Na/K-ATPase inhibitors(Sodium/potassium-transporting ATPase inhibitors), SERCA2 activators(Sarcoplasmic/endoplasmic reticulum calcium ATPase 2 activators)

Therapeutic Areas

Cardiovascular DiseasesOther Diseases

Active Indication

ShockShock, Cardiogenic

Inactive Indication

Acute decompensated heart failureHeart Failure

Originator Organization

Sigma-Tau BV

Active Organization

Windtree Therapeutics, Inc.

Inactive Organization

Zhaoke Pharmaceutical (Hefei) Co., Ltd.

Sigma-Tau Industrie Farmaceutiche Riunite SpA

Debiopharm International SA

+ [1]

License Organization

Windtree Therapeutics, Inc.

ScinoPharm Taiwan Ltd.

Lee's Pharmaceutical Holdings Ltd.

+ [3]

Drug Highest PhasePhase 2

First Approval Date-

RegulationSpecial Review Project (China)

Structure/Sequence

Molecular FormulaC21H32N2O3

InChIKeyMPYLDWFDPHRTEG-IFVNMTGRSA-N

CAS Registry203737-93-3

Clinical Trials associated with Istaroxime

NCT05975021

/ Active, not recruitingPhase 1/2

A Multicenter, Randomized, Placebo-Controlled, Parallel Group Trial on the Safety and Efficacy of Istaroxime for Cardiogenic Shock SCAI Stage C

The current trial aims to assess the effect of istaroxime in patients with SCAI Stage C Cardiogenic Shock (CS). These patients look unwell, frequently with a sudden change in mental status, mottled and cool extremities, and delayed capillary refill, as well as signs of congestion and relative low blood pressure and signs of hypoperfusion (reduced oxygen to organs) which frequently require support with rescue therapies including inotropes, vasopressors, or mechanical devices.
Windtree Therapeutics, Inc. has been studying istaroxime, which has the potential to treat patients in this condition without some of the disadvantages of existing therapies being used to treat patients with acute heart failure and CS.
Participants enrolled in this trial will receive standard of care (SoC) therapy for heart failure and CS. Additionally, half of the participants will be randomly chosen to receive istaroxime. Istaroxime has the potential to increase blood pressure and improve cardiac function.

Start Date01 Jun 2024

Sponsor / Collaborator

Windtree Therapeutics, Inc.

NCT04325035

/ CompletedPhase 2

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study on the Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock (SEISMiC)

This is a pilot, multinational, randomized, double-blind, placebo-controlled, 2-part safety and efficacy study. Subjects will consist of patients hospitalized for acute decompensated heart failure with persistent hypotension.

Start Date28 Sep 2020

Sponsor / Collaborator

Windtree Therapeutics, Inc.

[+1]

NCT02617446

/ CompletedPhase 2

The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acute Decompensated Heart Failure - A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Clinical Study

To assess the safety, tolerability and efficacy of two different doses of istaroxime, a new agent with lusitropic and inotropic activities that improves the cardiac contraction-relaxation cycle. The 2 doses of istaroxime (0.5 and 1.0 µg/kg/min) will be infused via i. v. for 24 hours in comparison with placebo, in treatment of Chinese and Italian patients with Acute Decompensated Heart Failure.

Start Date01 Dec 2015

Sponsor / Collaborator

Windtree Therapeutics, Inc.

100 Clinical Results associated with Istaroxime

100 Translational Medicine associated with Istaroxime

100 Patents (Medical) associated with Istaroxime

101

Literatures (Medical) associated with Istaroxime

01 Feb 2026·EXPERT OPINION ON INVESTIGATIONAL DRUGS

Istaroxime – update of data in early cardiogenic shock and decompensated heart failure

Review

Author: Zimoch, Wojciech ; Biegus, Jan ; Florek, Kamila

INTRODUCTION:

Cardiogenic shock (CS) is the most severe manifestation of acute heart failure (AHF), which is associated with one-year mortality rates of up to 60%. Inotropes are a cornerstone of CS treatment, as they improve central hemodynamics and provide time to address the underlying etiology. Therefore, their early administration, before CS progresses to the neurohumoral and inflammatory phase, is of great importance. Currently used inotropes are associated with adverse events, including tachycardia, ischemia, hypotension, and arrhythmias, and novel medications with a safer and more effective profile are needed. One of promising medications is istaroxime, characterized by a lower risk of malignant arrhythmias and a unique ino-lusitropic mechanism of action.

