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Chemistry

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Also known as: 141505-33-1, Simdax, (r)-simendan, (-)-or-1259, Or-1259, Simendan, (r)-
Molecular Formula
C14H12N6O
Molecular Weight
280.28  g/mol
InChI Key
WHXMKTBCFHIYNQ-SECBINFHSA-N
FDA UNII
C6T4514L4E

Levosimendan
A hydrazone and pyridazine derivative; the levo-form is a phosphodiesterase III inhibitor, calcium-sensitizing agent, and inotropic agent that is used in the treatment of HEART FAILURE.
1 2D Structure

Levosimendan

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[[4-[(4R)-4-methyl-6-oxo-4,5-dihydro-1H-pyridazin-3-yl]phenyl]hydrazinylidene]propanedinitrile
2.1.2 InChI
InChI=1S/C14H12N6O/c1-9-6-13(21)19-20-14(9)10-2-4-11(5-3-10)17-18-12(7-15)8-16/h2-5,9,17H,6H2,1H3,(H,19,21)/t9-/m1/s1
2.1.3 InChI Key
WHXMKTBCFHIYNQ-SECBINFHSA-N
2.1.4 Canonical SMILES
CC1CC(=O)NN=C1C2=CC=C(C=C2)NN=C(C#N)C#N
2.1.5 Isomeric SMILES
C[C@@H]1CC(=O)NN=C1C2=CC=C(C=C2)NN=C(C#N)C#N
2.2 Other Identifiers
2.2.1 UNII
C6T4514L4E
2.3 Synonyms
2.3.1 MeSH Synonyms

1. ((4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazono)propanedinitrile

2. Dextrosimendan

3. Or 1259

4. Or 1855

5. Or-1259

6. Or-1855

7. Simadax

8. Simendan

2.3.2 Depositor-Supplied Synonyms

1. 141505-33-1

2. Simdax

3. (r)-simendan

4. (-)-or-1259

5. Or-1259

6. Simendan, (r)-

7. Chebi:50567

8. 2-[[4-[(4r)-4-methyl-6-oxo-4,5-dihydro-1h-pyridazin-3-yl]phenyl]hydrazinylidene]propanedinitrile

9. Nsc-759644

10. Levosimedan

11. C6t4514l4e

12. Or1259

13. (r)-((4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazono) Propanedintrile

14. (r)-n-(4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)phenyl)carbonohydrazonoyl Dicyanide

15. Levosimendan [inn]

16. Dsstox_cid_26445

17. Dsstox_rid_81620

18. Mesoxalonitrile (p-((r)-1,4,5,6-tetrahydro-4-methyl-6-oxo-pyridazinyl)phenyl)hydrazone

19. Dsstox_gsid_46445

20. Levosimendanum

21. Smr002529692

22. Simdax (tn)

23. Cas-141505-33-1

24. Levosimendan (usan/inn)

25. Levosimendan [usan:inn]

26. Or 1259

27. Unii-c6t4514l4e

28. ((4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazono)propanedinitrile

29. Levosimendan- Bio-x

30. Levosimendan [mi]

31. Levosimendan [usan]

32. Mesoxalonitrile (-)-(p((r)-1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazone

33. Schembl83243

34. Levosimendan [mart.]

35. Mls003899227

36. Mls006010741

37. Levosimendan [who-dd]

38. Chembl2051955

39. Dtxsid9046445

40. Levosimendan, >=98% (hplc)

41. Hms3264g03

42. Hms3884n17

43. Kuc109648n

44. Pharmakon1600-01502356

45. Act02710

46. Bcp07048

47. Zinc3915645

48. Tox21_112191

49. Tox21_113768

50. Bdbm50469700

51. Mfcd00867135

52. Nsc759644

53. S2446

54. Akos015895214

55. Tox21_112191_1

56. Ac-1752

57. Am84381

58. Ccg-213048

59. Db00922

60. Ds-8918

61. Nsc 759644

62. ({4-[(4r)-4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl]phenyl}hydrazono)propanedintrile

