Levosimendan

also known as SIMDAX · LEVO · Simdax (manufacturer: Orion Corporation) · SIMDAX (trade mark) · SimdaxTM · Sindax

Developed for: heart failure · cardiogenic shock · diastolic heart failure · acute respiratory distress syndrome · aortic valve stenosis · infectious disease with sepsis · advanced heart failure · amyotrophic lateral sclerosis
+22 more
· cardiac valvular defect · pulmonary hypertension · ST-elevation myocardial infarction · systolic heart failure · acute kidney injury · cardiac arrest · congestive heart failure · coronary artery disorder · heart valve disorder · left ventricular failure · myocardial disorder · myocardial infarction · subarachnoid hemorrhage · symptomatic heart failure · transient ischemic attack · acute myocarditis · aorta coarctation · cardio-renal syndrome · cardiomyopathy · cardiovascular disorder · mitral valve disorder · myocardial stunning
Investigated by: Orion Corporation, Orion Pharma · Abbott · Tenax Therapeutics, Inc. · Assistance Publique - Hôpitaux de Paris · Qilu Hospital of Shandong University · Assiut University
+63 more
· Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · University of Roma La Sapienza · Azienda Ospedaliera dei Colli · Beacon Pharmaceuticals PLC · CRO TRIDE Asesores SL · Canary Foundation · Centre Hospitalier Universitaire Dijon · China International Medical Foundation · China National Center for Cardiovascular Diseases · Chittagong Medical College · Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Collegium Medicum w Bydgoszczy · Dr. Gerhard Pölzl · Emory University · Fudan University · Guangdong Provincial People's Hospital · Göteborg University · Helsinki University Central Hospital · Hospital Universitario de Canarias · Hospital Universitario de Gran Canaria Doctor Negrín · John Paul II Hospital, Krakow · Jose Luis Vazquez Martinez · Kuopio University Hospital · Ludwig Boltzmann Gesellschaft · María de los Ángeles Tena Pajuelo · Medical Research Agency, Poland · Medical University Innsbruck · Medical University of Bialystok · Medical University of Lodz · Medpace, Inc. · Military Hospital of Tunis · National Institute of Cardiology, Warsaw, Poland · Nicolaus Copernicus University · Niguarda Hospital · Ningbo No. 1 Hospital · Peking Union Medical College Hospital · Peking University Third Hospital · Pi Research and Development Center, Bangladesh · Poznan University of Medical Sciences · Pr Bruno LEVY · QBE Europe SA/NV · Renmin Hospital of Wuhan University · Sahlgrenska University Hospital · Sant Pau Research Institute · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shenzhen Second People's Hospital · Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · Tampere University Hospital · The First Affiliated Hospital of Zhengzhou University · The Second Affiliated Hospital of Harbin Medical University · Tongji Hospital · University College London Hospitals · University Hospital Brussels · University Medical Center Nijmegen · University of Aarhus · University of Opole · University of Utah · VieCuri Medical Centre · Vita-Salute San Raffaele University · Wentworth Area Health Services · West China Hospital · Yooyoung Pharmaceutical Co., Ltd. · Zhijun Sun

Trials 56

today NCT07262723 · Ph 2/3 NCT06196177 · Ph 4 NCT06387862 · Ph 2 NCT05664191 · Ph 2 NCT05956431 · Ph 4 NCT04020263 · Ph 3 NCT05768230 · Ph 2/3 NCT05233202 · Ph 3 NCT05658692 · Ph 4 NCT05222256 · not/applicable NCT04705337 · Ph 4 NCT04970238 · Ph 4 NCT04728932 · Ph 3 NCT04950569 · Ph 4 NCT04573049 · Ph 4 NCT04179604 · Ph 2/3 NCT04158674 · Ph 3 NCT04020003 · Ph 3 NCT03948178 · Ph 3 NCT03624010 · Ph 2 NCT03855579 · Ph 4 NCT03555123 · Ph 3 NCT03699215 · Ph 3 NCT03541603 · Ph 2 NCT03764722 · Ph 4 NCT03505021 · Ph 3 NCT03437226 · Ph 3 NCT03189901 · Ph 4 NCT01720030 · Ph 2/3 NCT02232399 · Ph 2 NCT02025621 · Ph 3 NCT02408003 · not/applicable NCT01721434 · Ph 2/3 NCT01301313 · Ph 2 NCT01595737 · Ph 4 NCT01290146 · Ph 3 NCT02963454 · not/applicable NCT01188369 · Ph 4 NCT00994825 · Ph 4 NCT01065194 · Ph 3 NCT01210976 · Ph 4 NCT00698763 · Ph 2 NCT00695929 · not/applicable NCT00800306 · Ph 2 NCT00549107 · Ph 2 NCT00585104 · Ph 2 NCT00166127 · Ph 3 NCT00154115 · Ph 4 NCT00130884 · Ph 2 NCT00610350 · Ph 4 NCT00093301 · Ph 2/3 NCT00130871 · Ph 2 NCT00348504 · Ph 3 NCT00219388 · Ph 4 NCT00048425 · Ph 3

