5 completed, 2 withdrawn, 1 active not recruiting, 1 recruiting. 6 Phase 2, 3 Phase 1, 1 Early Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 3, Active not recruiting 1, Recruiting 1, Withdrawn 1 |
| Phase 1 | 3 | Active not recruiting 1, Completed 1, Withdrawn 1 |
| Early Phase 1 | 1 | Completed 1 |
| Phase 3 | 1 | Recruiting 1 |
Follow Istaroxime: new trials by email Literature Review of Istaroxime trials Research Report on Istaroxime
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Randomized Evaluation of Istaroxime for Stabilization in Acute Heart Failure-Cardiogenic Shock istaroxime, placebo - Cardiogenic Shock | Phase 2 / Phase 3 | Recruiting | Seismic Pharmaceuticals Operations LLC | 600 | 2026-09-09 | 2026-09-23 |
| A Safety and Efficacy Trial of Istaroxime for Cardiogenic Shock Stage C Istaroxime, Placebo - Cardiogenic Shock | Phase 1 / Phase 2 | Active not recruiting | Windtree Therapeutics | 20 | 2024-06-01 | 2025-08-20 |
| The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock Istaroxime, Placebo - Cardiogenic Shock | Phase 2 | Completed | Windtree Therapeutics | 90 | 2020-09-28 | 2025-02-04 |
| The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acute Decompensated Heart Failure Placebo, Istaroxime - Acute Decompensated Heart Failure | Phase 2 | Completed | Windtree Therapeutics | 120 | 2015-12-01 | 2023-05-24 |
| Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a Istaroxime, Exercise - Heart Failure, Congestive | Early Phase 1 | Completed | Benjamin Levine | 26 | 2015-09-15 | 2022-06-29 |
| Istaroxime Infusion for 24 Hours in Chinese Healthy Volunteers istaroxime, 9% Saline (NS) - Healthy | Phase 1 | Completed | Lee's Pharmaceutical Limited | 32 | 2015-03-01 | 2025-08-13 |
| Safety and Efficacy Study of Istaroxime in Acute Decompensated Heart Failure Patients Istaroxime, Placebo - Heart Failure | Phase 2 | Withdrawn | Debiopharm International SA | 2009-06-01 | 2014-10-23 | |
| Phase I Interaction Study of Istaroxime and Digoxin in Subjects With Stable Heart Failure Istaroxime - Heart Failure | Phase 1 | Withdrawn | Debiopharm International SA | 2009-06-01 | 2014-10-23 | |
| A Phase II Trial to Assess Hemodynamic Effects of Istaroxime in Pts With Worsening HF and Reduced LV Systolic Function Istaroxime, Placebo - Heart Failure | Phase 2 | Completed | sigma-tau i.f.r. S.p.A. | 120 | 2006-08-01 | 2008-02-15 |
Heart Failure (5) · Shock, Cardiogenic (3)
Windtree Therapeutics (3) · Debiopharm International SA (2) · Benjamin Levine (1) · Lee's Pharmaceutical Limited (1) · Seismic Pharmaceuticals Operations LLC (1) · sigma-tau i.f.r. S.p.A. (1)
Italy (3) · United States (3) · Argentina (2) · China (2) · Poland (2) · Armenia (1) · Israel (1)
Benjamin D Levine, MD (1) · Cezar Macarie, MD (1) · Dimitrios Th Kremastinos, MD (1) · Gabe Coitler (1) · Giuseppe Bianchi, MD (1) · Hein Van Ingen, M.D. (1) · Jaroslaw Drodz, MD (1) · Jerzy Korewicki, MD (1) · John N Nanas, MD PhD (1) · Marco Metra, MD (1) · Maria Dorobantu, MD (1) · Mihai Gheorghiade, MD FACC (1) · Piotr Ponikowski, MD (1) · Serban I Bubenek-Turconi, MD (1) · Steven G Simonson, MD (1)
PMID 18534276, PMID 19464414, PMID 31975496, PMID 35867804, PMID 37075941, PMID 37086245
R01AG017479 (1)