63. 2-[[4-[(4r)-4-methyl-6-oxo-4,5-dihydro-1h-pyridazin-3-yl]phenyl]hydrazono]propanedinitrile

64. Ksc-210-010

65. Ncgc00253641-01

66. Ncgc00263564-01

67. Ncgc00263564-02

68. Bm164625

69. Hy-14286

70. L0320

71. Sw219172-1

72. A11874

73. D04720

74. N12889

75. Ab01562970_01

76. Ab01562970_02

77. 741l087

78. A807767

79. Q162541

80. Sr-01000931342

81. Sr-01000931342-2

82. 1-beta-d-ribofuranose-1h-1,2,4-triazole-3-methylcarbonate

83. (r)-(4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)phenyl)carbonohydrazonoyl Dicyanide

84. (r)-n-(4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)phenyl)carbonohydrazonoyldicyanide

85. 1-cyano-n-{4-[(4r)-4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl]phenyl}methanecarbohydrazonoyl Cyanide

86. 2-(2-(4-((4r)-1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazinylidene)propanedinitrile

87. Mesoxalonitrile (-)-(p((r)-1,4,5,6-tetrahydro-4-methyl-6- Oxo-3-pyridazinyl)phenyl)hydrazone

88. Propanedinitrile, ((4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazono)-, (r)-

89. Propanedinitrile, 2-(2-(4-((4r)-1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazinylidene)-

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 280.28 g/mol
Molecular Formula C14H12N6O
XLogP32.3
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count6
Rotatable Bond Count3
Exact Mass280.10725903 g/mol
Monoisotopic Mass280.10725903 g/mol
Topological Polar Surface Area113 Ų
Heavy Atom Count21
Formal Charge0
Complexity549
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

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


5 Pharmacology and Biochemistry
5.1 Pharmacology

Levosimendan is a new Ca2+-sensitizing inotropic agent. Ca2+ sensitizers represent a new class of inotropic agents, which overcome the disadvantages associated with currently available inotropic agents in as they are not associated with an increased risk of arrhythmias, cell injury and death due to Ca2+ overload in myocardial cells; they do not increase the activation energy; and they have the potential to reverse contractile dysfunction under pathophysiologic conditions, such as acidosis or myocardial stunning. Levosimendan has not been approved for use in the U.S. or Canada.


5.2 MeSH Pharmacological Classification

Vasodilator Agents

Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)


Cardiotonic Agents

Agents that have a strengthening effect on the heart or that can increase cardiac output. They may be CARDIAC GLYCOSIDES; SYMPATHOMIMETICS; or other drugs. They are used after MYOCARDIAL INFARCT; CARDIAC SURGICAL PROCEDURES; in SHOCK; or in congestive heart failure (HEART FAILURE). (See all compounds classified as Cardiotonic Agents.)


Phosphodiesterase 3 Inhibitors

Compounds that specifically inhibit PHOSPHODIESTERASE 3. (See all compounds classified as Phosphodiesterase 3 Inhibitors.)


5.3 ATC Code

C - Cardiovascular system

C01 - Cardiac therapy

C01C - Cardiac stimulants excl. cardiac glycosides

C01CX - Other cardiac stimulants

C01CX08 - Levosimendan


5.4 Absorption, Distribution and Excretion

Absorption

The bioavailability of oral levosimendan is 85 ± 6% in healthy volunteers and 84 ± 4% in patients.


5.5 Metabolism/Metabolites

Complete metabolism, with some active metabolites (OR-1855 and OR-1896) possibly extending the drug's haemodynamic effects.


5.6 Biological Half-Life

Eliminination half-life is approximately 1 hour.


