sarcoplasmic reticulum calcium ATPase (SERCA) isoform 2a (SERCA2a) activity.

Windtree Therapeutics overview

Windtree Therapeutics is a biopharmaceutical company that focuses on developing its drug product candidates for the treatment of pulmonary and cardiovascular diseases. The company’s lead development programs are istaroxime, for treating acute decompensated heart failure (ADHF) and cardiogenic shock; Aerosurf, a lucinactant for inhalation, and lyophilized KL4 surfactant intratracheal suspension, both for treating respiratory distress syndrome (RDS) in premature infants; KL4 surfactant for the treatment of lung injury effected by sever Covid-19 infection; oral SERCA2a activators for chronic heart failure; Eleison Oncology for ADS; CVI-IST2 for oral heart failure and rostafuroxin for treating genetically associated hypertension. The company benefits from proprietary technology platform Aerosol Delivery System (ADS) with pulmonary surfactants or in combination with other products to treat pediatric and adult respiratory disorders. The company operates in Taiwan, Milan, Taipei, and Italy. Windtree Therapeutics is headquartered in Warrington, Pennsylvania, the US.

Quick View Istaroxime LOA Data

Report Segments
  • Innovator
Drug Name
  • Istaroxime
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Cardiovascular
Key Developers
Highest Development Stage
  • Phase II

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.