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Chemistry

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Also known as: Ketoconazole, Levoketoconazole, Panfungol, Ketoderm, Fungarest, Fungoral
Molecular Formula
C26H28Cl2N4O4
Molecular Weight
531.4  g/mol
InChI Key
XMAYWYJOQHXEEK-ZEQKJWHPSA-N
FDA UNII
R9400W927I

Levoketoconazole
Broad spectrum antifungal agent used for long periods at high doses, especially in immunosuppressed patients.
Levoketoconazole is a Cortisol Synthesis Inhibitor. The mechanism of action of levoketoconazole is as a Cytochrome P450 11B1 Inhibitor, and Cytochrome P450 11A1 Inhibitor, and Cytochrome P450 17A1 Inhibitor, and Cytochrome P450 3A4 Inhibitor, and P-Glycoprotein Inhibitor, and Organic Cation Transporter 2 Inhibitor, and Multidrug and Toxin Extrusion Transporter 1 Inhibitor, and Cytochrome P450 2B6 Inhibitor, and Cytochrome P450 2C8 Inhibitor.
1 2D Structure

Levoketoconazole

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-[4-[4-[[(2S,4R)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanone
2.1.2 InChI
InChI=1S/C26H28Cl2N4O4/c1-19(33)31-10-12-32(13-11-31)21-3-5-22(6-4-21)34-15-23-16-35-26(36-23,17-30-9-8-29-18-30)24-7-2-20(27)14-25(24)28/h2-9,14,18,23H,10-13,15-17H2,1H3/t23-,26-/m1/s1
2.1.3 InChI Key
XMAYWYJOQHXEEK-ZEQKJWHPSA-N
2.1.4 Canonical SMILES
CC(=O)N1CCN(CC1)C2=CC=C(C=C2)OCC3COC(O3)(CN4C=CN=C4)C5=C(C=C(C=C5)Cl)Cl
2.1.5 Isomeric SMILES
CC(=O)N1CCN(CC1)C2=CC=C(C=C2)OC[C@@H]3CO[C@@](O3)(CN4C=CN=C4)C5=C(C=C(C=C5)Cl)Cl
2.2 Other Identifiers
2.2.1 UNII
R9400W927I
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Ketoconazole

2. R 41400

3. R-41400

4. R41,400

5. R41400

2.3.2 Depositor-Supplied Synonyms

1. Ketoconazole

2. Levoketoconazole

3. Panfungol

4. Ketoderm

5. Fungarest

6. Fungoral

7. Ketoisdin

8. Normocort

9. Extina

10. Orifungal M

11. (-)-ketoconazole

12. 65277-42-1

13. Ketoconazol

14. Ketozole

15. 142128-57-2

16. 2s,4r Ketoconazole

17. 2s,4r-ketoconazole

18. Cor-003

19. Ketoconazole, (2s,4r)-

20. (2s,4r)-ketoconazole

21. Cor003

22. Xolegel

23. (-)-(2s,4r)-ketoconazole

24. Levoketoconazole [usan]

25. Dio-902

26. 2dj8r0nt7k

27. Ketocanazole

28. Ketoconazolum

29. Kuric

30. Chembl295698

31. Chebi:47518

32. R9400w927i

33. 1-[4-[4-[[(2s,4r)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanone

34. R-41400

35. Nizoral A-d

36. 1-(4-(4-(((2s,4r)-2-((1h-imidazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)ethan-1-one

37. 1-acetyl-4-(4-{[(2s,4r)-2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine

38. Cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine

39. Ethanone, 1-(4-(4-(((2s,4r)-2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-1-piperazinyl)-

40. Piperazine, 1-acetyl-4-(4-((2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-, Cis-

41. Brizoral

42. Sebazole

43. Teryzolin

44. Terzolin

45. Onofin K

46. Nsc 317629

47. Ketoconazol [inn-spanish]

48. Ketoconazolum [inn-latin]

49. (+-)-cis-1-acetyl-4-(p-((2-(2,4-dichlorophenyl)-2-(imidazol-1- Ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazine

50. 1-[4-(4-{[(2r,4s)-2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]ethan-1-one

51. Piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, Cis-

52. R 41,400

53. Unii-2dj8r0nt7k

54. J02ab02

55. Recorlev

56. (+)-(2r,4s)-ketoconazole

57. Feoris, Nizoral

58. Unii-r9400w927i

59. Hsdb 7447

60. (-)-ketoconazol

61. Ncgc00016907-01

62. R 41400

63. Einecs 265-667-4

64. Nizoral (tn)

65. Xolegel (tn)

66. Cas-65277-42-1

67. Kw-1414

68. Brn 4303081

69. Ketoconazole [usan:usp:inn:ban:jan]

70. Ketoconazole [mi]

71. Lopac-k-1003

72. Ketoconazole [inn]

73. Ketoconazole [jan]

74. Ketoconazole [hsdb]

75. Ketoconazole [inci]

76. Ketoconazole [usan]

77. Ketoconazole (jp17/usp)

78. Ketoconazole [vandf]

79. Schembl41473

80. Ketoconazole [mart.]

81. Levoketoconazole (usan/inn)

82. Mls006010227

83. Ketoconazole [usp-rs]

84. Ketoconazole [who-dd]

85. Levoketoconazole [inn]

86. Cort-001

87. Bdbm31768

88. Gtpl11829

89. Hy-b0105b

90. Dtxsid60161949

91. Levoketoconazole [who-dd]

92. Ketoconazole [ep Impurity]

93. Ketoconazole [orange Book]

94. Zinc643153

95. Ketoconazole [ep Monograph]

96. Ketoconazole [usp Impurity]

97. Act02655

98. Ketoconazole [usp Monograph]

99. Ketoconazolum [who-ip Latin]

100. Akos022172422

101. Db05667

102. Ds-6676

103. Ncgc00015577-01

104. Ncgc00016907-02

105. Ncgc00016907-03

106. Ncgc00016907-04

107. Ncgc00161836-01

108. Ncgc00161836-02

109. (+-)-cis-1-acetyl-4-(p-((2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazine

110. Smr001819845

111. Cs-0016830

112. D00351

113. D10950

114. Q27120779

115. (-)-r 41400

116. (+/-)-cis-1-acetyl-4-(p-((2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazine

117. (2s,4r)-1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine

118. 1-[4-(4-{[(2s,4r)-2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]ethan-1-one

119. 72093-26-6

120. Cis-1-acetyl-4-(4-((2-(2,4-dichlorophenyl)-2-(1h- Imidazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-ketoconazol

121. Ethanone, 1-[4-[4-[[(2r,4s)-2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]-, Rel-

122. Piperazine, (-)-1-acetyl-4-[4-[[(2s,4r)-2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-

123. Piperazine, 1-acetyl-4-(4-((2-(2,4-dichlorophenyl)-2-(1h- Imidazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-, Cis-

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 531.4 g/mol
Molecular Formula C26H28Cl2N4O4
XLogP34.3
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count6
Rotatable Bond Count7
Exact Mass530.1487608 g/mol
Monoisotopic Mass530.1487608 g/mol
Topological Polar Surface Area69.1 Ų
Heavy Atom Count36
Formal Charge0
Complexity735
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Therapeutic Uses

Antifungal agents

National Library of Medicine's Medical Subject Headings. Ketoconazole. Online file (MeSH, 2014). Available from, as of August 28, 2014: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html


Nizoral Tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Nizoral (ketoconazole) Tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Nizoral Tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid. /Included in US product label/

NIH; DailyMed. Current Medication Information for Nizoral (Ketoconazole) Tablet (Revised: March 2014). Available from, as of November 11, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=090660c1-6e6d-457f-adb5-046ddfcd1465


Oral ketoconazole has been used for the palliative treatment of Cushing's syndrome (hypercortisolism), including adrenocortical hyperfunction associated with adrenal or pituitary adenoma or ectopic corticotropin-secreting tumors. Based on ketoconazole's endocrine effects, the drug has been used in the treatment of advanced prostatic carcinoma. Safety and efficacy of ketoconazole have not been established for either of these indications. Oral ketoconazole also has been used in the treatment of hypercalcemia in patients with sarcoidosis and the treatment of tuberculosis-associated hypercalcemia and idiopathic infantile hypercalcemia and hypercalciuria. /NOT included in US product label/

American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014


Ketoconazole has been used for the treatment of sporotrichosis caused by Sporothrix schenckii; however, the drug is not recommended since it is less effective and associated with more adverse effects than some other azoles. Oral itraconazole is considered the drug of choice for the treatment of cutaneous, lymphocutaneous, or mild pulmonary or osteoarticular sporotrichosis and for follow-up therapy in more severe infections after a response has been obtained with IV amphotericin B. /NOT included in US product label/

American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014


For more Therapeutic Uses (Complete) data for KETOCONAZOLE (18 total), please visit the HSDB record page.


4.2 Drug Warning

/BOXED WARNING/ WARNING. Nizoral Tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Hepatotoxicity: Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation has occurred with the use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored. QT Prolongation and Drug Interactions Leading to QT Prolongation: Co-administration of the following drugs with ketoconazole is contraindicated: dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, ranolazine. Ketoconazole can cause elevated plasma concentrations of these drugs and may prolong QT intervals, sometimes resulting in life-threatening ventricular dysrhythmias such as torsades de pointes.

NIH; DailyMed. Current Medication Information for Nizoral (Ketoconazole) Tablet (Revised: March 2014). Available from, as of November 11, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=090660c1-6e6d-457f-adb5-046ddfcd1465


Transient increases in serum AST, ALT, and alkaline phosphatase concentrations may occur during ketoconazole therapy. Serious hepatotoxicity has occurred in patients receiving oral ketoconazole, including cases that were fatal or required liver transplantation. Hepatotoxicity may be hepatocellular (in most cases), cholestatic, or a mixed pattern of injury. Although ketoconazole-induced hepatotoxicity usually is reversible following discontinuance of the drug, recovery may take several months and rarely death has occurred. Symptomatic hepatotoxicity usually is apparent within the first few months of ketoconazole therapy, but occasionally may be apparent within the first week of therapy. Some patients with ketoconazole-induced hepatotoxicity had no obvious risk factors for liver disease. Serious hepatotoxicity has been reported in patients receiving high oral ketoconazole dosage for short treatment durations and in patients receiving low oral dosage of the drug for long durations. Many of the reported cases of hepatotoxicity occurred in patients who received the drug for the treatment of tinea unguium (onychomycosi or the treatment of chronic, refractory dermatophytoses. Ketoconazole-induced hepatitis has been reported in some children.

American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 521


Coadministration of a number of CYP3A4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with Nizoral Tablets. Coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious adverse reaction may occur. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and sometimes resulting in life-threatening ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia. Additionally, the following other drugs are contraindicated with Nizoral Tablets: methadone, disopyramide, dronedarone, ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine, methylergometrine, irinotecan, lurasidone, oral midazolam, alprazolam, triazolam, felodipine, nisoldipine, ranolazine, tolvaptan, eplerenone, lovastatin, simvastatin and colchicine.

NIH; DailyMed. Current Medication Information for Nizoral (Ketoconazole) Tablet (Revised: March 2014). Available from, as of November 11, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=090660c1-6e6d-457f-adb5-046ddfcd1465


The use of Nizoral Tablets is contraindicated in patients with acute or chronic liver disease.

NIH; DailyMed. Current Medication Information for Nizoral (Ketoconazole) Tablet (Revised: March 2014). Available from, as of November 11, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=090660c1-6e6d-457f-adb5-046ddfcd1465


For more Drug Warnings (Complete) data for KETOCONAZOLE (46 total), please visit the HSDB record page.


4.3 Drug Indication

Investigated for use/treatment in diabetes mellitus type 2.


Ketoconazole HRA is indicated for the treatment of endogenous Cushings syndrome in adults and adolescents above the age of 12 years.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

14-alpha Demethylase Inhibitors

Compounds that specifically inhibit STEROL 14-DEMETHYLASE. A variety of azole-derived ANTIFUNGAL AGENTS act through this mechanism. (See all compounds classified as 14-alpha Demethylase Inhibitors.)


