Levosimendan Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Levosimendan has a well-established evaluation profile supported by numerous clinical trials across Phase I through Phase IV. Sponsored by academic medical centers, university hospitals, medical research agencies, and major pharmaceutical entities such as Abbott, these studies evaluate efficacy, safety, pharmacokinetics, hemodynamic stabilization, and patient survival in acute heart failure, heart failure with reduced ejection fraction (NYHA Class III and IV), cardiogenic shock, septic shock, and myocardial protection during cardiac surgery. Trial statuses encompass completed, active recruitment, not yet recruiting, and terminated studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07436689	ENROLLING_BY_INVITATION	Pulmonary Hypertension Associated With HFpEF	Tenax Therapeutics, Inc.	2026-03-13	PHASE3
NCT07288398	RECRUITING	Pulmonary Hypertension Associated With HFpEF	Tenax Therapeutics, Inc.	2026-03-03	PHASE3
NCT07105202	RECRUITING	Mechanical Ventilation; Weaning Failure	Radboud University Medical Center	2025-09-17	PHASE4
NCT07664748	NOT_YET_RECRUITING	Heart Failure	Niguarda Hospital	2026-06-30
NCT04020263	RECRUITING	Cardiogenic Shock	Pr Bruno LEVY	2023-07-03	PHASE3
NCT07262723	NOT_YET_RECRUITING	Acute Decompensated Heart Failure (ADHF)	Chittagong Medical College	2025-12-01	PHASE2; PHASE3
NCT05983250	ACTIVE_NOT_RECRUITING	Pulmonary Hypertension	Tenax Therapeutics, Inc.	2024-01-10	PHASE3
NCT05664191	COMPLETED	Sub-arachnoid Haemorrhage	Assistance Publique - Hôpitaux de Paris	2023-10-13	PHASE2
NCT05768230	UNKNOWN	Transesophageal Echocardiography; Acute Respiratory Distress Syndrome; Right Ventricular Dysfunction	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	2023-03-22	PHASE2; PHASE3
NCT05233202	UNKNOWN	Patients Referred for an Isolated or a Combined Surgical Correction of Functional Moderate to Severe Tricuspid	Assistance Publique - Hôpitaux de Paris	2023-01-23	PHASE3
NCT06478667	COMPLETED	Acute Myocarditis	Ain Shams University	2024-12-20	PHASE3
NCT05956431	UNKNOWN	Heart Arrest	Peking University Third Hospital	2023-08-01	PHASE4
NCT04728932	COMPLETED	Cardiogenic Shock; Extracorporeal Membrane Oxygenation Complication	Assistance Publique - Hôpitaux de Paris	2021-08-27	PHASE3
NCT06387862	UNKNOWN	Left Ventricular Dysfunction	Universitair Ziekenhuis Brussel	2024-02-01	PHASE2
NCT05222256	COMPLETED	Open Heart Surgery	Assiut University	2022-03-25
NCT06784570	COMPLETED	Cardiac Surgery; Low Ejection Fraction	Zagazig University	2021-01-01	PHASE2
NCT04705337	TERMINATED	Heart Failure New York Heart Association Class III; Heart Failure New York Heart Association Class IV; Heart Failure, Systolic; Heart Failure With Reduced Ejection Fraction	Medical University of Bialystok	2021-12-15	PHASE4
NCT04718350	COMPLETED	Hypertension, Pulmonary; Cardiac Failure; Pulmonary Vascular Resistance Abnormality	Aretaieion University Hospital	2021-01-27
NCT04329624	COMPLETED	Cardiovascular Risk Factor	Medical University of Vienna	2020-10-10	PHASE3
NCT04158674	TERMINATED	Acute Decompensated Heart Failure	Centre Hospitalier Universitaire Dijon	2020-02-24	PHASE3
NCT03624010	COMPLETED	Hypertension Pulmonary Secondary Heart Failure; Right Sided Heart Failure With Normal Ejection Fraction; Heart Failure With Normal Ejection Fraction	Tenax Therapeutics, Inc.	2019-04-09	PHASE2
NCT04330755	COMPLETED	Aortic Coarctation	Dalia Saad Abd-El Kader	2021-02-04	PHASE4
NCT04970238	UNKNOWN	ST Elevation Myocardial Infarction; Heart Failure	Zhijun Sun	2021-10	PHASE4
NCT04599816	COMPLETED	Hypertension, Pulmonary; Cardiac Failure; Pulmonary Vascular Resistance Abnormality	Aretaieion University Hospital	2020-10-17
NCT04950569	UNKNOWN	Heart Failure	Tongji Hospital	2020-10-29	PHASE4
NCT04573049	UNKNOWN	Aortic Valve Stenosis; Heart Failure; Inotropic Agents; Safety Issues; Effect of Drug; Cardiac Event; Transcatheter Aortic Valve Replacement	China National Center for Cardiovascular Diseases	2020-09-01	PHASE4
