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

Stem definition	Drug id	CAS RN
cytostatic	1810	58066-85-6

Description:

Molecule

Description

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:

Dose	Unit	Route
0.15	g	O

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
March 19, 2014	FDA	KNIGHT THERAPS

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug ineffective for unapproved indication	93.00	68.32	25	319	23690	34932897

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug ineffective for unapproved indication	120.34	60.91	33	481	51205	79692669
Off label use	88.54	60.91	60	454	907155	78836719
Drug ineffective	70.13	60.91	56	458	1080857	78663017

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	1.29	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
RAC-alpha serine/threonine-protein kinase	Kinase	P31749	AKT1_HUMAN		IC50	5.02		CHEMBL
Dual specificity phosphatase Cdc25A	Enzyme	P30304	MPIP1_HUMAN		IC50	4.60		CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
IMPAVIDO	HUMAN PRESCRIPTION DRUG LABEL	1	69051-300	CAPSULE	50 mg	ORAL	NDA	31 sections
IMPAVIDO	HUMAN PRESCRIPTION DRUG LABEL	1	69051-300	CAPSULE	50 mg	ORAL	NDA	31 sections