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1. D 18506
2. D-18506
3. D18506
4. Hdpc
5. Hexadecylphosphocholine
6. Impavido
7. Miltex
8. N-hexadecylphosphorylcholine
1. 58066-85-6
2. Hexadecylphosphocholine
3. Impavido
4. Miltex
5. Hdpc
6. Hexadecylphosphorylcholine
7. N-hexadecylphosphorylcholine
8. Miltefosinum
9. Miltefosina
10. 1-hexadecylphosphorylcholine
11. Hexadecyl 2-(trimethylammonio)ethyl Phosphate
12. Hexadecyl Phosphocholine
13. Miltefosin C
14. N-hexadecylphosphocholine
15. D-18506
16. Hexadecyl 2-(trimethylazaniumyl)ethyl Phosphate
17. Miltefosin
18. Nsc605583
19. Hexadecyl (2-(trimethylammonio)ethyl) Phosphate
20. Miltefosine (inn)
21. Monohexadecylphosphocholine
22. Chembl125
23. Nsc-605583
24. Nsc-758968
25. Monohexadecylphosphorylcholine
26. Hepc;hexadecyl Phosphocholine
27. 53ey29w7ec
28. Chebi:75283
29. Mmv688990
30. Ncgc00095169-01
31. Miltefos
32. Miltefosine [inn]
33. Dsstox_cid_25942
34. Dsstox_rid_81240
35. Dsstox_gsid_45942
36. Miltefosinum [inn-latin]
37. Miltefosina [inn-spanish]
38. C21h46no4p
39. Miltefosine [inn:ban]
40. Fos-choline 16
41. Cas-58066-85-6
42. D 18506
43. Brn 3690495
44. Unii-53ey29w7ec
45. Miltextrade Mark
46. Hepc Hydrate
47. Impavidotrade Mark
48. D18506
49. Impavido (tn)
50. Choline, Inner Salt
51. Mfcd00133396
52. Tf-002
53. 2-(((hexadecyloxy)hydroxyphosphinyl)oxy)-n,n,n-trimethylethanaminium Hydroxide, Inner Salt
54. Nsc 605583
55. Choline Hydroxide, Hexadecyl Hydrogen Phosphate, Inner Salt
56. Choline Phosphate, Hexadecyl Ester, Hydroxide, Inner Salt
57. Miltefosine [mi]
58. Hexadecyl Phosphorylcholine
59. H-1850
60. M-7200
61. Ethanaminium, 2-(((hexadecyloxy)hydroxyphosphinyl)oxy)-n,n,n-trimethyl-, Hydroxide, Inner Salt
62. Miltefosine [mart.]
63. Schembl26215
64. Miltefosine [who-dd]
65. 4-04-00-01460 (beilstein Handbook Reference)
66. Spectrum1505329
67. Dtxsid7045942
68. Gtpl11355
69. Miltefosine [orange Book]
70. Hexadecyl Phosphorylcholine Hydrate
71. Hms1922d16
72. Hms2089j15
73. Hms3649i09
74. Pharmakon1600-01505329
75. Hexadecylphosphocholine, Miltefosine
76. Bcp04506
77. Miltefosine (hexadecylphosphocholine)
78. Tox21_111466
79. Bdbm50034220
80. Ccg-35584
81. Ccg-36097
82. Ccg-40025
83. Dl-131
84. Hexadecyl 2-(trimethyl-.lambda.~5~-azanyl)ethyl Hydrogen Phosphate
85. Nsc758968
86. S3056
87. 1-n-hexadecylphosphorylcholine
88. Akos015914886
89. Tox21_111466_1
90. Bcp9000927
91. Db09031
92. Ncgc00095169-02
93. Ncgc00095169-03
94. Ncgc00095169-05
95. Ncgc00095169-07
96. Hy-13685
97. Bcp0726000071
98. Ft-0608148
99. M2445
100. Hexadecyloxy-2-trimethylammonioethylphosphorate
101. D02494
102. Ab00642217-03
103. Ab00642217_04
104. Miltefosine, >=98% (perchloric Acid Titration)
105. A831718
106. Q411787
107. Hexadecyl 2-(trimethylammonio)ethyl Phosphate Hydrate
108. 2-[hexadecoxy(hydroxy)phosphoryl]oxyethyl-trimethyl-ammonium
109. Phosphoric Acid Hexadecyl 2-(trimethylammonio)ethyl Ester
110. [2-(hexadecyloxy-hydroxy-phosphoryloxy)-ethyl]-trimethyl-ammonium
111. 3, 4-hydroxy-n,n,n-trimethyl-, Hydroxide, Inner Salt, 4-oxide
112. Hexadecyl 2-(trimethyl-lambda~5~-azanyl)ethyl Hydrogen Phosphate
113. Phosphoric Acid Hexadecyl 2-(trimethylammonio)ethyl Ester Hydrate
114. 2-(((hexadecyloxy)hydroxyphosphinyl)oxy)-n,n,n-trimethylethanaminium Hydroxide
Molecular Weight | 407.6 g/mol |
---|---|
Molecular Formula | C21H46NO4P |
XLogP3 | 6.7 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 20 |
Exact Mass | 407.31644595 g/mol |
Monoisotopic Mass | 407.31644595 g/mol |
Topological Polar Surface Area | 58.6 Ų |
Heavy Atom Count | 27 |
Formal Charge | 0 |
Complexity | 363 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Impavido |
PubMed Health | miltefosine |
Drug Classes | Anti-Infective Agent |
Active Ingredient | Miltefosine |
2 of 2 | |
---|---|
Drug Name | Impavido |
PubMed Health | miltefosine |
Drug Classes | Anti-Infective Agent |
Active Ingredient | Miltefosine |
For the treatment of mucosal (caused by Leishmania braziliensis), cutaneous (caused by L. braziliensis, L. guyanensis, and L. panamensis), and visceral leishmaniasis (caused by L. donovani). In comparing Leishmania drug susceptibility, it has been found that L. donovani is the most susceptible to miltefosine while L. major is the least susceptible. Off-label use includes treatment of free-living amebae (FLA) infections (unlabeled use; CDC, 2013).