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 212 trials · 1 met primary · 2 missed
Phase 2	NCT06387862	Feb → Nov 2024	left ventricular failure	University Hospital Brussels	Unknown	No outcome recorded
Phase 2	NCT05664191	Oct 2023 → Apr 2026	subarachnoid hemorrhage	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 2	NCT03624010	Apr 2019 → Apr 2023	diastolic heart failure, pulmonary hypertension, symptomatic heart failure	Tenax Therapeutics, Inc.	Completed	No outcome recorded
Phase 2	NCT03541603	Nov 2018 → Apr 2020	diastolic heart failure, pulmonary hypertension	Tenax Therapeutics, Inc.	Completed	Missed primary
Phase 2	NCT02232399	Oct 2014 → Apr 2017	congenital heart defects, multiple types	Göteborg University	Completed	Missed primary
Phase 2	NCT01301313	Feb 2011 → Feb 2012	heart failure	Jose Luis Vazquez Martinez	Terminated	No outcome recorded
Phase 2	NCT00698763	Aug 2008 → Apr 2009	transient ischemic attack	Orion Corporation, Orion Pharma	Completed	No outcome recorded
Phase 2	NCT00800306	Nov 2007 → Feb 2008	infectious disease with sepsis	University of Roma La Sapienza	Completed	Met primary
Phase 2	NCT00549107	Sep 2007 → ?	—	Ludwig Boltzmann Gesellschaft	Unknown	No outcome recorded
Phase 2	NCT00585104	Sep 2006 → Dec 2008	heart failure	University of Utah	Completed	No outcome recorded
Phase 2	NCT00130884	Mar 2005 → Mar 2006	heart failure	Orion Corporation, Orion Pharma	Completed	No outcome recorded
Phase 2	NCT00130871	Jan 2004 → Jan 2006	coronary artery disorder	Orion Corporation, Orion Pharma	Completed	No outcome recorded

Phase 2/36 trials
Phase 2/3	NCT07262723	Dec 2025 → Oct 2026 expected	heart failure	Chittagong Medical College	Not yet recruiting	No outcome recorded
Phase 2/3	NCT05768230	Mar 2023 → Dec 2025	acute respiratory distress syndrome	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Unknown	No outcome recorded
Phase 2/3	NCT04179604	Jun 2020 → Jan 2022	heart failure	María de los Ángeles Tena Pajuelo	Unknown	No outcome recorded
Phase 2/3	NCT01720030	Sep 2016 → Oct 2017	acute kidney injury	VieCuri Medical Centre	Unknown	No outcome recorded
Phase 2/3	NCT01721434	Sep 2012 → May 2016	—	University Medical Center Nijmegen	Unknown	No outcome recorded
Phase 2/3	NCT00093301	Oct 2004 → Apr 2006	cardiogenic shock, infectious disease with sepsis	Wentworth Area Health Services	Unknown	No outcome recorded
Phase 316 trials · 1 met primary · 6 missed
Phase 3	NCT04020263	Jul 2023 → Feb 2027 expected	cardiogenic shock	Pr Bruno LEVY	Recruiting	No outcome recorded
Phase 3	NCT05233202	Jan 2023 → Jan 2025	—	Assistance Publique - Hôpitaux de Paris	Unknown	No outcome recorded
Phase 3	NCT04728932	Aug 2021 → Nov 2024	cardiogenic shock	Assistance Publique - Hôpitaux de Paris	Completed	Missed primary
Phase 3	NCT04158674	Feb 2020 → Oct 2023	heart failure	Centre Hospitalier Universitaire Dijon	Terminated	No outcome recorded Stop: Business
Phase 3	NCT04020003	Jul 2019 → Dec 2021	acute respiratory distress syndrome	Shenzhen Second People's Hospital	Unknown	Missed primary
Phase 3	NCT03948178	Jun 2019 → Nov 2020	amyotrophic lateral sclerosis	Orion Corporation, Orion Pharma	Terminated	No outcome recorded
Phase 3	NCT03555123	Jan 2019 → Jan 2022	heart failure	Yooyoung Pharmaceutical Co., Ltd.	Unknown	No outcome recorded
Phase 3	NCT03699215	Nov 2018 → Apr 2020	ST-elevation myocardial infarction	Hospital Universitario de Canarias	Unknown	No outcome recorded
Phase 3	NCT03505021	Jun 2018 → Jul 2020	amyotrophic lateral sclerosis	Orion Corporation, Orion Pharma	Completed	Missed primary
Phase 3	NCT03437226	Mar 2018 → Apr 2019	heart failure	Dr. Gerhard Pölzl	Unknown	No outcome recorded
Phase 3	NCT02025621	Jul 2014 → Nov 2016	cardiac valvular defect, cardiogenic shock	Tenax Therapeutics, Inc.	Completed	Missed primary
Phase 3	NCT01290146	Feb 2011 → Jun 2015	advanced heart failure	Niguarda Hospital	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT01065194	Aug 2009 → Aug 2011	heart failure	Medical University Innsbruck	Unknown	Missed primary