AREAS COVERED:

This study aimed to describe the mechanism of action of istaroxime and present results from phase II clinical trials on its effectiveness and safety in patients with early CS.

EXPERT OPINION:

Phase II clinical trials demonstrated that istaroxime is effective in the management of early CS (hemodynamic effect). Its advantages stem from a favorable safety profile compared with traditional inotropes, along with proven efficacy in raising systolic blood pressure (SBP) and enhancing central hemodynamics. These effects are mediated through its unique ino-lusitropic mechanism, achieved without increasing heart rate.

01 Dec 2025·ESC Heart Failure

Haemodynamic Effects of Istaroxime in SCAI Stage B HF-Related Cardiogenic Shock: Insights from the SEISMiC Trial

Article

Author: Takagi, Koji ; Mebazaa, Alexander ; Filippatos, Gerasimos ; Pagnesi, Matteo ; Ponikowski, Piotr ; Zymliński, Robert ; Edwards, Christopher ; Diaz, Maria Luz ; Gulati, Gaurav ; Davison, Beth ; Novosadova, Maria ; Chioncel, Ovidiu ; Biegus, Jan ; Burkhoff, Daniel ; Guardia, Carlos ; Gajewski, Piotr ; Tycińska, Agnieszka ; Cotter, Gad ; Metra, Marco ; Simonson, Steven ; Barros, Marianela ; Simmons, Phillip

Abstract:

Aims:

The haemodynamic effects of istaroxime in SCAI stage B cardiogenic shock (CS) due to acute decompensated heart failure (ADHF) have not been evaluated. We assessed the impact of istaroxime on specific invasively-obtained haemodynamic measures.

Methods and results:

In the SEISMiC extension study, 30 patients with ADHF-related SCAI stage B CS were randomized to 60-h intravenous infusion of either placebo (n = 11) or istaroxime at maximum 0.5–1.0 μg/kg/min (n = 19). In this post hoc analysis, invasively-obtained haemodynamic measures, simulated group-averaged pressure-volume (PV) loops, and end-systolic elastance (Ees), derived from individual-patient PV relationships, were compared between istaroxime- and placebo-treated patients. Compared with placebo, patients randomized to istaroxime for 48–60 h had greater increases in aortic pulsatility index (API) and left ventricular (LV) stroke work index (LVSWI) at 6, 12, 24, and 48 h; and greater increase in pulmonary artery (PA) compliance and reduction in PA elastance at 48 h. At group-averaged PV loop analysis, LV contractility remained stable and right ventricular (RV) contractility tended to deteriorate over time with placebo, whereas LV contractility improved and RV contractility tended to be stabilized with istaroxime. Greater increases in both LV Ees and RV Ees were observed with istaroxime versus placebo from baseline to 48 h.

Conclusions:

In patients with ADHF-pre-CS, istaroxime at doses up to 1.0 μg/kg/min for up to 60 h was associated with sustained improvements in measures of LV performance (API and LVSWI), in parallel with increase in PA compliance and reduction in PA elastance at 48 h. As compared with placebo, istaroxime improved LV contractility and preserved RV contractility, which deteriorated on placebo, over time.

23 Sep 2025·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

How palytoxin transforms the Na ⁺ ,K ⁺ pump into a cation channel

Article

Author: Toyoshima, Chikashi ; Vilsen, Bente ; Cornelius, Flemming ; Tsunekawa, Naoki ; Kanai, Ryuta

Palytoxin (PTX), a potent marine toxin, has long been known to transform Na + ,K + -ATPase (NKA), an indispensable ion pump, into a nonselective cation channel. It has been postulated that PTX takes control of the two gates on either side of a channel-like pore. These gates normally open and close alternately, synchronized with chemical events, never opening simultaneously. A critical question is whether palytoxin takes over the control of the two gates or creates a new pathway. Here, we present structures of NKA with bound palytoxin in three different states. PTX binds to NKA in E2P, occupying the physiological Na + exit pathway, similar to istaroxime, a new-generation cardiotonic steroid. Adding Na + and ATP/ADP to the NKA·PTX complex induces an open channel traversing the entire membrane alongside the physiological ion pathway. As AlF x , a stable transition state analog of phosphate replaces phosphate in the NKA·PTX complex preformed in E2P, the complex appears to undergo the normal reaction cycle from E2P to E1· n Na + . PTX occupies the space between the transmembrane helices M4 and M6, thereby preventing the closure of the extracellular half of the ion pathway. These structures demonstrate that the architecture of NKA is fundamentally different from “a pore with two gates.” Each half of the ion pathway comprises three segments, including a movable component that plays a pivotal role in translocating the bound cations by connecting the constant part to an appropriate inlet. The ion pathway of NKA transforms dynamically, ensuring that the two halves never exist simultaneously.

News (Medical) associated with Istaroxime

30 Mar 2026

·www.prnewswire.com

Panacea Capital Leads Formation of Seismic Pharma to Advance Novel, Clinical-Stage Heart Failure Portfolio

New company formed to unlock value from Phase 3-ready and next-generation therapies for cardiogenic shock and acute heart failure Targeting completion of first Phase 3 study for istaroxime to enable NMPA registration by 2027 Advancing next-generation oral heart failure program towards first-in-human studies by 2027 DURHAM, N.C. and SINGAPORE, March 30, 2026 /PRNewswire/ -- Seismic Pharma, a newly formed biopharmaceutical company, today announced its launch and initial financing led by Panacea Capital. The company has been formed to advance a portfolio of clinically validated and next-generation drug candidates for the treatment of heart failure acquired from Windtree Therapeutics. Seismic Pharma's lead program, istaroxime, is a Phase 3-ready, first-generation calcitrope for cardiogenic shock with extensive clinical data demonstrating its ability to improve hemodynamic stability and cardiac function, without the safety limitations associated with conventional inotropic therapies. Together with next-generation compounds targeting acute and advanced heart failure, the company's portfolio is aimed at addressing critical gaps in patient care across both inpatient and outpatient settings. "With no approved therapeutics, cardiogenic shock is the last major frontier in treating heart failure. More broadly, acute heart failure and advanced heart failure remain some of the most significant unmet needs in cardiovascular medicine, yet no medications have been approved for these conditions in decades. We believe our portfolio represents a compelling opportunity to deliver meaningful new options for patients," said Gad Cotter, MD. "At Panacea Capital, we build companies around high-conviction therapeutic assets, and Seismic Pharma represents a clear opportunity to do exactly that," said James Huang, Founder and Managing Partner of Panacea Capital. "Gad and the team bring deep domain expertise and a track record of translating clinical insight into successful development programs and strategic exits. We are excited to partner closely with them to advance Seismic's portfolio efficiently toward key clinical milestones." About Seismic Pharma Seismic Pharma is a biopharmaceutical company dedicated to advancing novel treatments for heart failure. The company combines deep therapeutic expertise with a proven track record in acute heart failure drug development. Seismic Pharma's founding portfolio of drug candidates was acquired from Windtree Pharmaceuticals and will be advanced toward clinical development with the support of a board of directors with extensive experience in successful heart failure programs. The company is headquartered in Durham, North Carolina About Panacea Capital Panacea Capital is a global life sciences investment firm that builds and scales innovative companies across therapeutic and adjacent healthcare opportunities, unified by an asset-centric and execution-driven approach. The firm invests across private and public markets and works closely with management teams to shape strategy, structure capital, and drive execution from early development through commercialization. With deep experience in drug development and cross-border execution, Panacea Capital operates seamlessly across the U.S. and Asia to accelerate development timelines, enhance capital efficiency, and expand access to regulatory and commercial opportunities. Contact: Gad Cotter, Seismic Pharma – [email protected] SOURCE Seismic Pharmaceuticals 21% more press release views with Request a Demo

