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WINDTREE THERAPEUTICS, INC. (WINT)

SymbolWINT
NameWINDTREE THERAPEUTICS, INC.
SectorHEALTH CARE
RegionNorth America
Industry-
Address18976 United States PA 2600 Kelly Road Suite 100
Telephone(215) 488-9300
Fax—
Email—
Websitehttp://www.windtreetx.com
IncorporationUS
Incorporated On1992
Employees—
Fiscal Year12/31
Public Since—
ExchangesOTC;NASDAQ;OTCID
AuditorErnst & Young LLP;
Audit StatusAUDITED
Reporting StatusU.S. Reporting: SEC Reporting
CIK0000946486
Description

A clinical-stage biopharmaceutical and device company focused on developing novel therapies for acute cardiovascular and pulmonary diseases. Windtrees lead product candidates are being developed to treat acute heart failure and respiratory distress syndrome in premature infants.

Additional info from NASDAQ:
Windtree Therapeutics Inc is a development-stage biotechnology company focused on developing KL4 surfactant therapies for respiratory diseases. Its technology platform includes synthetic, peptide-containing surfactant and novel drug delivery technologies that deliver aerosolized KL4 surfactants without invasive procedures. Its development program utilizing its proprietary technology platform is AEROSURF which is being developed for the treatment of respiratory distress syndrome in premature infants. It operates in the business segment of research and development of products focused on surfactant therapies for respiratory disorders and diseases, and the manufacture and commercial sales of approved products.

Additional info from OTC:
A clinical-stage biopharmaceutical and device company focused on developing novel therapies for acute cardiovascular and pulmonary diseases. Windtrees lead product candidates are being developed to treat acute heart failure and respiratory distress syndrome in premature infants.

Additional info from OTCID:
A clinical-stage biopharmaceutical and device company focused on developing novel therapies for acute cardiovascular and pulmonary diseases. Windtrees lead product candidates are being developed to treat acute heart failure and respiratory distress syndrome in premature infants.