FDA Label
Little is known about the clinical pharmacodynamics of miltefosine and other antileishmanial drugs.
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.)
Antiprotozoal Agents
Substances that are destructive to protozoans. (See all compounds classified as Antiprotozoal Agents.)
Antineoplastic Agents
Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)
P - Antiparasitic products, insecticides and repellents
P01 - Antiprotozoals
P01C - Agents against leishmaniasis and trypanosomiasis
P01CX - Other agents against leishmaniasis and trypanosomiasis
P01CX04 - Miltefosine
Absorption
After oral administration, miltefosine is slowly absorbed from the gastrointestinal tract with an absolute bioavailability of 82% in rats and 94% in dogs. Absolute bioavailability has not been assessed in humans, however GI absorption rate in a two-compartment model is estimated to be 0.416 hr-1.
Route of Elimination
Miltefosine is almost completely eliminated by degradation via phospholipase D. Drug keeps accumulating until the end of treatment due to the extremely slow elimination, as seen by the long elimination half lives.
Volume of Distribution
Radioactivity studies have found that miltefosine has a wide distribution with high levels in the kidney, intestinal mucosa, liver, and spleen.
Clearance
Plasma clearance is very low and the terminal elimination half life was found to be 84 and 159 hours in rats and dogs respectively.
Miltefosine is metabolized mainly by phospholipase D, releasing choline, choline-containing metabolites, and hexadecanol, which are likely to enter the intermediary metabolism. The metabolites produced by this reaction are all endogenous and are likely used for bio-synthesis of acetylcholine, cell membranes, and long-chain fatty acids.
The primary elimination half life is 7.05 days (range: 5.45-9.10 days) and the terminal half-life is 30.9 days (range: 30.8-31.2 days).
Miltefosine has demonstrated activity against Leishmania parasites and neoplastic cells primarily due to its effects on apoptosis and disturbance of lipid-dependent cell signalling pathways. Several potential antileishmanial mechanisms of action have been proposed, however no mechanism has been identified definitely. Within the mitochondria, miltefosine inhibits cytochrome-c oxidase leading to mitochondrial dysfunction and apoptosis-like cell death. Antineoplastic mechanisms of action are related to antileishmanial targets and include inhibition of phosphatidylcholine biosynthesis and inhibition of Akt (also known as protein kinase B), which is a crucial protein within the PI3K/Akt/mTOR intracellular signalling pathway involved in regulating the cell cycle. Animal studies also suggest it may be effective against Trypanosome cruzi (the organism responsible for Chagas' disease), metronidazole-resistant strains of Trichonomas vaginalis, and it may have broad-spectrum anti-fungal activity.
Details:
Miltefosine is an oral anti-infective and one of the medicines with established efficacy in the treatment of some forms of leishmaniasis, a parasitic infection spread by sandflies.
Lead Product(s): Miltefosine
Therapeutic Area: Infections and Infectious Diseases Brand Name: Impavido
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 10, 2022
Lead Product(s) : Miltefosine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Miltefosine is an oral anti-infective and one of the medicines with established efficacy in the treatment of some forms of leishmaniasis, a parasitic infection spread by sandflies.
Product Name : Impavido
Product Type : Small molecule
Upfront Cash : Not Applicable
February 10, 2022
Details:
Miltefosine is an alkyllysophospholipid analogue drug with in vitro activity against the promastigote and amastigote stages of Leishmania species. Leishmaniasis is a parasitic disease that is found in parts of the tropics, subtropics, and southern Europe.
Lead Product(s): Miltefosine
Therapeutic Area: Infections and Infectious Diseases Brand Name: Impavido
Study Phase: UndisclosedProduct Type: Small molecule
Sponsor: Knight Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2021
Lead Product(s) : Miltefosine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Knight Therapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Miltefosine is an alkyllysophospholipid analogue drug with in vitro activity against the promastigote and amastigote stages of Leishmania species. Leishmaniasis is a parasitic disease that is found in parts of the tropics, subtropics, and southern Europ...
Product Name : Impavido
Product Type : Small molecule
Upfront Cash : Not Applicable
November 08, 2021
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ABOUT THIS PAGE
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PharmaCompass offers a list of Miltefosine 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 Miltefosine manufacturer or Miltefosine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Miltefosine manufacturer or Miltefosine supplier.
PharmaCompass also assists you with knowing the Miltefosine API Price utilized in the formulation of products. Miltefosine API Price is not always fixed or binding as the Miltefosine Price is obtained through a variety of data sources. The Miltefosine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Miltefosine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Miltefosine, including repackagers and relabelers. The FDA regulates Miltefosine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Miltefosine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Miltefosine supplier is an individual or a company that provides Miltefosine active pharmaceutical ingredient (API) or Miltefosine finished formulations upon request. The Miltefosine suppliers may include Miltefosine API manufacturers, exporters, distributors and traders.
Miltefosine 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 Miltefosine 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 Miltefosine GMP manufacturer or Miltefosine GMP API supplier for your needs.
A Miltefosine CoA (Certificate of Analysis) is a formal document that attests to Miltefosine's compliance with Miltefosine specifications and serves as a tool for batch-level quality control.
Miltefosine CoA mostly includes findings from lab analyses of a specific batch. For each Miltefosine 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.
Miltefosine may be tested according to a variety of international standards, such as European Pharmacopoeia (Miltefosine EP), Miltefosine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Miltefosine USP).