30 completed, 5 unknown, 3 not yet recruiting, 2 recruiting. 23 Phase 2, 14 Phase 3, 3 Phase 1, 1 Early Phase 1, 1 Phase 4.
Follow miltefosine: new trials by email Literature Review of miltefosine trials Research Report on miltefosine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL) Sodium Stibogluconate (SSG), Miltefosine, Miltefosine + Paromomycin - Cutaneous Leihmaniasis | Phase 3 | Not yet recruiting | Institute of Tropical Medicine, Belgium | 900 | 2027-01-01 | 2026-03-10 |
| A Clinical Trial to Investigate Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Oral Regimens and Oral Miltefosine as Active Control in Participants Aged ≥ 18 Years Old With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR). LXE408, Miltefosine 50 MG Oral Capsule [Impavido], Placebo to LXE408 - Localized Cutaneous Leishmaniasis | Phase 2 | Not yet recruiting | Drugs for Neglected Diseases | 250 | 2026-06-15 | 2026-05-05 |
| Pilot Study: Miltefosine Gel (G-MTF) in Patients With Cutaneous Leishmaniasis MILTEFOSINE gel - Cutaneous Leishmaniasis, Cutaneous Leishmaniasis, American | Phase 1 | Not yet recruiting | Universidad Industrial de Santander | 15 | 2026-01-01 | 2025-09-08 |
| Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis With Inhaled Pentamidine Plus Oral Miltefosine Miltefosine Oral Capsule - Mucosal Leishmaniasis | Phase 2 | Recruiting | Fundacion Nacional de Dermatologia | 30 | 2025-02-04 | 2025-02-26 |
| OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients Miltefosine - Cutaneous Leishmaniases | Recruiting | Institute of Tropical Medicine, Belgium | 80 | 2024-06-18 | 2024-07-23 | |
| Repurposing Ivermectin for PKDL Treatment Ivermectin 6 Mg Oral Tablet, Miltefosine Oral Capsule - Post-kala-azar Dermal Leishmaniasis | Early Phase 1 | Completed | International Centre for Diarrhoeal Disease Research, Bangladesh | 30 | 2023-10-30 | 2025-09-10 |
| Randomised Clinical Trial in Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan drug: miltefosine with thermotherapy - Old World Cutaneous Leishmaniasis | Phase 3 | Completed | Medecins Sans Frontieres, Netherlands | 645 | 2022-10-07 | 2026-07-30 |
| Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly Miltefosine 50mg, Pentoxifylline 400mg, Liposomal Amphotericin B - Leishmaniasis; Brazilian, Leishmaniasis, Mucocutaneous | Phase 2 / Phase 3 | Unknown | University of Brasilia | 100 | 2022-06-22 | 2023-09-15 |
| Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World Meglumine Antimoniate, Miltefosine, Thermotherapy machine - Cutaneous Leishmaniases | Phase 3 | Completed | Drugs for Neglected Diseases | 184 | 2021-01-26 | 2025-05-08 |
| Outcomes of Complicated CL in Ethiopia Treated With Miltefosine Miltefosine (administration is not part of study procedures) - Cutaneous Leishmaniases | Completed | Institute of Tropical Medicine, Belgium | 94 | 2019-05-07 | 2020-06-25 | |
| Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis Miltefosine and Paromomycin, miltefosine, paromomycin - Cutaneous Leishmaniasis, American | Phase 2 / Phase 3 | Completed | Fundacion Nacional de Dermatologia | 120 | 2019-02-01 | 2021-02-02 |
| Short Course Regimens for Treatment of PKDL (Sudan) Paromomycin, Ambisome, Miltefosine - PKDL - Post-Kala-Azar Dermal Leishmanioid | Phase 2 | Unknown | Drugs for Neglected Diseases | 110 | 2018-05-09 | 2020-01-18 |
| Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa Miltefosine, Paromomycin, Sodium stibogluconate - Visceral Leishmaniasis | Phase 3 | Completed | Drugs for Neglected Diseases | 439 | 2018-01-24 | 2024-02-29 |
| Miltefosine and GM-CSF in Cutaneous Leishmaniasis Sbv, Miltefosine plus placebo, Miltefosine plus GM-CSF - Cutaneous Leishmaniasis | Phase 3 | Completed | Hospital Universitário Professor Edgard Santos | 300 | 2017-06-30 | 2020-04-07 |
| Thermotherapy + a Short Course of Miltefosine for the Treatment of Uncomplicated Cutaneous Leishmaniasis in the New World¨ Miltefosine - Cutaneous Leishmaniasis | Phase 2 | Completed | Drugs for Neglected Diseases | 130 | 2016-12-01 | 2019-09-12 |
| Miltefosine Plus IL Pentamidine for Bolivian CL miltefosine plus intralesional pentamidine - Leishmaniasis, Cutaneous | Phase 2 | Completed | Jonathan Berman | 50 | 2016-01-31 | 2018-02-27 |
| Dedicated QT Study in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis Miltefosine - Mucocutaneous Leishmaniasis | Completed | Knight Therapeutics (USA) Inc | 42 | 2015-12-01 | 2020-09-04 | |
| The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil Meglumine antimoniate, Miltefosine, Pentoxifylline - Leishmaniasis | Phase 2 | Unknown | University of Brasilia | 160 | 2015-08-01 | 2024-01-16 |
| Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry Miltefosine - Leishmaniasis | Withdrawn | Knight Therapeutics (USA) Inc | 2015-07-01 | 2020-08-28 | ||
| Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry Miltefosine - Leishmaniasis or Other Uses of Miltefosine | Withdrawn | Knight Therapeutics (USA) Inc | 2015-07-01 | 2025-04-27 |
Showing 20 of 44. Sign in to see all of them.
Leishmaniasis, Cutaneous (18) · Leishmaniasis (16) · Leishmaniasis, Visceral (10) · Leishmaniasis, Mucocutaneous (8) · Hyperthermia (2) · Chronic Urticaria (1) · Urticaria (1)
Drugs for Neglected Diseases (10) · Knight Therapeutics (USA) Inc (5) · AB Foundation (4) · Banaras Hindu University (3) · Institute of Tropical Medicine, Belgium (3) · Centro Internacional de Entrenamiento e Investigaciones Médicas (2) · Foundation Fader (2) · Fundacion Nacional de Dermatologia (2) · Hospital Universitário Professor Edgard Santos (2) · International Centre for Diarrhoeal Disease Research, Bangladesh (2) · University of Brasilia (2) · Brasilia University Hospital (1) · Centro de Investigaciones Bioclínicas de la Fundación Fader (1) · Jonathan Berman (1) · Marcus Maurer (1)
Bolivia (11) · Brazil (7) · Ethiopia (5) · India (5) · Colombia (4) · Bangladesh (3) · Kenya (3) · Sudan (3) · United States (3) · Panama (2) · Peru (2) · Uganda (2) · Germany (1) · Pakistan (1)
Jaime Soto, MD (3) · Shyam Sundar, MD (3) · Janet Ransom, PhD (2) · Paulo RL Machado, MD, PhD (2) · Ahmed M Musa, MD, Prof (1) · Alejandro Llanos-Cuentas, MD, PhD (1) · Cristian Blanco, PhD (1) · Dinesh Mondal, MBBS,MD,PhD (1) · Dr. Rashid Juma, MD (1) · Edgar M Carvalho, MD, PhD (1) · Ermias Diro, Dr. MD (1) · Farrokh Modabber (1) · Fiorela Yuly Alvarez Romero (1) · Gerson Penna, MD, PhD (1) · Glaucia Cota (1)
PMID 28379954, PMID 11353640, PMID 18781879, PMID 21129762, PMID 21200420, PMID 21255828, PMID 21718522, PMID 22238470, PMID 22594858, PMID 23740007, PMID 26573827, PMID 27188804, PMID 27627654, PMID 27927991, PMID 27956421, PMID 28558062, PMID 30188978, PMID 30653490, PMID 30789910, PMID 30815688, PMID 32894278, PMID 33253864, PMID 34048461, PMID 35255096, PMID 36164254, PMID 36395328, PMID 37988402, PMID 39007942