Miltefosine
- Generic Name
- Miltefosine
- Brand Names
- Impavido
- Drug Type
- Small Molecule
- Chemical Formula
- C21H46NO4P
- CAS Number
- 58066-85-6
- Unique Ingredient Identifier
- 53EY29W7EC
- 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
- Associated Therapies
- -
Dedicated QT Study in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
- First Posted Date
- 2015-04-29
- Last Posted Date
- 2020-09-04
- Lead Sponsor
- Knight Therapeutics (USA) Inc
- Target Recruit Count
- 42
- Registration Number
- NCT02429518
- Locations
- 🇧🇴
Funderma, Santa Cruz, Bolivia
Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry
- First Posted Date
- 2015-04-28
- Last Posted Date
- 2018-03-07
- Lead Sponsor
- Knight Therapeutics (USA) Inc
- Target Recruit Count
- 2
- Registration Number
- NCT02427308
- Locations
- 🇺🇸
Fast Track, North Potomac, Maryland, United States
Miltefosine for Children With PKDL
- First Posted Date
- 2014-07-17
- Last Posted Date
- 2019-08-21
- Target Recruit Count
- 80
- Registration Number
- NCT02193022
- Locations
- 🇧🇩
International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh
Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients.
- Conditions
- Interventions
- First Posted Date
- 2013-12-16
- Last Posted Date
- 2019-04-08
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 59
- Registration Number
- NCT02011958
- Locations
- 🇪🇹
MSF, Abdurafi, Ethiopia
🇪🇹Leishmaniasis Research Center, University Hospital of Gondar, Gondar, Ethiopia
Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)
- First Posted Date
- 2012-07-10
- Last Posted Date
- 2012-07-10
- Lead Sponsor
- AB Foundation
- Target Recruit Count
- 37
- Registration Number
- NCT01635777
- Locations
- 🇮🇳
Institute of Medical Sciences, Banaras Hindu University,, Varanasi, India
Pharmacokinetics of Miltefosine in Children and Adults
- First Posted Date
- 2011-10-31
- Last Posted Date
- 2016-08-22
- Target Recruit Count
- 60
- Registration Number
- NCT01462500
- Locations
- 🇨🇴
Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas, Cali, Valle, Colombia
Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis
- Conditions
- Interventions
- First Posted Date
- 2011-06-22
- Last Posted Date
- 2015-06-09
- Lead Sponsor
- Brasilia University Hospital
- Target Recruit Count
- 40
- Registration Number
- NCT01377974
- Locations
- 🇧🇷
Brasilia University Hospital, Brasilia, DF, Brazil
Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria
- First Posted Date
- 2010-07-28
- Last Posted Date
- 2016-12-26
- Lead Sponsor
- Marcus Maurer
- Target Recruit Count
- 76
- Registration Number
- NCT01170949
- Locations
- 🇩🇪
Charité University, Berlin, Germany
Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa
- First Posted Date
- 2010-02-11
- Last Posted Date
- 2017-04-24
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 151
- Registration Number
- NCT01067443
- Locations
- 🇰🇪
Kimalel Health Centre, Kimalel, Kenya
🇸🇩Kassab Hospital, Kassab, Gedaref, Sudan
🇸🇩El Hassan Centre for Tropical Medicine, Doka, Gedarif, Sudan
Miltefosine to Treat Mucocutaneous Leishmaniasis
- Conditions
- Interventions
- First Posted Date
- 2010-01-18
- Last Posted Date
- 2020-09-30
- Lead Sponsor
- Knight Therapeutics (USA) Inc
- Target Recruit Count
- 4
- Registration Number
- NCT01050907
- Locations
- 🇺🇸
For this treatment IND, each Physician entered patients at his/her own facility. Below data is for protocol central contact:, Bethesda, Maryland, United States
🇺🇸NIH, Bethesda, Maryland, United States
Drug Development Updates
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