Simdax

(levosimendan)

Phase 3Small molecule

Levosimendan is used to treat acute heart failure in patients with reduced heart function, helping the heart pump blood more effectively and improving symptoms like shortness of breath and fatigue.[1] Simdax is currently being investigated across 6 indications[3], with its most advanced program in Phase 3.[1]

Simdax is one of 186 small molecule programs targeting Congestive Heart Failure. It is currently in Phase 3.

Indications

Total Trials

Active Trials

185

Competitors

Pipeline

Status by Indication[3][1]

Indication

Congestive Heart FailureUnknown

Heart FailureCompleted

Cardiovascular DiseaseUnknown

Hip FractureActive, not recruiting

SepsisActive, not recruiting

CardiacCompleted

Congestive Heart FailurePreclinical

Unknown

Heart FailurePhase 3

Completed

Cardiovascular DiseasePreclinical

Unknown

Hip FracturePreclinical

Active, not recruiting

SepsisPreclinical

Active, not recruiting

CardiacPreclinical

Completed

Competition

Competitive Landscape

206 competitors in Heart Failure

#DrugCompanyPhaseTrials

Simdax

Orion Corporation, Orion Pharma

Phase 3

18 2

Amidate

Pfizer

Preclinical

1 3

Savaysa

Xifaxan

2 5

Tamiflu

CConrado Roberto Hoffmann Filho

Preclinical

1 6

Potassium Iodide

MMeda Pharmaceuticals

Preclinical

1 7

Oraverse

LLife Extension Foundation Inc.

Preclinical

1 8

Statin

Bristol-Myers Squibb

Preclinical

1 9

Neo-Synephrine

EExela Pharma Sciences, LLC.

Preclinical

—10

Optimal Medical Therapy

HHelios Health Institute GmbH

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2/3Not yet recruiting

Heart Failure

NCT07262723

Q2 2028

PreclinicalNot yet recruiting

Heart Failure

NCT07664748

Q3 2028

Post-ApprovalRecruiting

Ventilation

NCT07105202

Clinical

Trials by Indication[1]

Heart Failure18 trials

ELEVATE Early LEvosimendan Vs Usual Care in Advanced Chronic hearT failurE

Terminated·NNiguarda Hospital·Phase 3·NCT01290146·13 enrolled

Clinical Outcomes of Levosimendan Versus Dobutamine Versus Milrinone in Cases With Acute Decompensated Heart Failure With Impaired Renal Function

Completed·—··NCT07186062·60 enrolled

Interest of Levosimendan Preconditioning for Cardiac Surgery Under CEC in Heart Failure Patients With Impaired Ejection Fraction

Unknown status·—··NCT06021587·300 enrolled

Show 15 more trials

Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure

No longer available·TTenax Therapeutics, Inc.··NCT02973620

Efficacy and Safety of Pulsed Infusions of Levosimendan in Outpatients With Advanced Heart Failure

Unknown status·MMedical University Innsbruck·Phase 3·NCT01065194·120 enrolled

Efficacy and Safety of Treatment With Simdax® Versus Dobutrex® in Decompensated Heart Failure Patients.

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 4·NCT00219388·60 enrolled

Levosimendan In Ambulatory Heart Failure Patients

Terminated·MMedical University of Bialystok·Phase 4·NCT04705337·70 enrolled

Intermittent Intravenous Levosimendan in Ambulatory Advanced Chronic Heart Failure Patients

Completed·PParc de Salut Mar·Phase 4·NCT01536132·70 enrolled

Effect of Levosimendan or Placebo on Exercise in Advanced Chronic Heart Failure

Unknown status·FFinn Gustafsson·Phase 4·NCT03576677·42 enrolled

Levosimendan Versus Dobutamine for Renal Function in Heart Failure

Completed·GGöteborg University·Phase 3·NCT02133105·33 enrolled

Preoperative Levosimendan and Heart Failure

Withdrawn·SSykehuset i Vestfold HF·Phase 4·NCT01022983

Peroral Levosimendan in Chronic Heart Failure

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 2·NCT00130884·300 enrolled

Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.

Completed·AAbbott·Phase 3·NCT00048425·600 enrolled

Long-Term Intermittent Administration of Levosimendan in Patients With Advanced Heart Failure

Unknown status·HHospital Universitario de Canarias·Phase 4·NCT00988806·213 enrolled

Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.