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Trial ID Title Phase Indication Status Start Date Completion Date Source
NCT05975021 A Safety and Efficacy Trial of Istaroxime for Cardiogenic Shock Stage C Phase1 Cardiogenic Shock Active_Not_Recruiting 2024-06-01 2026-08-31 ClinicalTrials.gov
NCT04706962 TH1902 in Patients With Advanced Solid Tumors Phase1 Solid Tumor Active_Not_Recruiting 2021-03-04 2026-01-01 ClinicalTrials.gov
NCT04389671 The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults Wi… Phase2 COVID-19 Completed 2021-01-05 2022-02-20 ClinicalTrials.gov
NCT04325035 The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock Phase2 Cardiogenic Shock Completed 2020-09-28 2024-10-30 ClinicalTrials.gov
NCT04264156 A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 2… Phase2 Respiratory Distress Syndrome, Newborn Terminated 2020-04-18 2021-03-28 ClinicalTrials.gov
NCT02617446 The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acu… Phase2 Acute Decompensated Heart Failure Completed 2015-12-01 2019-02-06 ClinicalTrials.gov
NCT03217825 Antihypertensive Effect of Different Doses of Rostafuroxin in Comparison With L… Phase2 Hypertension Completed 2015-12-01 2018-02-08 ClinicalTrials.gov
NCT02636868 The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 … Phase2 Respiratory Distress Syndrome Completed 2015-12-01 2019-08-06 ClinicalTrials.gov
NCT02528318 Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Pr… Phase2 Respiratory Distress Syndrome Terminated 2015-08-01 2017-08-11 ClinicalTrials.gov
NCT02074059 Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Pr… Phase2 Respiratory Distress Syndrome Completed 2014-02-01 2015-11-01 ClinicalTrials.gov
NCT00934362 Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease Phase2 Cystic Fibrosis Completed 2008-10-01 2010-08-01 ClinicalTrials.gov
NCT00578734 Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up… Phase2 Acute Hypoxemic Respiratory Failure Completed 2007-06-01 2010-04-01 ClinicalTrials.gov
NCT00295230 Effects of Volume Guarantee With Pressure Supported vs. Synchronized Intermitte… — Respiratory Distress Syndrome Suspended 2006-02-01 2007-09-01 ClinicalTrials.gov
NCT00215540 SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very … Phase2 Respiratory Distress Syndrome, Newborn Terminated 2005-02-01 2006-07-01 ClinicalTrials.gov
NCT00807235 Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Dist… Phase2 Respiratory Distress Syndrome Terminated 2005-01-01 2005-09-01 ClinicalTrials.gov
NCT00215553 KL₄Surfactant Treatment in Patients With ARDS Phase2 Acute Respiratory Distress Syndrome Terminated 2001-05-01 2006-02-01 ClinicalTrials.gov
NCT00004500 Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Mec… Phase3 Meconium Aspiration Terminated 2000-03-01 2004-11-01 ClinicalTrials.gov
Total clinical trials: 17
Product Name Type Development Stage Therapeutic Area Study Status Trial ID
nCPAP alone Other Phase PHASE2 Respiratory Distress Syndrome COMPLETED NCT02074059
Lucinactant for Inhalation Other Phase PHASE2 Respiratory Distress Syndrome COMPLETED NCT02074059
nCPAP alone Other Phase PHASE2 Respiratory Distress Syndrome TERMINATED NCT02528318
Lucinactant for inhalation Other Phase PHASE2 Respiratory Distress Syndrome TERMINATED NCT02528318
nCPAP Other Phase PHASE2 Respiratory Distress Syndrome COMPLETED NCT02636868
Lucinactant delivered via investigational delivery device Device Phase PHASE2 Respiratory Distress Syndrome COMPLETED NCT02636868
Losartan Other Phase PHASE2 Hypertension COMPLETED NCT03217825
Rostafuroxin Other Phase PHASE2 Hypertension COMPLETED NCT03217825
nCPAP Only Other Phase PHASE2 Respiratory Distress Syndrome, Newborn TERMINATED NCT04264156
Lucinactant for Inhalation Other Phase PHASE2 Respiratory Distress Syndrome, Newborn TERMINATED NCT04264156
Istaroxime Other Phase PHASE2 Acute Decompensated Heart Failure COMPLETED NCT02617446
Placebo Other Phase PHASE2 Acute Decompensated Heart Failure COMPLETED NCT02617446
Lucinactant Other Phase PHASE2 COVID-19 COMPLETED NCT04389671
Placebo Other Phase PHASE2 Cardiogenic Shock COMPLETED NCT04325035
Istaroxime Other Phase PHASE2 Cardiogenic Shock COMPLETED NCT04325035
TH1902 Other Phase PHASE1 Solid Tumor ACTIVE_NOT_RECRUITING NCT04706962
Placebo Other Phase PHASE1 Cardiogenic Shock ACTIVE_NOT_RECRUITING NCT05975021
Istaroxime Other Phase PHASE1 Cardiogenic Shock ACTIVE_NOT_RECRUITING NCT05975021
TH1902 DRUG Phase PHASE1 Solid Tumor ACTIVE_NOT_RECRUITING NCT04706962
nCPAP Only OTHER Phase PHASE2 Respiratory Distress Syndrome, Newborn TERMINATED NCT04264156
Losartan DRUG Phase PHASE2 Hypertension COMPLETED NCT03217825
Rostafuroxin DRUG Phase PHASE2 Hypertension COMPLETED NCT03217825
nCPAP DRUG Phase PHASE2 Respiratory Distress Syndrome COMPLETED NCT02636868
Lucinactant delivered via investigational delivery device DRUG Phase PHASE2 Respiratory Distress Syndrome COMPLETED NCT02636868
Istaroxime DRUG Phase PHASE1 Cardiogenic Shock ACTIVE_NOT_RECRUITING NCT05975021
nCPAP alone DEVICE Phase PHASE2 Respiratory Distress Syndrome TERMINATED NCT02528318
Lucinactant for Inhalation DRUG Phase PHASE2 Respiratory Distress Syndrome COMPLETED NCT02074059
Placebo first DRUG Phase PHASE2 Cystic Fibrosis COMPLETED NCT00934362
Lucinactant first DRUG Phase PHASE2 Cystic Fibrosis COMPLETED NCT00934362
Aerosolized lucinactant DRUG Phase PHASE2 Respiratory Distress Syndrome TERMINATED NCT00807235
B.2 Lucinactant DRUG Phase PHASE2 Acute Respiratory Distress Syndrome TERMINATED NCT00215553
B.1 Lucinactant DRUG Phase PHASE2 Acute Respiratory Distress Syndrome TERMINATED NCT00215553
A.4 Lucinactant DRUG Phase PHASE2 Acute Respiratory Distress Syndrome TERMINATED NCT00215553
A.3 Lucinactant DRUG Phase PHASE2 Acute Respiratory Distress Syndrome TERMINATED NCT00215553
A.2 Lucinactant DRUG Phase PHASE2 Acute Respiratory Distress Syndrome TERMINATED NCT00215553
B.3 SoC OTHER Phase PHASE2 Acute Respiratory Distress Syndrome TERMINATED NCT00215553
A.1 Lucinactant DRUG Phase PHASE2 Acute Respiratory Distress Syndrome TERMINATED NCT00215553
Placebo DRUG Phase PHASE1 Cardiogenic Shock ACTIVE_NOT_RECRUITING NCT05975021
Lucinactant 90 mg/kg DRUG Phase PHASE2 Respiratory Distress Syndrome, Newborn TERMINATED NCT00215540
Lucinactant 175 mg/kg DRUG Phase PHASE2 Respiratory Distress Syndrome, Newborn TERMINATED NCT00215540
Sham Comparator OTHER Phase PHASE2 Acute Hypoxemic Respiratory Failure COMPLETED NCT00578734
PSV+VG mode versus SIMV+VG mode PROCEDURE Preclinical Respiratory Distress Syndrome SUSPENDED NCT00295230
Standard Care OTHER Phase PHASE3 Meconium Aspiration TERMINATED NCT00004500
Lucinactant DRUG Phase PHASE2 COVID-19 COMPLETED NCT04389671
Total products: 44