Phase 3

04 Sep 2025

·www.prnewswire.com

Late Breaking Clinical Research Coming to Heart Failure Society of America Annual Scientific Meeting September 26-29

WASHINGTON, Sept. 4, 2025 /PRNewswire/ -- The Heart Failure Society of America (HFSA) is pleased to announce the Late Breaking Clinical Research that will be presented at its Annual Scientific Meeting (ASM), September 26-29, at the at the Minneapolis Convention Center in Minneapolis, MN. Late breaking clinical research to be featured during two plenary sessions includes results and updates from these major randomized trials: Continue Reading Heart Failure Society of America Annual Scientific Meeting 2025 takes place September 26-29 in Minneapolis, MN. Sunday, September 28 Plenary Session | 9:00 AM – 10:30 AM Late Breaking Clinical Research 1: Devices and Cardiomyopathies Integra-D Trial Effects of a Novel Cardiac Contractility Modulation-Defibrillator (CCM-D) on NYHA Functional Class in ICD-Indicated Patients: Post-Implant Results from the Integra-D Trial FUTURE-HF Development of an Individualized Congestion Score using a Novel Implantable Inferior Vena Cava Sensor: the FUTURE-HF Trial Portfolio DETECT-HF Development and Training of a Voice-Based Algorithm for Heart Failure Monitoring: Performance results from 599 Patients over 360,000 Patient-Days FOREST-HCM Safety and Efficacy of Aficamten in Patients with Nonobstructive Hypertrophic Cardiomyopathy: a 96-week analysis from FOREST-HCM MAPLE-HCM Divergent Effect of Aficamten Versus Metoprolol on Exercise Performance in Obstructive Hypertrophic Cardiomyopathy: A Prespecified Analysis of MAPLE-HCM ATTRibute-CM Acoramidis Reduces Cumulative Cardiovascular Outcomes Within the First Month of Treatment in Transthyretin Amyloid Cardiomyopathy: Results From ATTRibute-CM HELIOS-B Reduction in Gastrointestinal Events in ATTR-CM Patients Treated with Vutrisiran Compared with Placebo: Analysis from HELIOS-B Monday, September 29 Plenary Session | 9:00 AM – 10:30 AM Late Breaking Clinical Research 2: Novel Therapies VICTOR Trial Vericiguat Efficacy and Safety Across Baseline Background Therapy in Contemporary Ambulatory Patients with HFrEF Enrolled in the VICTOR trial Tolerability and Safety of Vericiguat in Chronic Heart Failure with Reduced Ejection Fraction SEISMiC C Safety and Efficacy of Intravenous Administration of Istaroxime for 48 hours in Patients with SCAI C Cardiogenic Shock due to Acute Heart Failure SUMMIT Trial Effects of Tirzepatide in Obesity-Related HFpEF by Sex: A Prespecified Secondary Analysis from the SUMMIT Trial GARDEN TIMI-74 GDF-15 Neutralization in Patients with Heart Failure: Primary Results of the GARDEN-TIMI 74 Trial Danicamtiv Trial Danicamtiv Restores Ventricular and Atrial Function in Patients with Dilated Cardiomyopathy Caused by Genetic Variants that Depress Sarcomere Function Late Breaking Clinical Research showcases novel results of major randomized trials and rapidly evolving research. Due to the quantity of remarkable trials submitted, HFSA will also feature late breaking research through Rapid Fire Oral Sessions. These Rapid Fire sessions are fast-paced oral presentations spotlighting key data from late breaking clinical research. Sessions take place on Sunday and Monday with Q&A and new topics each day. Sunday September 28 | Rapid Fire 1 | 10:45 AM - 11:45 AM Phase 1 Study of Daratumumab-Hyaluronidase for Reduction of Circulating Antibodies in Patients with High Allosensitization Awaiting Heart Transplantation Safety of Sodium-Glucose Cotransporter 2 Inhibitors in Post-Heart Transplant Patients: A Multi-Center Retrospective Cohort Study Long Term Outcomes after LVAD Weaning for Myocardial Recovery: Results from the VAD Wean Recovery Network First-In-Human Implantation of a Next-Generation Membrane-Based LVAD Long Term Trajectory of Glomerular Filtration Rate Post-LAVD and the Impact on Clinical Outcomes: An analysis of the MOMEMTUM 3 Study Increased LVEF at Six Months Following LVAD Implant is Associated with Improved Long-Term Outcomes - A MOMENTUM-3 Analysis Screening for advanced heart failure in stable