Levosimendan

Overview

Levosimendan increases calcium sensitivity to myocytes by binding to troponin C in a calcium dependent manner. This increases contractility without raising calcium levels. It also relaxes vascular smooth muscle by opening adenosine triphosphate sensitive potassium channels. Levosimendan is used to manage acutely decompensated congestive heart failure.

Indication

For short term treatment of acutely decompensated severe chronic heart failure (CHF). Also being investigated for use/treatment in heart disease.

Associated Conditions

Acute Decompensated Heart Failure (ADHF)
Acute Decompensation of Chronic Heart Failure
Acute Heart Failure (AHF)
Chronic Heart Failure (CHF)
Acute post-surgical heart failure
Acute, chronic Decompensated Heart Failure
Heart failure post-myocardial infarction
Severe Decompensated Chronic Heart Failure

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Pharmacokinetics of Inhaled Levosimendan	2024/04/29	NCT06387862	Phase 2	Recruiting	Universitair Ziekenhuis Brussel
Interest of Levosimendan Preconditioning for Cardiac Surgery Under CEC in Heart Failure Patients With Impaired Ejection Fraction	2023/09/01	NCT06021587	N/A	Recruiting	Central Hospital, Nancy, France
LEVosimendan to Improve Exercise Limitation in Patients with PH-HFpEF	2023/08/09	NCT05983250	Phase 3	Recruiting	Tenax Therapeutics, Inc.
RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest	2023/07/21	NCT05956431	Phase 4	Not yet recruiting	Peking University Third Hospital
Using TEE to Evaluate the Effect of Levosimendan on Patients With ARDS Associated With RVD During MV	2023/03/14	NCT05768230	Phase 2	Not yet recruiting	Wuhan Union Hospital, China
Efficacy and Clinical Outcomes of Levosimendan in E-CPR	2023/02/16	NCT05730907	N/A	Recruiting	Hamad Medical Corporation
Impact of Levosimendan Preconditioning on Critical Care and In-hospital Lengths of Stay After Cardiac Surgery With Bypass Surgery	2023/01/17	NCT05685537	N/A	Recruiting	Central Hospital, Nancy, France
Levosimendan as Treatment of Aneurysmal SubArachnoid Haemorrhage	2022/12/23	NCT05664191	Phase 2	Recruiting	Assistance Publique - Hôpitaux de Paris
Levosimendan Versus Placebo Before Tricuspid Valve Surgery in Patients With Right Ventricular Dysfunction	2022/02/10	NCT05233202	Phase 3	Recruiting	Assistance Publique - Hôpitaux de Paris
Comparison Between Levosimendan and Adrenaline in CABG Patients	2022/02/03	NCT05222256	Not Applicable	UNKNOWN	Assiut University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Levosimendan Injection	海南合瑞制药股份有限公司	国药准字H20249838	化学药品	注射剂	12/25/2024
Levosimendan Injection	ORION CORPORATION	国药准字HJ20200028	化学药品	注射剂	8/12/2020
Levosimendan Injection	北京民康百草医药科技有限公司	国药准字H20244530	化学药品	注射剂	7/30/2024
Levosimendan Injection	成都地奥九泓制药厂	国药准字H20243548	化学药品	注射剂	4/17/2024
Levosimendan Injection	扬子江药业集团四川海蓉药业有限公司	国药准字H20233743	化学药品	注射剂	6/21/2023
Levosimendan Injection	上海旭东海普药业有限公司	国药准字H20234115	化学药品	注射剂	9/5/2023
Levosimendan Injection	成都圣诺生物制药有限公司	国药准字H20110104	化学药品	注射剂	5/10/2021
Levosimendan Injection	山西德元堂药业有限公司	国药准字H20244375	化学药品	注射剂	7/9/2024
Levosimendan Injection	海南倍特药业有限公司	国药准字H20244000	化学药品	注射剂	6/11/2024
Levosimendan Injection	成都新恒创药业有限公司	国药准字H20243485	化学药品	注射剂	4/11/2024

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

FDA Endorses Expanded Phase 3 Program for Tenax's Novel PH-HFpEF Treatment TNX-103

4 months ago

Tenax Therapeutics receives FDA approval to expand its ongoing LEVEL study to 230 patients, increasing statistical power to over 95% for their oral levosimendan (TNX-103) trial in PH-HFpEF treatment.

Tenax Therapeutics Appoints Gillian Andor as VP of Clinical Operations to Bolster Phase 3 Program

6 months ago

• Tenax Therapeutics has appointed Gillian Andor as Vice President of Clinical Operations to support its Phase 3 program for oral levosimendan (TNX-103). • Ms. Andor brings over 20 years of experience in clinical operations, including NDA submissions and approvals, to accelerate the Phase 3 LEVEL study. • Her expertise will be crucial as Tenax Therapeutics advances oral levosimendan for pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). • The appointment signifies Tenax's commitment to strengthening its clinical development capabilities as it prepares for potential global regulatory filings.

High-Dose Diuretics and Levosimendan Show Promise in Acute Heart Failure with Renal Dysfunction

6 months ago

A network meta-analysis of 13 studies involving 21,745 patients suggests high-dose diuretics (HDD) are most effective in reducing NT-proBNP levels in acute heart failure (AHF) patients with renal dysfunction.

Tenax Therapeutics' Levosimendan Shows Promise in Pulmonary Hypertension with Heart Failure

9 months ago

Tenax Therapeutics is developing levosimendan for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF), a condition affecting over 2 million U.S. patients.

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