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Miltefosine

Generic Name
Miltefosine
Brand Names
Impavido
Drug Type
Small Molecule
Chemical Formula
C21H46NO4P
CAS Number
58066-85-6
Unique Ingredient Identifier
53EY29W7EC

Overview

Miltefosine is a broad spectrum antimicrobial, anti-leishmanial, phospholipid drug that was originally developed in the 1980s as an anti-cancer agent. It is currently the only recognized oral agent used to treat visceral, cutaneous, and mucosal forms of leishmaniasis, a neglected tropical disease. It can be administered topically or orally and is only indicated in patients aged 12 years or older. The CDC has also recommended it as a first line treatment for free-living amebae (FLA) infections such as primary amebic meningoencephalitis and granulomatous amebic encephalitis.

Background

Miltefosine is a broad spectrum antimicrobial, anti-leishmanial, phospholipid drug that was originally developed in the 1980s as an anti-cancer agent. It is currently the only recognized oral agent used to treat visceral, cutaneous, and mucosal forms of leishmaniasis, a neglected tropical disease. It can be administered topically or orally and is only indicated in patients aged 12 years or older. The CDC has also recommended it as a first line treatment for free-living amebae (FLA) infections such as primary amebic meningoencephalitis and granulomatous amebic encephalitis.

Indication

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).

Associated Conditions

  • Cutaneous Leishmaniasis
  • Mucocutaneous Leishmaniasis
  • Specific infections by free-living amoebae
  • Visceral Leishmaniasis

Clinical Trials

Recruiting
Posted: 2024/07/23
Sponsor:
Institute of Tropica...
Early Phase 1
Recruiting
Posted: 2024/02/09
Phase 3
Recruiting
Posted: 2021/03/16
Sponsor:
Fundacion Nacional d...

FDA Approved Products

IMPAVIDO
Manufacturer:Profounda, Inc.
Route:ORAL
Strength:50 mg in 1 1
Approved: 2023/08/11
NDC:69051-300

Singapore Approved Products

No Singapore products found for this drug

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