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 indica...
- 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...
- Associated Conditions
- Cutaneous Leishmaniasis, Mucocutaneous Leishmaniasis, Specific infections by free-living amoebae, Visceral Leishmaniasis
- Associated Therapies
- -
OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients
- First Posted Date
- 2024-07-23
- Last Posted Date
- 2024-07-23
- Lead Sponsor
- Institute of Tropical Medicine, Belgium
- Target Recruit Count
- 80
- Registration Number
- NCT06514560
- Locations
- 🇪🇹
Africa Leprosy, Tuberculosis, Rehabilitation and Training (ALERT) Hospital, Addis Abeba, Ethiopia
Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World
- Conditions
- Interventions
- First Posted Date
- 2020-08-17
- Last Posted Date
- 2024-02-22
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 184
- Registration Number
- NCT04515186
- Locations
- 🇧🇷
Julio Muller University Hospital Federal University of Mato Grosso, Cuiaba, Brazil
🇧🇷Federal University of Bahia Immunology Department, Salvador, Brazil
🇵🇪Universidad Peruana Cayetano Heredia, Lima, Peru
Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis
- Conditions
- Interventions
- First Posted Date
- 2019-02-04
- Last Posted Date
- 2021-02-02
- Lead Sponsor
- Fundacion Nacional de Dermatologia
- Target Recruit Count
- 120
- Registration Number
- NCT03829917
- Locations
- 🇧🇴
Hopital, Dermatologico, Jorochito, SC, Bolivia
Short Course Regimens for Treatment of PKDL (Sudan)
- Conditions
- Interventions
- First Posted Date
- 2018-01-17
- Last Posted Date
- 2020-01-18
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 110
- Registration Number
- NCT03399955
- Locations
- 🇸🇩
Prof. Elhassan Centre for tropical Medicine, Doka, Gedaref, Sudan
Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa
- Conditions
- Interventions
- First Posted Date
- 2017-04-26
- Last Posted Date
- 2024-02-29
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 439
- Registration Number
- NCT03129646
- Locations
- 🇪🇹
Abdurafi MSF Health Center, Ābderafī, Amhara, Ethiopia
🇸🇩El Hassan Centre for Tropical Medicine, Doka, Gedaref, Sudan
🇰🇪Kacheliba Hospital, Kapenguria, West Pokot, Kenya
Thermotherapy + a Short Course of Miltefosine for the Treatment of Uncomplicated Cutaneous Leishmaniasis in the New World¨
- First Posted Date
- 2016-02-23
- Last Posted Date
- 2019-09-12
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 130
- Registration Number
- NCT02687971
- Locations
- 🇵🇪
IMT Alexander Von Humboldt, Lima, Peru
🇨🇴Programa de Estudios y Control de Enfermedades Tropicales (PECET), Universidad de Antioquia, Medellin, Colombia
The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil
- Conditions
- Interventions
- First Posted Date
- 2015-08-21
- Last Posted Date
- 2024-01-16
- Lead Sponsor
- University of Brasilia
- Target Recruit Count
- 160
- Registration Number
- NCT02530697
- Locations
- 🇧🇷
Hospital Universitário de Brasília, Brasília, DF, Brazil
Spermiogram Assessment in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
- First Posted Date
- 2015-05-01
- Last Posted Date
- 2019-03-04
- Lead Sponsor
- Knight Therapeutics (USA) Inc
- Target Recruit Count
- 55
- Registration Number
- NCT02431429
- Locations
- 🇧🇴
Funderama, Santa Cruz, Bolivia
Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa
- First Posted Date
- 2015-04-30
- Last Posted Date
- 2016-10-11
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 30
- Registration Number
- NCT02431143
- Locations
- 🇺🇬
Amudat Hospital, Amudat, Karamoja, Uganda
🇰🇪Kacheliba Hospital, Kacheliba, Rift Valley, West Pokot, Kenya
Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
- First Posted Date
- 2015-04-29
- Last Posted Date
- 2020-08-28
- Lead Sponsor
- Knight Therapeutics (USA) Inc
- Registration Number
- NCT02429505
- Locations
- 🇺🇸
Fast-Track Drugs and Biologics, LLC, Poolesville, Maryland, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.