Phase 3	NCT00166127	May 2005 → Jan 2007	heart failure	Emory University	Terminated	No outcome recorded
Phase 3	NCT00348504	Mar 2003 → Jun 2005	heart failure	Abbott	Completed	Missed primary
Phase 3	NCT00048425	Sep 2002 → Dec 2004	congestive heart failure	Abbott	Completed	Met primary

Phase 417 trials · 1 missed
Phase 4	NCT06196177	Mar 2024 → Jan 2025	aortic valve stenosis, heart failure	Qilu Hospital of Shandong University	Unknown	No outcome recorded
Phase 4	NCT05956431	Aug 2023 → Dec 2024	cardiac arrest	Peking University Third Hospital	Unknown	No outcome recorded
Phase 4	NCT05658692	Oct 2022 → Oct 2023	acute respiratory distress syndrome	Second Affiliated Hospital, School of Medicine, Zhejiang University	Unknown	No outcome recorded
Phase 4	NCT04705337	Dec 2021 → Feb 2024	advanced heart failure, systolic heart failure	Medical University of Bialystok	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT04970238	Oct 2021 → Jan 2023	ST-elevation myocardial infarction, heart failure	Zhijun Sun	Unknown	No outcome recorded
Phase 4	NCT04950569	Oct 2020 → Jun 2022	heart failure	Tongji Hospital	Unknown	No outcome recorded
Phase 4	NCT04573049	Sep 2020 → Apr 2022	aortic valve stenosis, cardiac rhythm disease, heart failure	China National Center for Cardiovascular Diseases	Unknown	No outcome recorded
Phase 4	NCT03855579	Mar → Sep 2019	—	Assiut University	Unknown	No outcome recorded
Phase 4	NCT03764722	Aug 2018 → Dec 2021	systolic heart failure	Collegium Medicum w Bydgoszczy	Unknown	No outcome recorded
Phase 4	NCT03189901	Jul 2017 → Dec 2021	heart failure, myocardial infarction	Qilu Hospital of Shandong University	Unknown	No outcome recorded
Phase 4	NCT01595737	Feb 2011 → Nov 2014	cardiac valvular defect	Sant Pau Research Institute	Completed	No outcome recorded
Phase 4	NCT01188369	Sep 2010 → Mar 2013	diastolic heart failure	University of Aarhus	Terminated	No outcome recorded
Phase 4	NCT00994825	Nov 2009 → May 2016	—	Vita-Salute San Raffaele University	Completed	Missed primary
Phase 4	NCT01210976	Jan 2009 → Sep 2010	heart valve disorder	Tampere University Hospital	Completed	No outcome recorded
Phase 4	NCT00154115	Mar 2005 → Dec 2008	heart failure	Kuopio University Hospital	Completed	No outcome recorded
Phase 4	NCT00610350	Jan 2005 → Feb 2007	myocardial disorder	University of Roma La Sapienza	Completed	No outcome recorded
Phase 4	NCT00219388	Nov 2002 → Apr 2005	heart failure	Orion Corporation, Orion Pharma	Completed	No outcome recorded

Phase not applicable4 trials
—	NCT05222256	Mar 2022 → Mar 2024	—	Assiut University	Completed	No outcome recorded
—	NCT02408003	Mar 2014 → May 2016	aortic valve stenosis, diastolic heart failure	Sahlgrenska University Hospital	Completed	No outcome recorded
—	NCT02963454	Jan 2011 → Feb 2018	infectious disease with sepsis	Military Hospital of Tunis	Unknown	No outcome recorded
—	NCT00695929	Jul 2008 → Sep 2009	cardiogenic shock, congenital heart disease	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Completed	No outcome recorded
Phase not stated1 trial
—	NCT02973620	—	heart failure	Tenax Therapeutics, Inc.	No longer available	No outcome recorded
Comparator or background therapy31 trials
Phase 1/2	NCT01576094 Comparator	Nov 2009 → Nov 2010	—	Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz	Completed	No outcome recorded
Phase 2	NCT05063370 Comparator	Aug → Dec 2021	heart failure	Ain Shams University	Unknown	No outcome recorded
Phase 2	NCT03557255 Comparator	Aug 2017 → Feb 2018	heart failure	National Cancer Institute, Egypt	Completed	No outcome recorded
Phase 2	NCT01120106 Comparator	Jan 2009 → Dec 2010	—	Bambino Gesù Hospital and Research Institute	Completed	No outcome recorded
Phase 3	NCT07288398 Comparator	Mar 2026 → Jun 2028 expected	pulmonary hypertension	Tenax Therapeutics, Inc.	Recruiting	No outcome recorded
Phase 3	NCT06478667 Comparator	Dec 2024 → Jan 2025	acute myocarditis	Ain Shams University	Completed	No outcome recorded
Phase 3	NCT04329624 Comparator	Oct 2020 → Nov 2023	—	Medical University of Vienna	Completed	No outcome recorded