Completed·AAbbott·Phase 3·NCT00348504·1,300 enrolled

Levosimendan in Acute Decompensated Heart Failure

Not yet recruiting·—·Phase 2/3·NCT07262723·332 enrolled

Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children

Terminated·JJose Luis Vazquez Martinez·Phase 2·NCT01301313·116 enrolled

AVATAR-HF (Artificial Voice Analysis and Telemonitoring for Heart Failure): Studio di fattibilità Sull'Uso Dell'Analisi Vocale Basata su Intelligenza Artificiale Per il Telemonitoraggio Dei Pazienti Con Insufficienza Cardiaca.

Not yet recruiting·NNiguarda Hospital·Preclinical·NCT07664748·60 enrolled

Cardiac Surgery4 trials

Levosimendan Versus Dobutamine in Cardiopatic Patients Undergoing Major Non Cardiac Surgery

Unknown status·AAzienda Policlinico Umberto I·Phase 4·NCT02012946·40 enrolled

Levosimendan Administration and Outcome in Cardiac Surgery

Completed·—··NCT02275013·159 enrolled

Levosimendan in Congenital Cardiac Surgery

Completed·CCliniques universitaires Saint-Luc- Université Catholique de Louvain·N/A·NCT00695929·50 enrolled

Show 1 more trial

Intracoronary Administration of Levosimendan in Cardiac Surgery Patients

Terminated·TTampere University Hospital·Phase 4·NCT01500785·50 enrolled

Surgery4 trials

Prophylactic Administration of Levosimendan in Patients Undergoing Coronary Surgery

Completed·—·Phase 4·NCT01318460·32 enrolled

Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery

Completed·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 4·NCT01595737·30 enrolled

Levosimendan Versus Milrinone in Off Pump CABG Surgery

Unknown status·—·Phase 4·NCT03855579·60 enrolled

Show 1 more trial

Two Inodilators Postsurgery in Neonates

Completed·FFundacion para la Investigacion Biomedica del Hospital Universitario la Paz·Phase 1/2·NCT01576094·20 enrolled

Septic Shock3 trials

Effects of Levosimendan, Milrinone and Norepinephrine on Left and Right Ventricular Function in Septic Shock

Unknown status·SSahlgrenska University Hospital·Phase 4·NCT02640846·30 enrolled

Effects of Levosimendan on Microcirculation in Septic Shock

Completed·UUniversity of Roma La Sapienza·Phase 2·NCT00800306·40 enrolled

Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock

Unknown status·MMilitary Hospital of Tunis·N/A·NCT02963454·50 enrolled

Hemodynamic3 trials

Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF

Completed·TTenax Therapeutics, Inc.·Phase 2·NCT03541603·44 enrolled

A Clinical Study on Levosimendan Improvement of Prognosis of ARDS Patients by Optimizing Pulmonary Hemodynamics

Unknown status·SShenzhen Second People's Hospital·Phase 3·NCT04020003·120 enrolled

Myocardial Hemodynamic Effects of Levosimendan

Completed·UUniversity of Utah·Phase 2·NCT00585104·10 enrolled

45 more indications

Acute Kidney Injury2 trials

Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery

Completed·SSahlgrenska University Hospital·Phase 4·NCT02531724·30 enrolled

Prospective, Randomized, Monocenter, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Levosimendan in Intensive Care Patients With Acute Kidney Injury

Completed·VVieCuri Medical Centre·Preclinical·NCT01720030·68 enrolled

Efficacy2 trials

Efficacy and Clinical Outcomes of Levosimendan in E-CPR

Unknown status·HHamad Medical Corporation··NCT05730907·100 enrolled

Levosimendan Efficacy Assessment by Cardiopulmonary Exercise Test (CPET)

Completed·CCentro Cardiologico Monzino·Phase 4·NCT02261948·42 enrolled

Function2 trials

Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 3·NCT03505021·496 enrolled

Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects

Completed·UUniversity Medical Center Nijmegen·N/A·NCT01101620·30 enrolled

Cardiac2 trials

Changes in Cardiac Deformation Following Physiologic Alterations and Inotropic Support.

Completed·SSahlgrenska University Hospital·N/A·NCT02408003·30 enrolled

Effect Levosimendan Administration on Postoperative NT-proBNP in Cardiac Risk Patients

Completed·MMedical University of Vienna·Phase 3·NCT04329624·230 enrolled

Mitral Valve Surgery1 trial

The Effects of Levosimendan During Mitral Valve Surgery

Completed·KKartal Kosuyolu Yuksek Ihtisas Education and Research Hospital·Phase 4·NCT01969071·140 enrolled