Antifungal Agents

Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)


Cytochrome P-450 CYP3A Inhibitors

Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP3A. (See all compounds classified as Cytochrome P-450 CYP3A Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
LEVOKETOCONAZOLE
5.2.2 FDA UNII
2DJ8R0NT7K
5.2.3 Pharmacological Classes
Cytochrome P450 11A1 Inhibitors [MoA]; Cytochrome P450 11B1 Inhibitors [MoA]; Cytochrome P450 17A1 Inhibitors [MoA]; Cytochrome P450 2B6 Inhibitors [MoA]; Cytochrome P450 2C8 Inhibitors [MoA]; Cytochrome P450 3A4 Inhibitors [MoA]; Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]; Organic Cation Transporter 2 Inhibitors [MoA]; P-Glycoprotein Inhibitors [MoA]; Cortisol Synthesis Inhibitor [EPC]
5.3 ATC Code

J02AB02


D - Dermatologicals

D01 - Antifungals for dermatological use

D01A - Antifungals for topical use

D01AC - Imidazole and triazole derivatives

D01AC08 - Ketoconazole


G - Genito urinary system and sex hormones

G01 - Gynecological antiinfectives and antiseptics

G01A - Antiinfectives and antiseptics, excl. combinations with corticosteroids

G01AF - Imidazole derivatives

G01AF11 - Ketoconazole


H - Systemic hormonal preparations, excl. sex hormones and insulins

H02 - Corticosteroids for systemic use

H02C - Antiadrenal preparations

H02CA - Anticorticosteroids

H02CA03 - Ketoconazole


J - Antiinfectives for systemic use

J02 - Antimycotics for systemic use

J02A - Antimycotics for systemic use

J02AB - Imidazole derivatives

J02AB02 - Ketoconazole


5.4 Absorption, Distribution and Excretion

Ketoconazole is rapidly absorbed from the GI tract. Following oral administration, ketoconazole is dissolved in gastric secretions and converted to the hydrochloride salt prior to absorption from the stomach.

American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014


The effect of food on the rate and extent of GI absorption of ketoconazole has not been clearly determined. Some clinicians have reported that administration of ketoconazole to fasting individuals results in higher plasma concentrations of the drug than does administration with food. However, the manufacturer states that administration of ketoconazole with food increases the extent of absorption and results in more consistent plasma concentrations of the drug. The manufacturer suggests that food increases absorption of ketoconazole by increasing the rate and/or extent of dissolution of ketoconazole (e.g., by increasing bile secretions) or by delaying stomach emptying.

American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014


Ketoconazole is a weak dibasic agent and thus requires acidity for dissolution and absorption.

NIH; DailyMed. Current Medication Information for Nizoral (Ketoconazole) Tablet (Revised: March 2014). Available from, as of November 11, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=090660c1-6e6d-457f-adb5-046ddfcd1465


The bioavailability of oral ketoconazole depends on the pH of the gastric contents in the stomach; an increase in the pH results in decreased absorption of the drug. Decreased bioavailability of ketoconazole has been reported in patients with acquired immunodeficiency syndrome (AIDS), probably because of gastric hypochlorhydria associated with this condition; concomitant administration of dilute hydrochloric acid solution normalized absorption of the drug in these patients.198 Concomitant administration of an acidic beverage may increase bioavailability of oral ketoconazole in some individuals with achlorhydria.

American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014


For more Absorption, Distribution and Excretion (Complete) data for KETOCONAZOLE (19 total), please visit the HSDB record page.


5.5 Metabolism/Metabolites

Ketoconazole is partially metabolized, in the liver, to several inactive metabolites by oxidation and degradation of the imidazole and piperazine rings, by oxidative O-dealkylation, and by aromatic hydroxylation.

American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014


5.6 Biological Half-Life

Plasma concentrations of ketoconazole appear to decline in a biphasic manner with a half-life of approximately 2 hours in the initial phase and approximately 8 hours in the terminal phase.