NCT04179604	UNKNOWN	Cardiac Output, Low	María de los Ángeles Tena Pajuelo	2020-06-17	PHASE2; PHASE3
NCT03189901	UNKNOWN	Early Management; Acute Heart Failure; NSTEMI - Non-ST Segment Elevation MI	Qilu Hospital of Shandong University	2017-07-01	PHASE4
NCT03764722	UNKNOWN	Systolic Heart Failure	Collegium Medicum w Bydgoszczy	2018-08-01	PHASE4
NCT04020003	UNKNOWN	ARDS, Human	Shenzhen Second People's Hospital	2019-07-01	PHASE3
NCT05063370	UNKNOWN	Right Heart Failure; Open-heart Surgery	Ain Shams University	2021-08-18	PHASE2
NCT04705337	Not yet recruiting	Heart Failure New York Heart Association Class III\|Heart Failure New York Heart Association Class IV\|Heart Failure Systolic\|Heart Failure With Reduced Ejection Fraction	Medical University of Bialystok\|Medical Research Agency Poland\|University of Opole\|Medical University of Lodz\|Poznan University of Medical Sciences\|Nicolaus Copernicus University\|National Institute of Cardiology Warsaw Poland\|John Paul II Hospital Krakow\|Azienda Ospedaliera dei Colli	2021-01-01	Phase 4
NCT02531724	COMPLETED	Acute Kidney Injury; Renal Insufficiency, Acute	Sahlgrenska University Hospital	2015-09	PHASE4
NCT03948178	TERMINATED	Amyotrophic Lateral Sclerosis	Orion Corporation, Orion Pharma	2019-06-26	PHASE3
NCT04635293	COMPLETED	Cardiac Disease; Cardiac Failure; Cardiac Surgery; Inotropes; Ejection Fraction	Aretaieion University Hospital	2012-01-01
NCT03505021	COMPLETED	Amyotrophic Lateral Sclerosis	Orion Corporation, Orion Pharma	2018-06-21	PHASE3
NCT03576677	UNKNOWN	Heart Failure	Finn Gustafsson	2019-08-01	PHASE4
NCT03699215	UNKNOWN	ST Elevation Myocardial Infarction	Hospital Universitario de Canarias	2018-11-17	PHASE3
NCT03541603	COMPLETED	Hypertension Pulmonary Secondary; Heart Failure, Right Sided; Heart Failure With Normal Ejection Fraction	Tenax Therapeutics, Inc.	2018-11-14	PHASE2
NCT04252404	Completed	Acute Heart Failure	Arcothova	2020-02-03	--
NCT05076864	Recruiting	Pharmacokinetics\|Metabolites\|Intensive Care\|Renal Failure\|Acute Kidney Injury	Karolinska Institutet\|Karolinska University Hospital	2020-01-01	--
NCT03855579	UNKNOWN	Hemodynamics	Assiut University	2019-03-06	PHASE4
NCT03437226	UNKNOWN	Heart Failure	Dr. Gerhard Pölzl	2018-03-08	PHASE3
NCT02640846	UNKNOWN	Septic Shock; Cardiomyopathy	Sahlgrenska University Hospital	2015-12	PHASE4
NCT04323709	Completed	Cardiogenic Shock\|Refractory Shock	Hospices Civils de Lyon	2019-01-01	--
NCT01500785	TERMINATED	Myocardial Stunning	Tampere University Hospital	2018-06-15	PHASE4
NCT03022877	WITHDRAWN	Myocardial Infarction; Outcome	RWTH Aachen University	2017-06
NCT03681379	Unknown status	Acute Heart Failure	Nantes University Hospital	2018-10-01	--
NCT03557255	COMPLETED	Heart Failure	National Cancer Institute, Egypt	2017-08-01	PHASE2
NCT02963454	UNKNOWN	Septic Shock	Military Hospital of Tunis	2011-01
NCT01720030	COMPLETED	Acute Kidney Injury	VieCuri Medical Centre	2016-09	PHASE2; PHASE3
NCT02133105	COMPLETED	Cardiorenal Syndrome	Göteborg University	2014-04	PHASE3
NCT02232399	COMPLETED	Congenital Heart Defects	Göteborg University	2014-10-15	PHASE2
NCT02025621	COMPLETED	Coronary Artery Bypass Grafting; Mitral Valve Surgery; Low Cardiac Output Syndrome	Tenax Therapeutics, Inc.	2014-07	PHASE3
NCT01721434	UNKNOWN	Muscle Weakness Conditions; Weaning Failure	University Medical Center Nijmegen	2012-09	PHASE2; PHASE3
NCT00994825	COMPLETED	Low Cardiac Output Syndrome	Università Vita-Salute San Raffaele	2009-11	PHASE4
NCT02408003	COMPLETED	Heart Failure, Diastolic; Aortic Valve Stenosis; Monitoring, Physiologic; Physiology	Sahlgrenska University Hospital	2014-03
NCT02184819	COMPLETED	Coronary Artery Bypass Grafting; Left Ventricular Dysfonction	Assistance Publique - Hôpitaux de Paris	2013-06	PHASE3
NCT01290146	TERMINATED	Advanced Chronic Heart Failure	Niguarda Hospital	2011-02	PHASE3