Cardiopulmonary Bypass1 trial

Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 2·NCT00130871·60 enrolled

Heart1 trial

Effect of Levosimendan on miRNAs Regulation in the Failing Hearts

Unknown status·TTongji Hospital·Phase 4·NCT04950569·136 enrolled

Myocardial Protection1 trial

Levosimendan and Myocardial Protection

Completed·UUniversity of Roma La Sapienza·Phase 4·NCT00610350·100 enrolled

CABG1 trial

Comparison Between Levosimendan and Adrenaline in CABG Patients

Unknown status·—·N/A·NCT05222256·52 enrolled

Aortic Stenosis1 trial

The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement

Unknown status·CChina National Center for Cardiovascular Diseases·Phase 4·NCT04573049·124 enrolled

Critically Ill Patients1 trial

Levosimendan Infusion in Critically Ill Patients With Cardiogenic Shock

Completed·UUniversity of Zurich··NCT04917497·43 enrolled

Left Ventricular Hypertrophy1 trial

Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy

Terminated·UUniversity of Aarhus·Phase 4·NCT01188369·20 enrolled

Infants1 trial

Levosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy

Completed·DDalia Saad Abd-El Kader·Phase 4·NCT04330755·40 enrolled

Ventilation1 trial

Shorter Weaning From Invasive Ventilation With Levosimendan

Recruiting·RRadboud University Medical Center·Phase 4·NCT07105202·250 enrolled

Clinical Trial1 trial

Clinical Trial in Patients Who Have Suffered a Heart Attack and Who Have Undergone Catheterization Treated With Levosimendan

Unknown status·HHospital Universitario de Canarias·Phase 3·NCT03699215·184 enrolled

Preoperative1 trial

Preoperative Levosimendan in CABG Patients With Poor LV Function

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02184819·335 enrolled

Cardiac Arrest1 trial

RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest

Unknown status·PPeking University Third Hospital·Phase 4·NCT05956431·60 enrolled

ARDS1 trial

Using TEE to Evaluate the Effect of Levosimendan on Patients With ARDS Associated With RVD During MV

Unknown status·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2/3·NCT05768230·58 enrolled

Weaning Failure1 trial

Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS

Terminated·—·Phase 3·NCT04158674·82 enrolled

Cardiogenic Shock1 trial

LEVOSIMENDAN to Facilitate Weaning From ECMO in Severe Cardiogenic Shock Patients

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04728932·206 enrolled

Congenital Heart Disease1 trial

Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease?

Completed·GGöteborg University·Phase 2·NCT02232399·72 enrolled

Sepsis1 trial

Global Longitudinal Strain Assessment in Cardiogenic Shock During Sepsis

Unknown status·AAzienda USL Toscana Centro··NCT04141410·35 enrolled

Open Heart Surgery1 trial

Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants

Unknown status·LLudwig Boltzmann Gesellschaft·Phase 2·NCT00549107·40 enrolled

Amyotrophic Lateral Sclerosis1 trial

Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension

Terminated· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 3·NCT03948178·227 enrolled

Concentration1 trial

Study of Blood Concentrations and Physiologic Effects of Levosimendan Given During Heart Surgery

Terminated·EEmory University·Phase 3·NCT00166127·1 enrolled

Oral1 trial

Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 2·NCT00698763·32 enrolled

Hip Fracture1 trial

Preoperative levosimendán and Hip Fracture

Completed·HHospital Universitario de Canarias··NCT02972918·19 enrolled

Coronary Artery Bypass1 trial

The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting (CABG) Surgery

Completed·TTampere University Hospital·Phase 4·NCT01210976·24 enrolled

Right Ventricular Dysfunction1 trial

Levosimendan Versus Placebo Before Tricuspid Valve Surgery in Patients With Right Ventricular Dysfunction

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT05233202·230 enrolled

Left Ventricular Systolic Dysfunction1 trial

Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass

Completed·TTenax Therapeutics, Inc.·Phase 3·NCT02025621·882 enrolled

Mechanically Ventilated Patients1 trial

Effects of Levosimendan on Diaphragm Function in Mechanically Ventilated Patients

Unknown status·UUniversity Medical Center Nijmegen·Phase 2/3·NCT01721434·42 enrolled

Myocardial Infarction1 trial

Effect of Levosimendan on Left Ventricular Systolic Function and Heart Failure After PCI in Patients With Acute Anterior Myocardial Infarction

Unknown status·ZZhijun Sun·Phase 4·NCT04970238·500 enrolled

Systolic Heart Failure1 trial

Effectiveness of a Repetitive Use of 24-hour Levosimendan Infusions in Patients With Severe Systolic Heart Failure in Order to Prevent Rehospitalizations

Unknown status·CCollegium Medicum w Bydgoszczy·Phase 4·NCT03764722·100 enrolled

Acute Myocardial Infarction1 trial

Levosimendan in Acute Heart Failure Following Acute Myocardial Infarction.