Phase 3	NCT02133105 Comparator	Apr 2014 → May 2017	cardio-renal syndrome	Göteborg University	Completed	No outcome recorded
Phase 3	NCT02184819 Comparator	Jun 2013 → Jun 2015	left ventricular failure	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 4	NCT07105202 Comparator	Sep 2025 → Aug 2027 expected	—	Radboud University Medical Center	Recruiting	No outcome recorded
Phase 4	NCT07186062 Comparator	Jun 2022 → Jun 2024	cardio-renal syndrome	Ain Shams University	Completed	No outcome recorded
Phase 4	NCT04330755 Comparator	Feb 2021 → Mar 2023	aorta coarctation	Dalia Saad Abd-El Kader	Completed	No outcome recorded
Phase 4	NCT03576677 Comparator	Aug 2019 → Jul 2020	heart failure	Finn Gustafsson	Unknown	No outcome recorded
Phase 4	NCT01500785 Comparator	Jun → Dec 2018	myocardial stunning	Tampere University Hospital	Terminated	No outcome recorded
Phase 4	NCT02640846 Comparator	Dec 2015 → Jan 2019	cardiomyopathy, infectious disease with sepsis	Sahlgrenska University Hospital	Unknown	No outcome recorded
Phase 4	NCT02531724 Comparator	Sep 2015 → Dec 2020	acute kidney injury	Sahlgrenska University Hospital	Completed	No outcome recorded
Phase 4	NCT02012946 Comparator	Dec 2013	cardiovascular disorder	Azienda Policlinico Umberto I	Unknown	No outcome recorded
Phase 4	NCT02261948 Comparator	Sep 2012 → Sep 2014	heart failure	Centro Cardiologico Monzino	Completed	No outcome recorded
Phase 4	NCT01616069 Comparator	Feb 2012	—	Federal University of Juiz de Fora	Completed	No outcome recorded
Phase 4	NCT01022983 Comparator	Apr 2011 → Dec 2012	heart failure	Sykehuset i Vestfold HF	Withdrawn	No outcome recorded
Phase 4	NCT01318460 Comparator	Mar 2011 → Mar 2014	coronary artery disorder	AHEPA University Hospital	Completed	No outcome recorded
Phase 4	NCT01536132 Comparator	Apr 2010 → Oct 2013	heart failure	Parc de Salut Mar	Completed	No outcome recorded
Phase 4	NCT00988806 Comparator	Nov 2009 → Dec 2013	advanced heart failure	Hospital Universitario de Canarias	Unknown	No outcome recorded
Phase 4	NCT01969071 Comparator	Jul 2009 → Jan 2013	mitral valve disorder	Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital	Completed	No outcome recorded
Phase 4	NCT00324766 Comparator	Jun 2006 → Sep 2011	cardiogenic shock, heart failure, myocardial infarction	Oslo University Hospital	Completed	No outcome recorded
—	NCT07664748 Background	Jun 2026 → May 2027 expected	heart failure	Niguarda Hospital	Not yet recruiting	No outcome recorded
—	NCT04718350 Comparator	Jan 2021 → Dec 2023	heart failure, pulmonary hypertension	Aretaieion University Hospital	Completed	No outcome recorded
—	NCT04599816 Comparator	Oct 2020 → Oct 2022	heart failure, pulmonary hypertension	Aretaieion University Hospital	Completed	No outcome recorded
—	NCT03022877 Comparator	Jun 2017 → Dec 2018	myocardial infarction	RWTH Aachen University	Withdrawn	No outcome recorded
—	NCT01101620 Comparator	Apr → Sep 2010	—	University Medical Center Nijmegen	Completed	No outcome recorded
—	NCT01221116 Comparator	Jan 2003 → Dec 2008	heart failure	Ullevaal University Hospital	Terminated	No outcome recorded

News releases announcing trial results or a regulatory action · 27

Date	Issuer	Release
2026-08-29	Tenax Therapeutics, Inc.	Results Tenax Therapeutics Announces Presentation of Phase 3 LEVEL Results in Late-Breaking Scientific Sessions at ESC Congress 2026 tenaxthera.com ↗ Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”) today announced that additional results from the Phase 3 LEVEL clinical trial evaluating TNX-103 (oral levosimendan) in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) were presented in a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany.
2026-08-10	Orion Corporation, Orion Pharma	Results Orion’s license partner Tenax Therapeutics’ Phase 3 LEVEL trial of oral levosimendan in pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) did not reach its primary endpoint orionpharma.com ↗ Oral levosimendan was generally safe and well tolerated, with serious adverse events and adjudicated clinical worsening events balanced across treatment arms.