5.7 Mechanism of Action

Levosimendan appears to increase myofilament calcium sensitivity by binding to cardiac troponin C in a calcium-dependent manner. This stabilizes the calcium-induced conformational change of troponin C, thereby (1) changing actin-myosin cross-bridge kinetics apparently without increasing the cycling rate of the cross-bridges or myocardial ATP consumption, (2) increasing the effects of calcium on cardiac myofilaments during systole and (3) improving contraction at low energy cost (inotropic effect). Calcium concentration and, therefore, sensitization decline during diastole, allowing normal or improved diastolic relaxation. Levosimendan also leads to vasodilation through the opening of ATP-sensitive potassium channels. By these inotropic and vasodilatory actions, levosimendan increases cardiac output without increasing myocardial oxygen demand. Levosimendan also has a selective phosphodiesterase (PDE)-III inhibitory action that may contribute to the inotropic effect of this compound under certain experimental conditions. It has been reported that levosimendan may act preferentially as a Ca2+ sensitizer at lower concentrations, whereas at higher concentrations its action as a PDE-III inhibitor becomes more prominent in experimental animals and humans.


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Levosimendan IH

Date of Issue : 2025-09-26

Valid Till : 2028-07-02

Written Confirmation Number : WC-0226

Address of the Firm : D-24 & D-24/1, M.I.D.C., Kurkumbh, Taluka: Daund, District. Pune -413802, Mahara...

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Date of Issue : 2022-07-28

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Written Confirmation Number : WC-0227n

Address of the Firm : Plot No. J-73, MIDC, Tarapur, Boisar, Dist-Palghar 401506, Maharashtra, India

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About the Company : Beijing Fukangren Biopharmaceutical Technology Co., Ltd. started its drug R&D service in 1999 and is the CRO company with the longest continuous service time in China. Fukangren no...