outpatients (The SAINTS study) Sunday, September 28 | Rapid Fire 2: | 2:15 PM - 3:15 PM Clinical Outcomes for Heart Failure at High Risk of Hyperkalemia according to Optimization of Agents Targeting the Renin-Angiotensin-Aldosterone System Intravenous Ferric Carboxymaltose in Patients With Ischemic Versus Non-Ischemic Etiology of Heart Failure and Iron Deficiency Residual Risk of Hyperkalemia Among Patients with Heart Failure Treated with SGLT2i and ARNI Instead of ACEI/ARB High-Dose IV Loop Diuretic Therapy and Ototoxicity Risk in Patients with Acute Heart Failure: Insights from the FASTR Trial Expanded Results from a Guideline-Directed Medical Therapy Clinic Optimized Heart Failure Therapy in Patients at Risk of Cardiac Wasting in Patients with Advanced Cancer: Results from the EMPATICC trial Supervised Exercise Training Improves Outcomes in Heart Failure: Evidence from the PACT-HF 2×2 Factorial Trial Sunday, September 28 | Rapid Fire 3 | 4:15 PM - 5:15 PM Cardiac Contractility Modulation Reduces Mortality and Heart Failure Hospitalizations: A Matched Comparison of Patients Receiving and Not Receiving CCM Derived from a Real-World Dataset PROACTIVE-HF: 2-year outcomes, stratified by LVEF Outcomes of Poor Clinical Responders After Transcatheter Aortic Valve Replacement in Older Patients Invasive Hemodynamic Risk Stratification and Transcatheter Edge-to-Edge Tricuspid Repair: One-Year Results from TRILUMINATE Pivotal Trial Relationship between changes in seated pulmonary artery pressure, blood pressure, heart rate, and weight prior to heart failure hospitalization A Randomized Trial of a Remote, Digital Intervention Targeting Heart Failure Medical Therapy Machine-Learning Estimation of Pulmonary Capillary Wedge and Right Atrial Pressures With a Non-invasive Multisensor Device Deep learning assisted prediction for occurrence of pacing-induced cardiomyopathy in the atrio-ventricular block Monday, September 29 | Rapid Fire 4 | 12:00 PM – 1:00 PM Effect of vericiguat, compared with placebo, across baseline risk categories in chronic heart failure with reduced ejection fraction in the VICTOR Trial Effect of Vericiguat on Heart Failure Hospitalisation Events in Ambulatory Patients with Heart Failure and Reduced Ejection Fraction: VICTOR Trial Prespecified Analysis Effect of Vericiguat on Mortality in Ambulatory Patients with Heart Failure and Reduced Ejection Fraction: VICTOR Trial Prespecified Analysis Regional Variation in Outcomes and Response to Vericiguat in Heart Failure with Reduced Ejection Fraction: The VICTOR Trial Effect of the Soluble Guanylate Cyclase Stimulator Vericiguat on Health Status in the Phase 3 VICTOR Trial The Effect of Vericiguat on Mode of Death in Patients with Heart Failure with Reduced Ejection Fraction in the VICTOR Trial Rapidity of benefit of simultaneous initiation of finerenone and empagliflozin in people with chronic kidney disease and type 2 diabetes: the CONFIDENCE trial Dapagliflozin in Patients with Heart Failure: A Meta-Analysis of DAPA-HF, DELIVER, and DAPA ACT HF-TIMI 68 The meeting kicks off in just three weeks. A full schedule at a glance is available online, as well as information on the science and research and networking available at the meeting. Learn more about the meeting and register at hfsa.org/asm2025. About the Heart Failure Society of America The Heart Failure Society of America, Inc. (HFSA) represents the first organized effort by heart failure experts from the Americas to provide a forum for all those interested in heart function, heart failure, and congestive heart failure (CHF) research and patient care. The mission of HFSA is to provide a platform to improve and expand heart failure care through collaboration, education, innovation, research, and advocacy. HFSA members include physicians, scientists, nurses, nurse practitioners, pharmacists, trainees, other healthcare workers and patients. For more information, visit hfsa.org. Media Contact: Laura Poko, 301-798-4493, ext. 226, [email protected] SOURCE Heart Failure Society of America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Phase 1