2026-08-10	Tenax Therapeutics, Inc.	Results Tenax Therapeutics Announces Topline Results from Phase 3 LEVEL Clinical Trial of TNX-103 in Patients with PH-HFpEF tenaxthera.com ↗
2025-03-05	Tenax Therapeutics, Inc.	Regulatory Tenax Therapeutics Expands Phase 3 LEVEL Program, Advancing Two TNX-103 (Oral Levosimendan) Registrational Studies for the Treatment of PH-HFpEF tenaxthera.com ↗ Amendment to Enlarge Phase 3 LEVEL Study, Increasing Statistical Powering, Accepted by FDA, Expected to be Fully Enrolled Around Year End 2025
2023-11-13	Tenax Therapeutics, Inc.	Regulatory Tenax Therapeutics Announces FDA Clearance of IND for TNX-103 (oral levosimendan) for the Treatment of Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF), Initiation of Phase 3 sites expected 2023 tenaxthera.com ↗ the U.S. Food and Drug Administration (FDA) has reviewed and cleared the Company’s Investigational New Drug (IND) Application for TNX-103 (oral levosimendan) for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF)
2022-10-10	Tenax Therapeutics, Inc.	Results Positive Data Presented at HFSA Annual Meeting Demonstrate Effects of Oral Levosimendan in Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗
2021-08-12	Tenax Therapeutics, Inc.	Results Tenax Announces New Publication Highlighting Novel Levosimendan Mechanism of Action in Pulmonary Hypertension Patients with Heart Failure and Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗ Their analysis found that the reductions in pulmonary wedge pressure (PCWP) and central venous pressure (CVP) were independent of any inotropic effect of the drug.
2021-04-09	Tenax Therapeutics, Inc.	Results Tenax Announces Publication Titled "Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF: Results of the Randomized Placebo-Controlled HELP Trial " tenaxthera.com ↗ Levosimendan produced a significant improvement in 6-minute walk distance and is the only therapy to produce such a result in a randomized, double-blind, placebo-controlled trial of PH-HFpEF patients
2020-11-10	Tenax Therapeutics, Inc.	Results Tenax Therapeutics Announces Presentation of 24-Hour HELP Study Results at the American Heart Association Scientific Sessions 2020 tenaxthera.com ↗ The 24-hour HELP Study results being presented at AHA include data from a total of 44 patients, of which 36 (~85%) were determined to be responders.
2020-07-28	Orion Corporation, Orion Pharma	Results Orion’s phase 3 REFALS trial evaluating the efficacy of oral levosimendan in treatment of ALS patients did not reach its pre-specified endpoints orionpharma.com ↗ These pre-specified endpoints were not met in the trial.
2020-06-02	Tenax Therapeutics, Inc.	Results Tenax Therapeutics Reports Positive Results from Phase 2 Trial of Levosimendan in Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗ Levosimendan also demonstrated a statistically significant improvement in 6-minute walk distance (6MWD) as compared to placebo (p=0.0329).
2020-01-13	Tenax Therapeutics, Inc.	Results Tenax Therapeutics Provides Update on Phase 2 Pulmonary Hypertension Clinical Trial tenaxthera.com ↗ 24 of 28 patients, approximately 86%, achieved this predefined responder criterion.
2018-08-28	Tenax Therapeutics, Inc.	Results Tenax Therapeutics Announces New Clinical Study Publication Results Indicate Levosimendan Offers Renal Protective Benefits to Heart Failure Patients tenaxthera.com ↗ The results indicate that levosimendan offers unique renal protective benefits to patients who have heart failure and coexisting impairment of their kidney function.
2018-03-01	Tenax Therapeutics, Inc.	Results Tenax Therapeutics Announces New Scientific Publication of Preclinical Data Provides Additional Evidence of Levosimendan Treatment Effects in Pulmonary Hypertension tenaxthera.com ↗ Tenax Therapeutics, Inc. (Nasdaq: TENX) today announced the publication of a positive preclinical study of levosimendan conducted by Hansen et al in the March 1, 2018, issue of Pulmonary Circulation.
2017-07-28	Tenax Therapeutics, Inc.	Regulatory Tenax Therapeutics Provides Regulatory Update on Levosimendan tenaxthera.com ↗ After a review of further analyses, the FDA has requested an additional clinical trial.
2017-05-16	Tenax Therapeutics, Inc.	Results Tenax Meets with FDA to Discuss Positive Mortality Data and Potential Levosimendan NDA Submission tenaxthera.com ↗ In this large prespecified subgroup of Isolated CABG patients enrolled in the LEVO-CTS trial, levosimendan treated patients benefited from a highly significant 73% relative risk reduction in all-cause mortality at Day 90, 2.1% levosimendan vs 7.9% placebo treated patients, (p=0.0016).
2017-01-31	Tenax Therapeutics, Inc.	Results Tenax Therapeutics Announces Top-Line Results From Phase 3 LEVO-CTS Trial in Cardiac Surgery tenaxthera.com ↗ However, the study demonstrated statistically significant reductions in two of three secondary endpoints including reduction in low cardiac output syndrome (LCOS) and a reduction in postoperative use of secondary inotropes.
