Levosimendan

drug
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Also known as (-)-OR-1259(r)-simendanNSC-759644OR-1259OR1259SimdaxSimendan, (r)-SID144205744SID170466129SID170466128

Summary

Levosimendan (CHEMBL2051955) is a phase-3 clinical-stage small-molecule vasodilator agent (ATC C01CX08); indicated across 16 conditions including heart failure and congestive heart failure.

At a glance

  • Status: Max clinical phase 3 (not approved)
  • Modality: Small molecule
  • ATC class: C01CX08
  • Indications: 16 conditions
  • Clinical trials: 89
  • Chemistry: 280.28 Da · C14H12N6O

Identifiers

Drug identity and classification

FieldValue
ChEMBL IDCHEMBL2051955
NameLevosimendan
TypeSmall molecule
Max phase3
FDA approvedno
PubChem CID3033825
ChEBICHEBI:50567
ATCC01CX08
Molecular formulaC14H12N6O
Molecular weight280.28
InChIKeyWHXMKTBCFHIYNQ-SECBINFHSA-N

SMILES: C[C@@H]1CC(=O)NN=C1C2=CC=C(C=C2)NN=C(C#N)C#N

IUPAC name: 2-[[4-[(4R)-4-methyl-6-oxo-4,5-dihydro-1H-pyridazin-3-yl]phenyl]hydrazinylidene]propanedinitrile

Pharmacological roles (ChEBI): vasodilator agent, EC 3.1.4.17 (3’,5’-cyclic-nucleotide phosphodiesterase) inhibitor, cardiotonic drug, anti-arrhythmia drug.

Also known as: (-)-OR-1259, (r)-simendan, Levosimendan, NSC-759644, OR-1259, OR1259, Simdax, Simendan, (r)-, LEVOSIMENDAN, SID144205744, SID170466129, SID170466128

Patent coverage: 810 distinct patent families (3,145 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 2 (assay-derived). Sample: Troponin C, slow skeletal and cardiac muscles, Phosphodiesterase 3.

Bioactivity

ChEMBL activities: 1 potent at pChembl ≥ 5 of 2 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

TargetpChemblTypeValueUnitActivity ID
PDE3B8.1IC508nMCHEMBL_ACT_1206298

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

16 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

IndicationTrial phaseMONDOEFO
heart failure3MONDO:0005252EFO:0003144
congestive heart failure3MONDO:0005009EFO:0000373
severe acute respiratory syndrome3MONDO:0005091EFO:0000694
ST-elevation myocardial infarction3MONDO:0041656EFO:0008585
cardiovascular disorder3MONDO:0004995EFO:0000319
amyotrophic lateral sclerosis3MONDO:0004976MONDO:0004976
toxic shock syndrome2MONDO:0001881EFO:0006834
congenital heart disease2MONDO:0005453EFO:0005207
acute kidney injury2MONDO:0002492HP:0001919
muscle tissue disorder2MONDO:0003939EFO:0002970
stroke disorder2MONDO:0005098EFO:0000712
coronary artery disorder2MONDO:0005010EFO:0001645
transient ischemic attack2MONDO:0005264EFO:0003764
heart disorder2MONDO:0005267EFO:0003777

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 89.

Phase distribution

PhaseTrials
PHASE430
PHASE319
Not specified18
PHASE215
PHASE2/PHASE36
PHASE1/PHASE21