11 Aug 2025

·www.globenewswire.com

Windtree Announces Istaroxime has been Chosen for a Plenary Session Presentation at the Heart Failure Society of America 2025

Presentation will be the interim data from the Phase 2 study of istaroxime in SEISMiC C - Cardiogenic Shock SCAI Stage C Cardiogenic shock SCAI Stage C has an in hospital mortality rate of 20-30% Istaroxime interim data was consistent with the profile seen in previous studies gives Windtree confidence to move forward with a global Phase 3 study WARRINGTON, Pa., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners, announced that istaroxime was chosen for a presentation entitled, “Safety and Efficacy of intravenous administration of istaroxime for 48 hours in patients with SCAI Stage C cardiogenic shock due to heart failure” at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025. Acute decompensated heart failure and cardiogenic shock have had very little drug innovation in decades. The Company believes istaroxime has a profile that offers potential benefits to patients with low blood pressure due to heart failure. Istaroxime improves cardiac function and can increase blood pressure without increasing heart rate. Also, istaroxime tends to preserve measures of renal function and contributes to resolution of congestion and fluid overload that often accompanies heart failure. Importantly, it does not appear to increase clinically significant arrythmias. The istaroxime cardiogenic shock SCAI Stage C interim analysis included the first 20 patients enrolled in the study. There were no new safety concerns identified, and no apparent excess arrythmias in patients treated with istaroxime when given with standard of care therapies. The effects on hemodynamic and echocardiographic measures appeared to be consistent with results seen in previous istaroxime studies. “We are very pleased with the interim results of the SEISMiC C study,” said Jed Latkin, Chief Executive Officer of Windtree. “We believe istaroxime can be an important drug innovation for acute decompensated heart failure and cardiogenic shock patients because the istaroxime studies have promising results and this is a condition with a large unmet need and has been underserved for decades.” About IstaroximeIstaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously can significantly improve cardiac function and blood pressure without increasing heart rate or the incidence of clinically significant cardiac rhythm disturbances. About Windtree Therapeutics, Inc.Windtree Therapeutics, Inc. is a diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners. Forward Looking StatementsThe Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include, among other things: the success of the SEISMiC C Study, the ability to move istaroxime to a global Phase 3 program and risks related to the Company’s ability to manage costs and execute on its operational and budget plans. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events, or otherwise, after the date of this press release. Contact Information:Eric Curtisecurtis@windtreetx.com