2016-10-05	Tenax Therapeutics, Inc.	Results Tenax Therapeutics Provides Clinical Update for Lead Candidate Levosimendan tenaxthera.com ↗ Imperial College presents data from LeoPARDS trial in septic shock at ESICM Annual Congress showing that treatment arm did not meet primary endpoint
2015-07-01	Tenax Therapeutics, Inc.	Results Tenax Therapeutics Spotlights Academic Publication on Levosimendan in Cardiac Surgery tenaxthera.com ↗ Meta-analysis reports that use of levosimendan reduces mortality in adult cardiac surgery patients with left ventricular dysfunction
2015-06-16	Tenax Therapeutics, Inc.	Results Tenax Therapeutics Highlights New Scientific Publication Regarding the Potential Mortality Benefits of Levosimendan in Septic Shock Patients tenaxthera.com ↗ Recently-published meta-analysis details mortality reduction in severe sepsis and septic shock patients compared to standard inotropic therapy
2006-06-06	Orion Corporation, Orion Pharma	Results Results of PERSIST study with oral levosimendan orionpharma.com ↗ The study results are not sufficient for starting Phase 3 clinical trials.
2005-11-16	Orion Corporation, Orion Pharma	Results Abbott reports levosimendan (Simdax®) results from large mortality trial in patients with acute decompensated heart failure orionpharma.com ↗ Although the study did not discern a difference in long-term outcome between levosimendan and dobutamine, earlier timepoints, closer to actual drug administration, appear to favor levosimendan.
2005-11-14	Orion Corporation, Orion Pharma	Results Abbott reports improved clinical course with Orion's levosimendan (Simdax®) when added to standard therapy in acute decompensated heart failure trial orionpharma.com ↗ More patients improved, and fewer patients worsened, when treated with levosimendan.
2003-10-02	Orion Corporation, Orion Pharma	Regulatory Orion's Simdax will wait for the final study results in Germany orionpharma.com ↗ After the careful evaluation of these pilot results, BfArM, however, decided to wait for the final results of the US study.
2003-07-10	Orion Corporation, Orion Pharma	Regulatory Review in Germany for Orion Pharma's levosimendan orionpharma.com ↗ The research documentation concerning Orion Corporation Orion Pharma's levosimendan has been taken for review by the German drug authority, in the light of the recent Phase III study results, which Orion Pharma published in June.
2001-04-11	Orion Corporation, Orion Pharma	Regulatory Orion Pharma's heart failure drug Simdax to be approved in eight european countries orionpharma.com ↗ Orion Corporation Orion Pharma has received favourable mutual recognition decisions concerning heart failure medication Simdax (levosimendan) in eight European countries: Finland, Spain, Italy, Island, Greece, Luxemburg, Norway, and Portugal.
2000-09-26	Orion Corporation, Orion Pharma	Regulatory Orion launching proprietary medicine again: Simdax (Levosimendan) approved in Sweden for severe heart failure orionpharma.com ↗

All press releases naming this drug 61 releases

Date	Issuer	Release
2026-08-29	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces Presentation of Phase 3 LEVEL Results in Late-Breaking Scientific Sessions at ESC Congress 2026 tenaxthera.com ↗
2026-08-10	Orion Corporation, Orion Pharma	Orion’s license partner Tenax Therapeutics’ Phase 3 LEVEL trial of oral levosimendan in pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) did not reach its primary endpoint orionpharma.com ↗
2026-08-10	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces Topline Results from Phase 3 LEVEL Clinical Trial of TNX-103 in Patients with PH-HFpEF tenaxthera.com ↗
2025-11-06	Tenax Therapeutics, Inc.	Tenax Therapeutics to Host Virtual KOL Call to Discuss TNX-103 (Oral Levosimendan) for the Treatment of PH-HFpEF tenaxthera.com ↗
2025-09-16	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces European Patent Office Intention to Grant Patent Covering Use of Levosimendan in PH-HFpEF tenaxthera.com ↗
2025-03-05	Tenax Therapeutics, Inc.	Tenax Therapeutics Expands Phase 3 LEVEL Program, Advancing Two TNX-103 (Oral Levosimendan) Registrational Studies for the Treatment of PH-HFpEF tenaxthera.com ↗
2024-08-12	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces Closing of $100 Million Private Placement and Plans to Accelerate the Oral Levosimendan Phase 3 Program tenaxthera.com ↗
2024-04-30	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces New U.S. Patent Covering the Use of Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗
2024-04-09	Tenax Therapeutics, Inc.	Tenax Therapeutics to Host KOL Event: "LEVEL Setting: the Scientific Rationale for Levosimendan as a Potential First Treatment for PH-HFpEF, and the Ongoing Phase 3 LEVEL Study" tenaxthera.com ↗
2024-02-29	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces Oral Presentation of Levosimendan for the Treatment of PH-HFpEF at THT 2024 tenaxthera.com ↗
2024-02-20	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces Global License Amendment that Significantly Expands Rights to Levosimendan tenaxthera.com ↗