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D-4, NEELKANTH BUSINESS,P ARK CO-OP PREMISES SOCIETY LTD., NATHANI ROAD VIDHYA VIHAR WEST,MAHA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1662057000,"product":"LEVOSIMENDAN IH API BATCH NO: LSM\/22001","address":"CAMUS HOUSE, 29-B, SURAJ NAGAR EAST, CIVIL LINES,","city":"JAIPUR, RAJASTHAN.","supplier":"CAMUS PHARMA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"PSK PHARMA LTD","customerCountry":"RUSSIA","quantity":"0.03","actualQuantity":"0.033","unit":"KGS","unitRateFc":"547000","totalValueFC":"17494.2","currency":"USD","unitRateINR":42484848.484848484,"date":"02-Sep-2022","totalValueINR":"1402000","totalValueInUsd":"17494.2","indian_port":"BOMBAY AIR","hs_no":"29334900","bill_no":"3922250","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"CAMUS HOUSE, 29-B, SURAJ NAGAR EAST, CIVIL LINES,, JAIPUR, RAJASTHAN.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709577000,"product":"PHARMA.RAW MTRL,ACTIVE PHARMA INGREDIENT,PAC.DTLS:1X0.045KGS LEVOSIMENDAN GRADE:IH","address":"FLAT,NO.505, 5TH FLR.,UNIQUE TOWER,","city":"MUMBAI, MAHARASHTRA","supplier":"MELODY HEALTHCARE PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"ANKARA","customer":"AS PER INVOICE","customerCountry":"TURKEY","quantity":"0.05","actualQuantity":"0.045","unit":"KGS","unitRateFc":"425000","totalValueFC":"18799.1","currency":"USD","unitRateINR":34688888.888888888,"date":"05-Mar-2024","totalValueINR":"1561000","totalValueInUsd":"18799.1","indian_port":"Bombay Air","hs_no":"29334900","bill_no":"8072347","productDescription":"API","marketType":"","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"FLAT,NO.505, 5TH FLR.,UNIQUE TOWER,, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711564200,"product":"PHARMACEUTICAL RAW MATERIAL FOR MEDICALUSE: LEVOSIMENDAN (CAS NO. 141505-33-1)","address":"NAND COTTAGE, ST. BRAZ ROAD","city":"MUMBAI, MAHARASHTRA","supplier":"SIDDHAMBIKA IMPEX","supplierCountry":"INDIA","foreign_port":"MOSCOW","customer":"UNDISCLOSED","customerCountry":"RUSSIA","quantity":"0.00","actualQuantity":"0.1","unit":"GMS","unitRateFc":"1450","totalValueFC":"139.1","currency":"USD","unitRateINR":115528.29999999999,"date":"28-Mar-2024","totalValueINR":"11552.83","totalValueInUsd":"139.1","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"8689500","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"NAND COTTAGE, ST. BRAZ ROAD, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734460200,"product":"LEVOSIMENDAN (INHOUSE PRIMARY STANDARD)[QTY: 100MG] (TAX INV NO. SPLI\/ID242504655, GSTIN NO. 27ABACS1984P1ZO, M\/S. SIM","address":"CAMUS HOUSE, 29-B,","city":"JAIPUR, RAJASTHAN.","supplier":"CAMUS PHARMA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"PSK PHARMA LTD","customerCountry":"RUSSIA","quantity":"0.00","actualQuantity":"0.1","unit":"GMS","unitRateFc":"7530.9","totalValueFC":"743.6","currency":"USD","unitRateINR":631840.29999999993,"date":"18-Dec-2024","totalValueINR":"63184.03","totalValueInUsd":"743.6","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"6546937","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"CAMUS HOUSE, 29-B,, JAIPUR, RAJASTHAN.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736101800,"product":"PHARMACEUTICAL RAW MATERIAL LEVOSIMENDANBATCH NO. 7LSD424001 EFFECTIVE DATE:19,FEB 2024VALID UP TO 18,FEB 2028","address":"T-184, MIDC, BHOSARI,","city":"PUNE-MAHARASHTRA","supplier":"EMCURE PHARMACEUTICALS LTD","supplierCountry":"INDIA","foreign_port":"HAMBURG - FUHLSBUETT","customer":"RHENUS FREIGHT LOGISTICS GMBH CO","customerCountry":"GERMANY","quantity":"0.09","actualQuantity":"0.09","unit":"KGS","unitRateFc":"600000","totalValueFC":"52970.7","currency":"USD","unitRateINR":50751333.333333336,"date":"06-Jan-2025","totalValueINR":"4567620","totalValueInUsd":"52970.7","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"7046975","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"T-184, MIDC, BHOSARI,, PUNE-MAHARASHTRA","customerAddress":""}]
28-Feb-2022
06-Jan-2025
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Drugs in Development

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Details:

Amendment to the existing agreement gives Tenax rights to develop and commercialize in the United States and Canada an oral formulation of levosimendan for use with Type 2 pulmonary hypertension in heart failure patients with PH-HFpEF, or other heart related indications.


Lead Product(s): Levosimendan,Inapplicable

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Tenax Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement October 15, 2020

Fermion Orion Company Banner

01

Details : Amendment to the existing agreement gives Tenax rights to develop and commercialize in the United States and Canada an oral formulation of levosimendan for use with Type 2 pulmonary hypertension in heart failure patients with PH-HFpEF, or other heart rel...

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

October 15, 2020

Fermion Orion Company Banner

Details:

TNX-103 (levosimendan) is an oral PDE3, small molecule drug candidate, which is currently being evaluated for the treatment of patients with PH-HFpEF.


Lead Product(s): Levosimendan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 05, 2025

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02

OTS 2025
Not Confirmed
OTS 2025
Not Confirmed

Details : TNX-103 (levosimendan) is an oral PDE3, small molecule drug candidate, which is currently being evaluated for the treatment of patients with PH-HFpEF.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

March 05, 2025

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Details:

The Company intends to use the net proceeds to advance its ongoing and planned Phase 3 clinical trials, including TNX-103 (oral levosimendan) in patients with PH-HFpEF.