Phase 2Phase 3AHA

100 Deals associated with Istaroxime

External Link

KEGG	Wiki	ATC	Drug Bank
-	Istaroxime	-	DB06157

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Shock	Phase 2	United States	Windtree Therapeutics, Inc.	28 Sep 2020
Shock	Phase 2	Argentina	Windtree Therapeutics, Inc.	28 Sep 2020
Shock	Phase 2	Italy	Windtree Therapeutics, Inc.	28 Sep 2020
Shock	Phase 2	Poland	Windtree Therapeutics, Inc.	28 Sep 2020
Shock, Cardiogenic	Phase 2	United States	Windtree Therapeutics, Inc.	28 Sep 2020
Shock, Cardiogenic	Phase 2	Argentina	Windtree Therapeutics, Inc.	28 Sep 2020
Shock, Cardiogenic	Phase 2	Italy	Windtree Therapeutics, Inc.	28 Sep 2020
Shock, Cardiogenic	Phase 2	Poland	Windtree Therapeutics, Inc.	28 Sep 2020
Acute decompensated heart failure	Phase 2	-	Debiopharm International SA	01 Jun 2009
Heart Failure	Phase 2	-	-	01 Aug 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04325035 (SEISMiC, GlobeNewswire) Manual	Phase 2	Shock, Cardiogenic	20	Istaroxime	cbvblzaufe(pdmpfbdcla) = There were no new safety concerns identified, and no apparent excess arrhythmias in patients treated with istaroxime when given with standard of care therapies. The effects on hemodynamic and echocardiographic measures appeared to be consistent with results seen in previous istaroxime studies. aqraqnvywa (pmwnvvdfte )	Positive	05 Aug 2025
				Placebo
NCT04325035 (SEISMiC, GlobeNewswire) Manual	Phase 2	Heart Failure	30	Istaroxime	ieadpatdjt(mcrtfxuije) = kpvgozvsxf pfvgsvltpv (yhwxwddaqr ) View more	Positive	30 Sep 2024
				Placebo	ieadpatdjt(mcrtfxuije) = oixrturcnn pfvgsvltpv (yhwxwddaqr ) View more
NCT02617446 (CTgov)	Phase 2	Acute decompensated heart failure	120	Istaroxime (Istaroxime 0.5 µg/kg/Min)	bylrigyepx(vicbnjoodj) = tooabgmzay ujnpgcudyo (xvhqujnuys, kjumnygdtd - rssebthhue) View more	-	24 May 2023
				Istaroxime (Istaroxime 1.0 µg/kg/Min)	bylrigyepx(vicbnjoodj) = rrnjzzvcpi ujnpgcudyo (xvhqujnuys, ojegxulkzg - nkloolzhft) View more
NCT02772068 (Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a, Pubmed \| JACC Heart Fail)	Early Phase 1	Heart failure with normal ejection fraction	26	Istaroxime 0.5 mg/kg/min	lptjakypos(zlytihyklh) = qerecrjxig wnhtdtewgr (tnrzcjrxhm ) View more	-	15 Mar 2023
				Placebo	lptjakypos(zlytihyklh) = goltnnflia wnhtdtewgr (tnrzcjrxhm ) View more
SEISMiC (Pubmed \| Eur J Heart Fail)	Phase 2	-	-	Istaroxime 1.0-1.5 μg/kg/min	hnraqyxpgl(vxfeyusjwd) = uxfqxxmwgx rorcurjsbo (rllavurmvv, 6.88) View more	Positive	01 Oct 2022
				Placebo	hnraqyxpgl(vxfeyusjwd) = yyksusbpqx rorcurjsbo (rllavurmvv, 6.76)
NCT04325035 (SEISMiC, Pubmed) Manual	Phase 2	Heart Failure \| Shock	60	istaroxime	uybdwtxuto(wvrlvneegd) = hyxenvvcco anowptdapc (inqfpnznti, 6.88) View more	Positive	22 Jul 2022
				Placebo	uybdwtxuto(wvrlvneegd) = ytixksecek anowptdapc (inqfpnznti, 6.76) View more
NCT04325035 (SEISMiC, Biospace) Manual	Phase 2	Heart Failure \| Shock, Cardiogenic	60	Istaroxime	tbpvslppoo(xhehlyrasq): P-Value = 0.017 View more	Positive	23 May 2022
				Placebo
NCT00616161 (HORIZON-HF, Pubmed \| J Am Coll Cardiol)	Phase 2	Heart Failure	120	Istaroxime	axjkrpqtec(pyvlgylipo) = iuurexqhnj jrnxtrknbp (lbvjpiuzbo )	-	10 Jun 2008

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