2024-02-07	Tenax Therapeutics, Inc.	Tenax Therapeutics Enrolls First Patient in Phase 3 LEVEL Study Evaluating TNX-103 (Oral Levosimendan) for the Treatment of Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗
2024-02-06	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces USPTO Grants Notice of Allowance for U.S. Patent Application, Significantly Broadening IP Protection for Use of Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗
2023-11-13	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces FDA Clearance of IND for TNX-103 (oral levosimendan) for the Treatment of Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF), Initiation of Phase 3 sites expected 2023 tenaxthera.com ↗
2023-07-19	Tenax Therapeutics, Inc.	Tenax Therapeutics Issued U.S. Patent for Oral Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗
2023-05-31	Tenax Therapeutics, Inc.	Tenax Therapeutics Achieves Major Milestone as USPTO Grants Notice of Allowance for U.S. Patent Application Covering Use of Oral Levosimendan (TNX-103) in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗
2023-03-22	Tenax Therapeutics, Inc.	Tenax Announces Issuance of U.S. Patent Covering Use of IV Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗
2023-02-01	Tenax Therapeutics, Inc.	Tenax Granted Notice of Allowance for U.S. Patent Application Covering Use of IV Levosimendan in Pulmonary Hypertension with Heart Failure and Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗
2022-10-10	Tenax Therapeutics, Inc.	Positive Data Presented at HFSA Annual Meeting Demonstrate Effects of Oral Levosimendan in Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗
2022-01-12	Tenax Therapeutics, Inc.	Tenax Therapeutics Granted U.S. Patent for the Subcutaneous Use of Levosimendan (TNX-102) tenaxthera.com ↗
2021-08-12	Tenax Therapeutics, Inc.	Tenax Announces New Publication Highlighting Novel Levosimendan Mechanism of Action in Pulmonary Hypertension Patients with Heart Failure and Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗
2021-08-05	Tenax Therapeutics, Inc.	Tenax Therapeutics Announced KOL Webinar on Levosimendan for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗
2021-04-09	Tenax Therapeutics, Inc.	Tenax Announces Publication Titled "Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF: Results of the Randomized Placebo-Controlled HELP Trial " tenaxthera.com ↗
2020-11-10	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces Presentation of 24-Hour HELP Study Results at the American Heart Association Scientific Sessions 2020 tenaxthera.com ↗
2020-10-15	Tenax Therapeutics, Inc.	Tenax Therapeutics Gains North American Rights to Oral Levosimendan through Expanded License Agreement with Orion Corporation tenaxthera.com ↗
2020-07-28	Orion Corporation, Orion Pharma	Orion’s phase 3 REFALS trial evaluating the efficacy of oral levosimendan in treatment of ALS patients did not reach its pre-specified endpoints orionpharma.com ↗
2020-06-02	Tenax Therapeutics, Inc.	Tenax Therapeutics Reports Positive Results from Phase 2 Trial of Levosimendan in Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗
2020-04-09	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces Last Patient Completes Final Visit in its Phase 2 "HELP Study" of Levosimendan for Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction tenaxthera.com ↗
2020-01-13	Tenax Therapeutics, Inc.	Tenax Therapeutics Provides Update on Phase 2 Pulmonary Hypertension Clinical Trial tenaxthera.com ↗
2019-12-09	Orion Corporation, Orion Pharma	Orion presented data on oral levosimendan at the 30th International Symposium on ALS/MND orionpharma.com ↗
2019-12-02	Orion Corporation, Orion Pharma	Orion to present four posters on oral levosimendan in patients with ALS at the 30th International Symposium on ALS/MND orionpharma.com ↗
2019-07-15	Orion Corporation, Orion Pharma	Orion completes enrollment in the REFALS Phase 3 trial studying the effect of oral Levosimendan in patients with amyotrophic lateral sclerosis (ALS) orionpharma.com ↗
2019-02-04	Orion Corporation, Orion Pharma	Orion intents to start an open label extension study to the REFALS phase 3 trial studying the effect of oral levosimendan in patients with ALS orionpharma.com ↗
2018-08-28	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces New Clinical Study Publication Results Indicate Levosimendan Offers Renal Protective Benefits to Heart Failure Patients tenaxthera.com ↗
2018-06-01	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces Study Design for Phase 2 Trial of Levosimendan in PH-HFpEF Patients tenaxthera.com ↗
2018-04-04	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces Results of Pre-IND Meeting with FDA for Phase 2 Study of Levosimendan in PH-HFpEF Patients tenaxthera.com ↗
2018-03-01	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces New Scientific Publication of Preclinical Data Provides Additional Evidence of Levosimendan Treatment Effects in Pulmonary Hypertension tenaxthera.com ↗
2018-01-16	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces Plan to Develop Levosimendan for a Pulmonary Hypertension Indication with No FDA Approved Therapies tenaxthera.com ↗