Lead Product(s): Levosimendan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Leerink Partners

Deal Size: $25.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement March 05, 2025

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03

OTS 2025
Not Confirmed
OTS 2025
Not Confirmed

Details : The Company intends to use the net proceeds to advance its ongoing and planned Phase 3 clinical trials, including TNX-103 (oral levosimendan) in patients with PH-HFpEF.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

March 05, 2025

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Details:

The funding will support the advancement of oral TNX-103 (levosimendan) phase 3 development program for the treatment of Pulmonary Hypertension Due to Heart Failure with Preserved Ejection Fraction.


Lead Product(s): Levosimendan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: BVF Partners

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement August 12, 2024

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04

OTS 2025
Not Confirmed
OTS 2025
Not Confirmed

Details : The funding will support the advancement of oral TNX-103 (levosimendan) phase 3 development program for the treatment of Pulmonary Hypertension Due to Heart Failure with Preserved Ejection Fraction.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

August 12, 2024

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Details:

The Company intends to use the net proceeds from the private placement to complete its ongoing late-stage clinical trial studies with Patients for the treatment of PH-HFpEF.


Lead Product(s): Levosimendan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: BVF Partners

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement August 06, 2024

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05

OTS 2025
Not Confirmed
OTS 2025
Not Confirmed

Details : The Company intends to use the net proceeds from the private placement to complete its ongoing late-stage clinical trial studies with Patients for the treatment of PH-HFpEF.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

August 06, 2024

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Details:

Under the license agreement, Tenax will be developing and commercializing the TNX-103 (levosimendan) for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction.


Lead Product(s): Levosimendan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Orion Corporation

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement February 20, 2024

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06

OTS 2025
Not Confirmed
OTS 2025
Not Confirmed

Details : Under the license agreement, Tenax will be developing and commercializing the TNX-103 (levosimendan) for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

February 20, 2024

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Details:

The company intends to use the net proceeds for the clinical development of TNX-103 (levosimendan) for the treatment of pulmonary hypertension and heart failure with preserved ejection fraction.


Lead Product(s): Levosimendan,Inapplicable

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Roth Capital Partners

Deal Size: $9.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering February 08, 2024

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07

OTS 2025
Not Confirmed
OTS 2025
Not Confirmed

Details : The company intends to use the net proceeds for the clinical development of TNX-103 (levosimendan) for the treatment of pulmonary hypertension and heart failure with preserved ejection fraction.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

February 08, 2024

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Details:

TNX-103 (levosimendan) is in Phase 3 trials for pulmonary hypertension in heart failure with preserved ejection fraction, acting as a potassium ATP channel activator.


Lead Product(s): Levosimendan,Inapplicable

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 07, 2024

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08

OTS 2025
Not Confirmed
OTS 2025
Not Confirmed

Details : TNX-103 (levosimendan) is in Phase 3 trials for pulmonary hypertension in heart failure with preserved ejection fraction, acting as a potassium ATP channel activator.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 07, 2024

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Details:

TNX-103 (levosimendan), is an oral, small molecule, unique potassium ATP channel activator and calcium sensitizer, being developed for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction. There are currently no FDA approved treatments for PH-HFpEF.


Lead Product(s): Levosimendan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 13, 2023

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09

OTS 2025
Not Confirmed
OTS 2025
Not Confirmed

Details : TNX-103 (levosimendan), is an oral, small molecule, unique potassium ATP channel activator and calcium sensitizer, being developed for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction. There are currently no FDA approved treatme...

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

November 13, 2023

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Details:

TNX-103 (levosimendan), is an oral, small molecule, unique potassium ATP channel activator and calcium sensitizer, being developed for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction. There are currently no FDA approved treatments for PH-HFpEF.


Lead Product(s): Levosimendan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 31, 2023

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10

OTS 2025
Not Confirmed
OTS 2025
Not Confirmed

Details : TNX-103 (levosimendan), is an oral, small molecule, unique potassium ATP channel activator and calcium sensitizer, being developed for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction. There are currently no FDA approved treatme...

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 31, 2023

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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

CAS Number : 36725-28-7

End Use API : Levosimendan

About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...

