miltefosine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
cytostatic 1810 58066-85-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • impavido
  • miltefosine
  • hexadecylphosphocholine
  • hexadecylphosphorylcholine
  • miltefos
hexadecyl phosphocholine derivative of cisplatin; did not substantially activate HIV long terminal repeat; less toxic than cisplatin
  • Molecular weight: 407.58
  • Formula: C21H46NO4P
  • CLOGP: -2.38
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 0
  • TPSA: 58.59
  • ALOGS: -6.32
  • ROTB: 20

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
March 19, 2014 FDA KNIGHT THERAPS

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective for unapproved indication 77.44 66.58 19 239 14195 29560074

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective for unapproved indication 95.84 63.04 25 403 31108 64467196
Off label use 75.49 63.04 48 380 632758 63865546

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC P01CX04 ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS
ANTIPROTOZOALS
AGENTS AGAINST LEISHMANIASIS AND TRYPANOSOMIASIS
Other agents against leishmaniasis and trypanosomiasis
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000935 Antifungal Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D000977 Antiparasitic Agents
MeSH PA D000981 Antiprotozoal Agents
FDA EPC N0000190851 Antileishmanial
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:35718 antifungal agents
CHEBI has role CHEBI:35820 antiprotozoal drugs
CHEBI has role CHEBI:37699 protein kinase inhibitors
CHEBI has role CHEBI:50846 Immunologic factor
CHEBI has role CHEBI:67079 anti-inflammatory agents
CHEBI has role CHEBI:68495 Type I cell-death inducers
CHEBI has role CHEBI:149553 anticoronaviral drug

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Visceral leishmaniasis indication 186803007 DOID:9146
Cutaneous leishmaniasis indication 240637006 DOID:9111
American mucocutaneous leishmaniasis indication 403135004
Sjogren-Larsson syndrome contraindication 111303009 DOID:14501
Pregnancy, function contraindication 289908002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 1.29 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
RAC-alpha serine/threonine-protein kinase Kinase IC50 5.02 CHEMBL
Dual specificity phosphatase Cdc25A Enzyme IC50 4.60 CHEMBL

External reference:

IDSource
D02494 KEGG_DRUG
4035630 VANDF
C0068006 UMLSCUI
CHEBI:75283 CHEBI
CHEMBL125 ChEMBL_ID
DB09031 DRUGBANK_ID
C039128 MESH_SUPPLEMENTAL_RECORD_UI
3599 PUBCHEM_CID
11355 IUPHAR_LIGAND_ID
6362 INN_ID
53EY29W7EC UNII
1494066 RXNORM
213400 MMSL
25615 MMSL
d07564 MMSL
006585 NDDF
713642004 SNOMEDCT_US
713676008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
IMPAVIDO HUMAN PRESCRIPTION DRUG LABEL 1 69051-300 CAPSULE 50 mg ORAL NDA 30 sections