American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014


Elimination from plasma is biphasic with a half-life of 2 hours during the first 10 hours and 8 hours thereafter.

NIH; DailyMed. Current Medication Information for Nizoral (Ketoconazole) Tablet (Revised: March 2014). Available from, as of November 11, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=090660c1-6e6d-457f-adb5-046ddfcd1465


5.7 Mechanism of Action

Preliminary data suggests that DIO-902 increases insulin sensitivity by lowering cortisol levels. The primary mechanism of action is via inhibition of the 11--hydroxylase enzyme, the terminal step in cortisol synthesis in the adrenal gland. DIO-902 has also been shown to lower total and LDL-cholesterol by inhibiting 14--demethylase, a key enzyme in cholesterol synthesis. In combination with a typical glucose-lowering agent, such as metformin, DIO-902 may enhance glucose control and improve total and LDL-cholesterol. [DiObex Press Release]


Ketoconazole blocks the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450 dependent enzyme lanosterol 14alpha-demethylase responsible for the conversion of lanosterol to ergosterol in the fungal cell membrane. This results in an accumulation of methylated sterol precursors and a depletion of ergosterol within the cell membrane thus weakening the structure and function of the fungal cell membrane.

NIH; DailyMed. Current Medication Information for Nizoral (Ketoconazole) Tablet (Revised: March 2014). Available from, as of November 11, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=090660c1-6e6d-457f-adb5-046ddfcd1465


Like other azole antifungal agents, ketoconazole presumably exerts its antifungal activity by altering cellular membranes, resulting in increased membrane permeability, secondary metabolic effects, and growth inhibition. Although the exact mechanism of action of ketoconazole has not been fully determined, it has been suggested that the fungistatic activity of the drug may result from interference with ergosterol synthesis, probably via inhibition of C-14 demethylation of sterol intermediates (e.g., lanosterol). The fungicidal activity of ketoconazole at high concentrations may result from a direct physiochemical effect of the drug on the fungal cell membrane.

American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014


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Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

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Levoketoconazole

About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...

Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs), including Highly Potent. In 2016, Medichem merged with Combino Pharm, which is devoted to the development and manufacture (licensing) of Finished Dosage Forms. With this merger, Medichem has become a vertically integrated pharmaceutical company which can offer a complete range of products and services for the pharmaceutical industry with the highest standards of quality, operational excellence and environment respect.
Medichem
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Drugs in Development

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Details:

Recorlev® (levoketoconazole) is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.


Lead Product(s): Levoketoconazole

Therapeutic Area: Endocrinology Brand Name: Recorlev

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 30, 2023

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01

Pharmatech Expo 2025
Not Confirmed
Pharmatech Expo 2025
Not Confirmed

Details : Recorlev® (levoketoconazole) is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.

Brand Name : Recorlev

Molecule Type : Small molecule

Upfront Cash : Not Applicable

January 30, 2023

blank

Details:

Recorlev® (levoketoconazole) is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.


Lead Product(s): Levoketoconazole

Therapeutic Area: Endocrinology Brand Name: Recorlev

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 01, 2022

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02

Pharmatech Expo 2025
Not Confirmed
Pharmatech Expo 2025
Not Confirmed

Details : Recorlev® (levoketoconazole) is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.

Brand Name : Recorlev

Molecule Type : Small molecule

Upfront Cash : Not Applicable

November 01, 2022

blank

Details:

Recorlev® (levoketoconazole) is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.


Lead Product(s): Levoketoconazole

Therapeutic Area: Endocrinology Brand Name: Recorlev

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 12, 2022

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03

Pharmatech Expo 2025
Not Confirmed
Pharmatech Expo 2025
Not Confirmed

Details : Recorlev® (levoketoconazole) is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.

Brand Name : Recorlev

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 12, 2022

blank

Details:

Levoketoconazole (Recorlev) is an important and welcome new therapeutic option for clinicians to help manage patients with endogenous Cushing's syndrome, a severe, potentially life-threatening rare disease.