Completed·OOslo University Hospital·Phase 4·NCT00324766·61 enrolled

Ventricular Function1 trial

Levosimendan in Patients With Impaired Right Ventricular Function Undergoing Cardiac Surgery

Unknown status·—·Phase 2·NCT05063370·40 enrolled

Transposition of the Great Arteries1 trial

Levosimendan Administration in Neonates With Transposition of the Great Arteries

Completed·—·Phase 2·NCT01120106·63 enrolled

Shock1 trial

Levosimendan Versus Dobutamine in Shock Patients

Unknown status·WWentworth Area Health Services·Phase 2/3·NCT00093301·40 enrolled

Treatment1 trial

Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery

Terminated·UUllevaal University Hospital·N/A·NCT01221116·23 enrolled

After Cardiac Surgery1 trial

Impact of Levosimendan Preconditioning on Critical Care and In-hospital Lengths of Stay After Cardiac Surgery With Bypass Surgery

Unknown status·—··NCT05685537·120 enrolled

Postoperative Cardiac Surgery1 trial

Spanish Randomized Clinical Trial to Compare Levosimendan Versus Placebo in Postoperative Cardiac Surgery (SPARTANS)

Unknown status·MMaría de los Ángeles Tena Pajuelo·Phase 2/3·NCT04179604·300 enrolled

High Risk Patients1 trial

Levosimendan in High Risk Patients Undergoing Cardiac Surgery

Completed·UUniversità Vita-Salute San Raffaele·Phase 4·NCT00994825·1,000 enrolled

Valve Surgery1 trial

Levosimendan in High Risk Heart Valve Surgery

Completed·KKuopio University Hospital·Phase 4·NCT00154115·200 enrolled

ST Elevation Myocardial Infarction1 trial

Acute and Chronic Protective Effects of Peri-interventional Administration of Levosimendan in ST Elevation Myocardial Infarctions

Withdrawn·RRWTH Aachen University·N/A·NCT03022877

Abdominal Cancer Surgeries1 trial

Levosimendan for Cardiac Patients Undergoing Major Abdominal Cancer Surgeries

Completed·NNational Cancer Institute, Egypt·Phase 2·NCT03557255·60 enrolled

Sub-arachnoid Haemorrhage1 trial

Use of Levosimendan as Treatment of Aneurysmal SubArachnoid Hemorrhage

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05664191·30 enrolled

Sources

References

[1]
ClinicalTrials.gov — 81 trial records for levosimendan. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — levosimendan compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for levosimendan. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Orion Corporation, Orion Pharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Phosphodiesterase 3 Inhibitor; Troponin, Cardiac Muscle Positive Modulator[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Orion Corporation, Orion Pharma

Simdax

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2028

Q3 2028

Trials by Indication[1]

Heart Failure18 trials

Cardiac Surgery4 trials

Surgery4 trials

Septic Shock3 trials

Hemodynamic3 trials

Acute Kidney Injury2 trials

Efficacy2 trials

Function2 trials

Cardiac2 trials

Mitral Valve Surgery1 trial

Cardiopulmonary Bypass1 trial

Heart1 trial

Myocardial Protection1 trial

CABG1 trial

Aortic Stenosis1 trial

Critically Ill Patients1 trial

Left Ventricular Hypertrophy1 trial

Infants1 trial

Ventilation1 trial

Clinical Trial1 trial

Preoperative1 trial

Cardiac Arrest1 trial

ARDS1 trial

Weaning Failure1 trial

Cardiogenic Shock1 trial

Congenital Heart Disease1 trial

Sepsis1 trial

Open Heart Surgery1 trial

Amyotrophic Lateral Sclerosis1 trial

Concentration1 trial

Oral1 trial

Hip Fracture1 trial

Coronary Artery Bypass1 trial

Right Ventricular Dysfunction1 trial

Left Ventricular Systolic Dysfunction1 trial

Mechanically Ventilated Patients1 trial

Myocardial Infarction1 trial

Systolic Heart Failure1 trial

Acute Myocardial Infarction1 trial

Ventricular Function1 trial

Transposition of the Great Arteries1 trial

Shock1 trial

Treatment1 trial

After Cardiac Surgery1 trial

Postoperative Cardiac Surgery1 trial

High Risk Patients1 trial

Valve Surgery1 trial

ST Elevation Myocardial Infarction1 trial

Abdominal Cancer Surgeries1 trial

Sub-arachnoid Haemorrhage1 trial

References

Drug Info

Quick Facts

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