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levosimendan

Small moleculeexperimental

Levosimendan (INN) is a calcium sensitizer used in the management of acutely decompensated congestive heart failure. It is marketed under the trade name Simdax. Overall the drug has a two fold mechanism of action. It leads to greater inotropy by increasing the calcium sensitivity as it binds to troponin and this results in a greater positive inotrophic force. Secondly, the drug is able to open ATP-sensitive potassium channels in vascular smooth muscle cells, and the vascular dilatory effects of the drug lead to a decreased preload and afterload, putting less work on the heart. This drug is in the process of review by the FDA but has not been approved for use in the United States yet. — Wikipedia

Clinical trial activity

91 trials · 94 clinical orgs · 0 marketing orgs

Phase 1
3
Phase 2
39
Phase 3
28
Phase 4
33

Earliest trial started Sep 1, 2002 (NCT00048425)

Timeline

2000s

  1. Jan 1, 2002

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@H]1CC(=O)NN=C1c1ccc(NN=C(C#N)C#N)cc1
Mol. weight
280.29 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • ((4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazono)propanedinitrile
  • dextrosimendan
  • levosimedan
  • levosimedan
  • levosimendan
  • levosimendan
  • levosimendan
  • levosimendan
  • levosimendan
  • levosimendan
  • levosimendan
  • levosimendan
  • levosimendan
  • levosimendanum
  • levosimendanum
  • odm-109
  • (-)-or-1259
  • (-)-or-1259
  • or 1259
  • or-1259
  • or-1855
  • (r)-simendan
  • simadax
  • simdax
  • simdax
  • simdax
  • simdax
  • simendan
  • simendan

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07288398Phase 3Dec 31, 2025Tenax Therapeutics, Inc.
NCT07262723Phase 2/Phase 3 (Phase 3)Dec 1, 2025Chittagong Medical College, Pi Research Consultancy Center, Bangladesh
NCT07105202Phase 4Sep 17, 2025Radboud University
NCT06196177Phase 4Mar 1, 2024Shandong University
NCT06387862Phase 2Feb 1, 2024Free University of Brussels
NCT05983250Phase 3Nov 30, 2023Medpace, Inc., Tenax Therapeutics, Inc.
NCT05956431Phase 4Aug 1, 2023Peking University, Shandong University
NCT05768230Phase 2/Phase 3 (Phase 3)Mar 22, 2023Huazhong University of Science and Technology
NCT05664191Phase 2Mar 1, 2023Assistance Publique - Hôpitaux de Paris, Hôpital Lariboisière, Orion Corporation
NCT05233202Phase 3Jun 1, 2022Assistance Publique - Hôpitaux de Paris
NCT05222256N/AMar 31, 2022Assiut University
NCT04970238Phase 4Oct 31, 2021Shengjing Hospital
NCT04728932Phase 3Aug 27, 2021Assistance Publique - Hôpitaux de Paris
NCT05063370Phase 2Aug 18, 2021Ain Shams University
NCT04858308Phase 3Jan 29, 2021Seoul National University, Yooyoung Pharmaceutical Co.,Ltd.
NCT04718350N/AJan 27, 2021Aretaieion University
NCT04874129Phase 1Jan 7, 2021Chonbuk National University, Yooyoung Pharmaceutical Co.,Ltd.
NCT04705337Phase 4Jan 1, 2021Cardinal Stefan Wyszyński Institute of Cardiology, Institute of Cardiology, Warsaw, Poland, John Paul II Hospital, Krakow, Medical University of Bialystok, Medical University of Lodz, Nicolaus Copernicus University, Poznan University, University of Campania Luigi Vanvitelli, University of Opole
NCT04950569Phase 4Oct 29, 2020Huazhong University of Science and Technology
NCT04599816N/AOct 17, 2020Aretaieion University
Showing 20 of 91 trials
Page 1 / 5

Organizations

Research & Development (94)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Orion CorporationFor profit22742002
Tenax Therapeutics, Inc.For profit6632014
University of GothenburgAcademic/Hospital6542002
AbbottFor profit4212002
University of Roma La SapienzaAcademic/Hospital4422005
Yooyoung Pharmaceutical Co.,Ltd.For profit4422018
Assistance Publique - Hôpitaux de ParisAcademic/Hospital3322021
Radboud UniversityAcademic/Hospital3332010
Shandong UniversityAcademic/Hospital3212017
University of HelsinkiAcademic/Hospital3012004
University of Las Palmas de Gran CanariaAcademic/Hospital3332009
University of MilanAcademic/Hospital3322011
Aretaieion UniversityAcademic/Hospital2212020
Assiut UniversityAcademic/Hospital2222019
Cairo UniversityAcademic/Hospital2122017
Chonbuk National UniversityAcademic/Hospital2012019
Huazhong University of Science and TechnologyAcademic/Hospital2222020
Kuopio University HospitalAcademic/Hospital2112005
Medical University InnsbruckAcademic/Hospital2212009
Nicolaus Copernicus UniversityAcademic/Hospital2112018
94 organizations
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