2017-07-28	Tenax Therapeutics, Inc.	Tenax Therapeutics Provides Regulatory Update on Levosimendan tenaxthera.com ↗
2017-05-16	Tenax Therapeutics, Inc.	Tenax Meets with FDA to Discuss Positive Mortality Data and Potential Levosimendan NDA Submission tenaxthera.com ↗
2017-01-31	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces Top-Line Results From Phase 3 LEVO-CTS Trial in Cardiac Surgery tenaxthera.com ↗
2016-10-05	Tenax Therapeutics, Inc.	Tenax Therapeutics Provides Clinical Update for Lead Candidate Levosimendan tenaxthera.com ↗
2015-07-01	Tenax Therapeutics, Inc.	Tenax Therapeutics Spotlights Academic Publication on Levosimendan in Cardiac Surgery tenaxthera.com ↗
2015-06-16	Tenax Therapeutics, Inc.	Tenax Therapeutics Highlights New Scientific Publication Regarding the Potential Mortality Benefits of Levosimendan in Septic Shock Patients tenaxthera.com ↗
2015-03-05	Tenax Therapeutics, Inc.	Tenax Therapeutics Highlights Recent Scientific Publications on Levosimendan tenaxthera.com ↗
2014-09-22	Tenax Therapeutics, Inc.	Tenax Therapeutics Announces First Patients Enrolled in Phase 3 LEVO-CTS Clinical Trial of Levosimendan tenaxthera.com ↗
2013-10-22	Orion Corporation, Orion Pharma	Orion licenses the levosimendan injection rights in the USA and Canada to Phyxius orionpharma.com ↗
2009-05-06	Orion Corporation, Orion Pharma	Orion reacquires rights for i.v. levosimendan (Simdax®) orionpharma.com ↗
2007-04-25	Orion Corporation, Orion Pharma	Orion's partner discontinues development of levosimendan (Simdax) in the US orionpharma.com ↗
2007-02-06	Orion Corporation, Orion Pharma	Orion updates progress with Simdax (i.v. levosimendan): orionpharma.com ↗
2006-06-06	Orion Corporation, Orion Pharma	Results of PERSIST study with oral levosimendan orionpharma.com ↗
2006-05-18	Orion Corporation, Orion Pharma	Orion update on Simdax: Additional Phase 3 study under consideration orionpharma.com ↗
2006-01-26	Orion Corporation, Orion Pharma	Orion updates information about Abbott's progress with Simdax orionpharma.com ↗
2005-12-15	Orion Corporation, Orion Pharma	Interim statement of progress with Simdax according to a confirmation by Abbott today orionpharma.com ↗
2005-11-16	Orion Corporation, Orion Pharma	Abbott reports levosimendan (Simdax®) results from large mortality trial in patients with acute decompensated heart failure orionpharma.com ↗
2005-11-14	Orion Corporation, Orion Pharma	Abbott reports improved clinical course with Orion's levosimendan (Simdax®) when added to standard therapy in acute decompensated heart failure trial orionpharma.com ↗
2004-04-15	Orion Corporation, Orion Pharma	Orion and Abbott expand collaboration for injectable levosimendan orionpharma.com ↗
2003-10-02	Orion Corporation, Orion Pharma	Orion's Simdax will wait for the final study results in Germany orionpharma.com ↗
2003-07-10	Orion Corporation, Orion Pharma	Review in Germany for Orion Pharma's levosimendan orionpharma.com ↗
2001-04-11	Orion Corporation, Orion Pharma	Orion Pharma's heart failure drug Simdax to be approved in eight european countries orionpharma.com ↗
2000-09-26	Orion Corporation, Orion Pharma	Orion launching proprietary medicine again: Simdax (Levosimendan) approved in Sweden for severe heart failure orionpharma.com ↗

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 89 sources stand behind the page.

Field	Value	Cited text
Known as	Levosimendan	“Levosimendan, an inotropic agent, enhances cardiac contractility through calcium sensitization with minimal oxygen demand and, in turn, decreases the risk of arrhythmia.” NCT06478667 ↗ 85 “Effects of Levosimendan on Cardiac Function After TAVR in Patients With Heart Failure” NCT06196177 ↗ “study drug, levosimendan (given orally)” NCT07288398 ↗ “Levosimendan” NCT05658692 ↗ NCT04573049 ↗ NCT04020263 ↗ NCT01301313 ↗ NCT04329624 ↗ NCT02531724 ↗ NCT07105202 ↗ NCT00154115 ↗ Show 75 more sources
Known as	LEVO	“Levosimendan (LEVO) is a novel class IND developed for the treatment of heart failure.” NCT01576094 ↗
Known as	SIMDAX	“Levosimendan (SIMDAX) is a new calcium sensitizer which increases the myocardial contractility without particular promotion of the intracellular calcium accumulation.” NCT01318460 ↗ 1 NCT03555123 ↗
Known as	Simdax (manufacturer: Orion Corporation)	“Simdax (manufacturer: Orion Corporation)” NCT01500785 ↗
Known as	SIMDAX (trade mark)	“SIMDAX (trade mark)” NCT01536132 ↗
Known as	SimdaxTM	“Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer which has been shown to have beneficial hemodynamic effects in patients with decompensated...” NCT00585104 ↗
Known as	Sindax	“The Spanish Randomized Clinical Trial on Levosimendan (brand name: Sindax) (SPARTANS) aims to demonstrate the effectiveness of the preoperative use of Levosimendan in reducing...” NCT04179604 ↗
Action	Activate	“mediated via the opening of sarcolemmal and mitochondrial ATP-sensitive potassium channels” PMID 19151048 ↗ Feb 2009
Modality	Other / unclassified	“Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer” NCT00585104 ↗
Route	Intravenous	“given intravenously” PMID 24621834 ↗ Apr 2013