miltefosine (impavido) Report issue

Small molecule Orphan Drug FDA Approved FDA First in Class Fast Track FDA Priority Review FDA
AACT ChEMBL DrugBank Drug Central Drugs@FDA KEGG MeSH PubChem repoDB

Active Ingredient History

NOW
  • Now
Miltefosine is an anti-leishmanial agent. It is an alkyl phospholipids compound, was originally intended for breast cancer and other solid tumors. However, it could not be developed as an oral agent because of dose-limiting gastro-intestinal toxicity, and only a topical formulation is approved for skin metastasis. But Miltefosine showed excellent antileishmanial activity both in vitro and in experimental models. Miltefosine is effective in vitro against both promastigotes and amastigotes of various species of Leishmania and also other kinetoplastidae (Trypanosoma cruzi,T. brucei) and other protozoan parasites (Entamoeba histolytica, Acanthamoeba). Mechanism of action is unknown. It is likely to involve interaction with lipids (phospholipids and sterols), including membrane lipids, inhibition of cytochrome c oxidase (mitochondrial function), and apoptosis-like cell death. Miltefosine is approved for the treatment of Visceral leishmaniasis (due to Leishmania donovani), Cutaneous leishmaniasis (due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis) and Mucosal leishmaniasis (due to Leishmania braziliensis).   NCATS

Chemistry

  • SMILES: CCCCCCCCCCCCCCCCOP([O-])(=O)OCC[N+](C)(C)C
  • InChIKey: PQLXHQMOHUQAKB-UHFFFAOYSA-N
  • Mol. Mass: 407.568
  • ALogP: 5.68
  • ChEMBL Molecule:
    miltefosine  
More Chemistry

Pharmacology

  • Mechanism of Action:
  • Multi-specific: Missing data
  • Black Box: No
  • Availability: Prescription Only
  • Delivery Methods: Oral
  • Pro Drug: No

Alternative names

d18506 | d 18506 | d-18506 | ethanaminium, 2-(((hexadecyloxy)hydroxyphosphinyl)oxy)-n,n,n-trimethyl-, hydroxide, innner salt | hdpc | hexadecyl 2-(trimethylazaniumyl)ethyl phosphate | hexadecylphosphocholine | hexadecylphosphorylcholine | impavido | miltefos | miltefosin | miltefosina | miltefosine | miltéfosine | miltex | mitefosine | monohexadecylphosphocholine | monohexadecylphosphorylcholine | n-hexadecylphosphorylcholine | tf 002

Organizations (53)

Research & Development (53)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Marketing (1)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Overview

  • Highest Phase: Phase 4
  • # of Trials: 41
  • # of Trial Organizations: 53

Trials by Phase

Trial Phase Start Date Organizations Indications

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