NCT01595737	COMPLETED	Cardiac Surgery	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	2011-02	PHASE4
NCT02261948	COMPLETED	Heart Failure	Centro Cardiologico Monzino	2012-09	PHASE4
NCT01318460	COMPLETED	Coronary Artery Disease	AHEPA University Hospital	2011-03	PHASE4
NCT00988806	UNKNOWN	Advanced Heart Failure	Hospital Universitario de Canarias	2009-11	PHASE4
NCT02012946	UNKNOWN	Cardiovascular Diseases	Azienda Policlinico Umberto I	2013-12	PHASE4
NCT01536132	COMPLETED	Heart Failure	Parc de Salut Mar	2010-04	PHASE4
NCT01188369	TERMINATED	Diastolic Dysfunction; Left Ventricular Hypertrophy	University of Aarhus	2010-09	PHASE4
NCT01219712	UNKNOWN	Left Ventricular Dysfunction; Femoral Fracture	University Hospital, Linkoeping	2011-01
NCT01969071	COMPLETED	Mitral Valve Stenosis With Incompetence or Regurgitation	Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital	2009-07	PHASE4
NCT01022983	WITHDRAWN	Heart Failure; Hip Fracture	Sykehuset i Vestfold HF	2011-04	PHASE4
NCT01301313	TERMINATED	Acute Heart Failure	Jose Luis Vazquez Martinez	2011-02	PHASE2
NCT01616069	COMPLETED	Cardiopulmonary Bypass Graft	Federal University of Juiz de Fora	2012-02	PHASE4
NCT00324766	COMPLETED	Myocardial Infarction; Heart Failure; Cardiogenic Shock	Oslo University Hospital	2006-06	PHASE4
NCT01065194	UNKNOWN	Chronic Stable Heart Failure	Medical University Innsbruck	2009-08	PHASE3
NCT01120106	COMPLETED	Low Cardiac Output Syndrome	Bambino Gesù Hospital and Research Institute	2009-01	PHASE2
NCT01576094	COMPLETED	Low Cardiac Output Syndrome	Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz	2009-11	PHASE1; PHASE2
NCT01210976	COMPLETED	Heart Valve Disease	Tampere University Hospital	2009-01	PHASE4
NCT01101620	COMPLETED	Respiratory Muscle Function	University Medical Center Nijmegen	2010-04
NCT00695929	COMPLETED	Congenital Cardiovascular Defects; Low Cardiac Output Syndrome	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	2008-07
NCT00698763	COMPLETED	Transient Ischemic Attack; Stroke	Orion Corporation, Orion Pharma	2008-08	PHASE2
NCT00154115	COMPLETED	Heart Failure	Kuopio University Hospital	2005-03	PHASE4
NCT01221116	TERMINATED	Heart Failure; Cardiac Surgery	Ullevaal University Hospital	2003-01
NCT00585104	COMPLETED	Heart Failure	University of Utah	2006-09	PHASE2
NCT00800306	COMPLETED	Septic Shock	University of Roma La Sapienza	2007-11	PHASE2
NCT00610350	COMPLETED	Myocardial Protection	University of Roma La Sapienza	2005-01	PHASE4
NCT00166127	TERMINATED	Heart Failure	Emory University	2005-05	PHASE3
NCT00219388	COMPLETED	Heart Failure	Orion Corporation, Orion Pharma	2002-11	PHASE4
NCT00527059	UNKNOWN	Heart Failure; Renal Insufficiency	University of Roma La Sapienza	2007-10	PHASE4
NCT00348504	COMPLETED	Acute Heart Failure	Abbott	2003-03	PHASE3
NCT00093301	UNKNOWN	Cardiogenic Shock; Septic Shock	Wentworth Area Health Services	2004-10	PHASE2; PHASE3
NCT00549107	UNKNOWN	Low Cardiac Output Syndrome	Ludwig Boltzmann Gesellschaft	2007-09	PHASE2
NCT00048425	COMPLETED	Heart Failure, Congestive	Abbott	2002-09	PHASE3
NCT00130884	COMPLETED	Chronic Heart Failure; Heart Diseases	Orion Corporation, Orion Pharma	2005-03	PHASE2
NCT00130871	COMPLETED	Coronary Heart Disease	Orion Corporation, Orion Pharma	2004-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-20)

Check the Levosimendan product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Levosimendan selectively binds in a calcium-dependent manner to cardiac troponin C (cTnC), stabilizing troponin C in its calcium-bound conformation and increasing myofilament calcium sensitivity. This sensitizing effect enhances myocardial contractility without elevating intracellular calcium levels or myocardial oxygen consumption, providing crucial inotropic support and improved cardiac output in clinical trial settings such as acute heart failure, cardiogenic shock, and perioperative cardiac surgery.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).