Shandong Loncom Pharmaceutical company banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

CAS Number : 36725-28-7

End Use API : Levosimendan

About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...

Shandong Loncom Pharmaceutical company banner

03

LinkChem

China
OTS 2025
Not Confirmed
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LinkChem

China
OTS 2025
Not Confirmed
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CAS Number : 36725-28-7

End Use API : Levosimendan

About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

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FDF Dossiers

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01

LEVOSIMENDAN

Brand Name : Simdax

Dosage Form : Concentrate to the infusion fluid, resolution

Dosage Strength : 2.5 mg/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

02

LEVOSIMENDAN

Brand Name : Simdax

Dosage Form : Concentrate to the infusion fluid, resolution

Dosage Strength : 2.5 mg/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

03

Levosimendan

Brand Name : Simdax

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 2.5mg/ml

Packaging :

Approval Date : 22/09/2000

Application Number : 20000922000137

Regulatory Info : Approved

Registration Country : Sweden

Fermion Orion Company Banner

04

Levosimendan

Brand Name : Simdax

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 2.5MG

Packaging :

Approval Date : 2001-08-03

Application Number : 64154

Regulatory Info : Authorized

Registration Country : Spain

Fermion Orion Company Banner

05

Ethypharm

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : France

Levosimendan

Brand Name :

Dosage Form : Vial

Dosage Strength : 2.5MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

06

Ever Pharma

Austria
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEver Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

Flag Austria
Digital Content Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Levosimendan

Brand Name : Levosimendan Ever Pharma

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 2.5MG

Packaging :

Approval Date : 2023-05-22

Application Number : 88852

Regulatory Info : Authorized

Registration Country : Spain

Ever Pharma CB

07

Altan Pharma

Spain
OTS 2025
Not Confirmed
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Altan Pharma

Spain
arrow
OTS 2025
Not Confirmed

Levosimendan

Brand Name : Levosimendan Altan

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 2.5mg/ml

Packaging :

Approval Date : 01/06/2021

Application Number : 20200317000050

Regulatory Info : Approved

Registration Country : Sweden

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08

OTS 2025
Not Confirmed
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arrow
OTS 2025
Not Confirmed

Levosimendan

Brand Name : Levosimendan Amdipharm

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 2.5mg/ml

Packaging :

Approval Date : 26/01/2022

Application Number : 20200812000036

Regulatory Info : Approved

Registration Country : Sweden

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09

OTS 2025
Not Confirmed
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OTS 2025
Not Confirmed

LEVOSIMENDAN

Brand Name :

Dosage Form : IV Infusion

Dosage Strength : 2.5MG/1ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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10

Polifarma

Turkey
OTS 2025
Not Confirmed
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Polifarma

Turkey
arrow
OTS 2025
Not Confirmed

Levosimendan

Brand Name :

Dosage Form : Concentrated Solution for IV Infusion

Dosage Strength : 12.5MG/5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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Digital Content read-more

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NEWS #PharmaBuzz

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https://www.globenewswire.com/news-release/2025/09/16/3150630/12401/en/Tenax-Therapeutics-Announces-European-Patent-Office-Intention-to-Grant-Patent-Covering-Use-of-Levosimendan-in-PH-HFpEF.html

GLOBENEWSWIRE
16 Sep 2025

https://www.globenewswire.com/news-release/2025/03/05/3037413/12401/en/Tenax-Therapeutics-Expands-Phase-3-LEVEL-Program-Advancing-Two-TNX-103-Oral-Levosimendan-Registrational-Studies-for-the-Treatment-of-PH-HFpEF.html

GLOBENEWSWIRE
05 Mar 2025

https://www.globenewswire.com/news-release/2024/08/13/2929628/0/en/Tenax-Therapeutics-Reports-Second-Quarter-2024-Financial-Results-and-Provides-a-Corporate-Update.html