Lead Product(s): Levoketoconazole

Therapeutic Area: Endocrinology Brand Name: Recorlev

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 30, 2021

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04

Pharmatech Expo 2025
Not Confirmed
Pharmatech Expo 2025
Not Confirmed

Details : Levoketoconazole (Recorlev) is an important and welcome new therapeutic option for clinicians to help manage patients with endogenous Cushing's syndrome, a severe, potentially life-threatening rare disease.

Brand Name : Recorlev

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 30, 2021

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Details:

The Company intends to use the net proceeds to continue development and regulatory activities, facilitate commercial readiness and commercially launch Recorlev primarily in the US, support the life cycle management activities of Keveyis and for general corporate purposes.


Lead Product(s): Levoketoconazole

Therapeutic Area: Endocrinology Brand Name: Recorlev

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Jefferies

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Public Offering September 16, 2020

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05

Pharmatech Expo 2025
Not Confirmed
Pharmatech Expo 2025
Not Confirmed

Details : The Company intends to use the net proceeds to continue development and regulatory activities, facilitate commercial readiness and commercially launch Recorlev primarily in the US, support the life cycle management activities of Keveyis and for general c...

Brand Name : Recorlev

Molecule Type : Small molecule

Upfront Cash : Undisclosed

September 16, 2020

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Details:

The Phase 3 program for RECORLEV consists of SONICS and LOGICS: two multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushing’s syndrome. The SONICS study met its primary and secondary endpoints.


Lead Product(s): Levoketoconazole

Therapeutic Area: Endocrinology Brand Name: Recorlev

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 01, 2020

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06

Pharmatech Expo 2025
Not Confirmed
Pharmatech Expo 2025
Not Confirmed

Details : The Phase 3 program for RECORLEV consists of SONICS and LOGICS: two multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushing’s syndrome. The SONICS study met its primary and secondary endpoint...

Brand Name : Recorlev

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 01, 2020

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Details:

The fund obtained from the debt facility will help Strongbridge Biopharma to accelerate clinical development program for RECORLEV® (levoketoconazole) and the commercial progress and potential of KEVEYIS® (dichlorphenamide).


Lead Product(s): Levoketoconazole

Therapeutic Area: Endocrinology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Avenue Venture Opportunities Fund

Deal Size: $30.0 million Upfront Cash: Undisclosed

Deal Type: Financing May 20, 2020

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07

Pharmatech Expo 2025
Not Confirmed
Pharmatech Expo 2025
Not Confirmed

Details : The fund obtained from the debt facility will help Strongbridge Biopharma to accelerate clinical development program for RECORLEV® (levoketoconazole) and the commercial progress and potential of KEVEYIS® (dichlorphenamide).

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Undisclosed

May 20, 2020

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Details:

Strongbridge has completed enrollment in the Phase 3 LOGICS study for RECORLEV® (levoketoconazole), for the treatment of endogenous Cushing’s syndrome.


Lead Product(s): Levoketoconazole

Therapeutic Area: Endocrinology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 11, 2020

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08

Pharmatech Expo 2025
Not Confirmed
Pharmatech Expo 2025
Not Confirmed

Details : Strongbridge has completed enrollment in the Phase 3 LOGICS study for RECORLEV® (levoketoconazole), for the treatment of endogenous Cushing’s syndrome.

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 11, 2020

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ABOUT THIS PAGE

Levoketoconazole Manufacturers

A Levoketoconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levoketoconazole, including repackagers and relabelers. The FDA regulates Levoketoconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levoketoconazole 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 Levoketoconazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Levoketoconazole Suppliers

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

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

Levoketoconazole USDMF

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

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

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

Levoketoconazole NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Levoketoconazole as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Levoketoconazole API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Levoketoconazole as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Levoketoconazole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Levoketoconazole NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Levoketoconazole suppliers with NDC on PharmaCompass.

Levoketoconazole GMP

Levoketoconazole 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 Levoketoconazole 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 Levoketoconazole GMP manufacturer or Levoketoconazole GMP API supplier for your needs.

Levoketoconazole CoA

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

Levoketoconazole CoA mostly includes findings from lab analyses of a specific batch. For each Levoketoconazole 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.

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