Top trials by phase / activity

NCTPhaseStatusTitle
NCT07105202PHASE4RECRUITINGShorter Weaning From Invasive Ventilation With Levosimendan
NCT00154115PHASE4COMPLETEDLevosimendan in High Risk Heart Valve Surgery
NCT00219388PHASE4COMPLETEDEfficacy and Safety of Treatment With Simdax® Versus Dobutrex® in Decompensated Heart Failure Patients.
NCT00324766PHASE4COMPLETEDLevosimendan in Acute Heart Failure Following Acute Myocardial Infarction.
NCT00610350PHASE4COMPLETEDLevosimendan and Myocardial Protection
NCT00988806PHASE4UNKNOWNLong-Term Intermittent Administration of Levosimendan in Patients With Advanced Heart Failure
NCT00994825PHASE4COMPLETEDLevosimendan in High Risk Patients Undergoing Cardiac Surgery
NCT01022983PHASE4WITHDRAWNPreoperative Levosimendan and Heart Failure
NCT01188369PHASE4TERMINATEDEffects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
NCT01210976PHASE4COMPLETEDThe Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting (CABG) Surgery
NCT01318460PHASE4COMPLETEDProphylactic Administration of Levosimendan in Patients Undergoing Coronary Surgery
NCT01500785PHASE4TERMINATEDIntracoronary Administration of Levosimendan in Cardiac Surgery Patients
NCT01536132PHASE4COMPLETEDIntermittent Intravenous Levosimendan in Ambulatory Advanced Chronic Heart Failure Patients
NCT01595737PHASE4COMPLETEDComparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery
NCT01616069PHASE4COMPLETEDAssessment of Hemodynamic Response in Cardiopulmonary Bypass Graft After Cardiopulmonary Bypass Using Transesophegeal Echocardiography
NCT01969071PHASE4COMPLETEDThe Effects of Levosimendan During Mitral Valve Surgery
NCT02012946PHASE4UNKNOWNLevosimendan Versus Dobutamine in Cardiopatic Patients Undergoing Major Non Cardiac Surgery
NCT02261948PHASE4COMPLETEDLevosimendan Efficacy Assessment by Cardiopulmonary Exercise Test (CPET)
NCT02531724PHASE4COMPLETEDEffects of Levosimendan in Acute Kidney Injury After Cardiac Surgery
NCT02640846PHASE4UNKNOWNEffects of Levosimendan, Milrinone and Norepinephrine on Left and Right Ventricular Function in Septic Shock
NCT03189901PHASE4UNKNOWNEarly Management Strategies of Acute Heart Failure for Patients With NSTEMI
NCT03576677PHASE4UNKNOWNEffect of Levosimendan or Placebo on Exercise in Advanced Chronic Heart Failure
NCT03764722PHASE4UNKNOWNEffectiveness of a Repetitive Use of 24-hour Levosimendan Infusions in Patients With Severe Systolic Heart Failure in Order to Prevent Rehospitalizations
NCT03855579PHASE4UNKNOWNLevosimendan Versus Milrinone in Off Pump CABG Surgery
NCT04330755PHASE4COMPLETEDLevosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy
NCT04573049PHASE4UNKNOWNThe Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
NCT04705337PHASE4TERMINATEDLevosimendan In Ambulatory Heart Failure Patients
NCT04950569PHASE4UNKNOWNEffect of Levosimendan on miRNAs Regulation in the Failing Hearts
NCT04970238PHASE4UNKNOWNEffect of Levosimendan on Left Ventricular Systolic Function and Heart Failure After PCI in Patients With Acute Anterior Myocardial Infarction
NCT05956431PHASE4UNKNOWNRCT Study of Levosimendan Improving Prognosis of Cardiac Arrest
NCT04020263PHASE3RECRUITINGEffect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock
NCT07262723PHASE2/PHASE3NOT_YET_RECRUITINGLevosimendan in Acute Decompensated Heart Failure
NCT00048425PHASE3COMPLETEDEvaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.
NCT00093301PHASE2/PHASE3UNKNOWNLevosimendan Versus Dobutamine in Shock Patients
NCT00166127PHASE3TERMINATEDStudy of Blood Concentrations and Physiologic Effects of Levosimendan Given During Heart Surgery
NCT00348504PHASE3COMPLETEDSurvival 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.
NCT01065194PHASE3UNKNOWNEfficacy and Safety of Pulsed Infusions of Levosimendan in Outpatients With Advanced Heart Failure
NCT01290146PHASE3TERMINATEDELEVATE Early LEvosimendan Vs Usual Care in Advanced Chronic hearT failurE
NCT01720030PHASE2/PHASE3UNKNOWNLevosimendan in Acute Kidney Injury Study
NCT01721434PHASE2/PHASE3UNKNOWNEffects of Levosimendan on Diaphragm Function in Mechanically Ventilated Patients

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).