GLOBENEWSWIRE
13 Aug 2024

https://www.globenewswire.com/news-release/2024/04/30/2872119/0/en/Tenax-Therapeutics-Announces-New-U-S-Patent-Covering-the-Use-of-Levosimendan-in-Pulmonary-Hypertension-with-Heart-Failure-with-Preserved-Ejection-Fraction-PH-HFpEF.html

GLOBENEWSWIRE
30 Apr 2024
Tenax Therapeutics Hosts KOL Event
Tenax Therapeutics Hosts KOL Event

09 Apr 2024

// GLOBENEWSWIRE

https://www.globenewswire.com/news-release/2024/04/09/2859987/0/en/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.html

GLOBENEWSWIRE
09 Apr 2024

https://www.globenewswire.com/news-release/2024/03/28/2854007/0/en/Tenax-Therapeutics-Provides-Business-and-Clinical-Development-Updates-with-Full-Year-2023-Financial-Results.html

GLOBENEWSWIRE
28 Mar 2024

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APIs

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FDF DOSSIERS

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ABOUT THIS PAGE

Looking for 141505-33-1 / Levosimendan API manufacturers, exporters & distributors?

Levosimendan manufacturers, exporters & distributors 1

42

PharmaCompass offers a list of Levosimendan API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Levosimendan manufacturer or Levosimendan supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levosimendan manufacturer or Levosimendan supplier.

PharmaCompass also assists you with knowing the Levosimendan API Price utilized in the formulation of products. Levosimendan API Price is not always fixed or binding as the Levosimendan Price is obtained through a variety of data sources. The Levosimendan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Levosimendan

Synonyms

141505-33-1, Simdax, (r)-simendan, (-)-or-1259, Or-1259, Simendan, (r)-

Cas Number

141505-33-1

Unique Ingredient Identifier (UNII)

C6T4514L4E

About Levosimendan

A hydrazone and pyridazine derivative; the levo-form is a phosphodiesterase III inhibitor, calcium-sensitizing agent, and inotropic agent that is used in the treatment of HEART FAILURE.

Levosimendan Manufacturers

A Levosimendan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levosimendan, including repackagers and relabelers. The FDA regulates Levosimendan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levosimendan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Levosimendan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Levosimendan Suppliers

A Levosimendan supplier is an individual or a company that provides Levosimendan active pharmaceutical ingredient (API) or Levosimendan finished formulations upon request. The Levosimendan suppliers may include Levosimendan API manufacturers, exporters, distributors and traders.

click here to find a list of Levosimendan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Levosimendan USDMF

A Levosimendan DMF (Drug Master File) is a document detailing the whole manufacturing process of Levosimendan active pharmaceutical ingredient (API) in detail. Different forms of Levosimendan DMFs exist exist since differing nations have different regulations, such as Levosimendan USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Levosimendan DMF submitted to regulatory agencies in the US is known as a USDMF. Levosimendan USDMF includes data on Levosimendan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levosimendan USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Levosimendan suppliers with USDMF on PharmaCompass.

Levosimendan WC

A Levosimendan written confirmation (Levosimendan WC) is an official document issued by a regulatory agency to a Levosimendan manufacturer, verifying that the manufacturing facility of a Levosimendan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levosimendan APIs or Levosimendan finished pharmaceutical products to another nation, regulatory agencies frequently require a Levosimendan WC (written confirmation) as part of the regulatory process.

click here to find a list of Levosimendan suppliers with Written Confirmation (WC) on PharmaCompass.

Levosimendan GMP

Levosimendan Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Levosimendan GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Levosimendan GMP manufacturer or Levosimendan GMP API supplier for your needs.

Levosimendan CoA

A Levosimendan CoA (Certificate of Analysis) is a formal document that attests to Levosimendan's compliance with Levosimendan specifications and serves as a tool for batch-level quality control.

Levosimendan CoA mostly includes findings from lab analyses of a specific batch. For each Levosimendan CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Levosimendan may be tested according to a variety of international standards, such as European Pharmacopoeia (Levosimendan EP), Levosimendan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levosimendan USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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