Miltefosine

Generic Name: Miltefosine

Brand Names: Impavido

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₄₆NO_₄P

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: -

Clinical Trials

Dedicated QT Study in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis

Completed

Conditions: Mucocutaneous Leishmaniasis

Interventions: Drug: Miltefosine

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

Recruiting

Conditions: Leishmaniasis or Other Uses of Miltefosine

Interventions: Drug: Miltefosine

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

Phase 3

Completed

Conditions: Post Kala Azar Dermal Leishmaniasis

Interventions: Drug: Miltefosine

First Posted Date: 2014-07-17

Last Posted Date: 2019-08-21

Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

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.

Phase 3

Completed

Conditions: Visceral Leishmaniasis

Interventions: Drug: Liposomal Amphotericin B
Drug: Miltefosine

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)

Phase 2

Completed

Conditions: PKDL

Interventions: Drug: Miltefosine

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

Phase 4

Completed

Conditions: Cutaneous Leishmaniasis

Interventions: Drug: Miltefosine

First Posted Date: 2011-10-31

Last Posted Date: 2016-08-22

Lead Sponsor: Centro Internacional de Entrenamiento e Investigaciones Médicas

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

Phase 2

Completed

Conditions: Leishmaniasis
Leishmaniasis, Mucocutaneous

Interventions: Drug: Standard Treatment Meglumine antimoniate
Drug: Miltefosine

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

Phase 2

Terminated

Conditions: Chronic Urticaria

Interventions: Drug: Placebo
Drug: Miltefosine

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

Phase 2

Completed

Conditions: Primary Visceral Leishmaniasis

Interventions: Drug: Liposomal amphotericin B + miltefosine
Drug: Liposomal amphotericin B (AmBisome®) and sodium stibogluconate
Drug: Miltefosine

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

Phase 2

Completed

Conditions: Cutaneous Leishmaniasis
Mucosal Leishmaniasis

Interventions: Drug: Miltefosine

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

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy