{"disease":{"id":"cutaneous-leishmaniasis","name":"Cutaneous leishmaniasis","therapeutic_area":"","data":{},"enrichment_level":0,"last_enriched_at":null,"visit_count":0,"created_at":"2026-04-19T18:31:21.150Z","updated_at":"2026-04-19T18:39:44.960Z","meddra_pt":null,"meddra_code":null,"icd10_codes":null,"synonyms":[],"prevalence_global":null,"prevalence_us":null,"marketed_drug_count":1,"pipeline_drug_count":0,"trial_count":1},"drugs":{"marketed":[{"drug_id":"miltefosine","indication_name":"American mucocutaneous leishmaniasis","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":"Impavido","generic_name":"MILTEFOSINE","company_name":"Knight Theraps","drug_phase":"marketed","molecular_target":"RAC-alpha serine/threonine-protein kinase","drug_class":"Antileishmanial [EPC]","quality_score":65,"revenue":null,"mechanism":"Impavido works by inhibiting the RAC-alpha serine/threonine-protein kinase, which is essential for the survival of Leishmania parasites."},{"drug_id":"miltefosine","indication_name":"Cutaneous leishmaniasis","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":"Impavido","generic_name":"MILTEFOSINE","company_name":"Knight Theraps","drug_phase":"marketed","molecular_target":"RAC-alpha serine/threonine-protein kinase","drug_class":"Antileishmanial [EPC]","quality_score":65,"revenue":null,"mechanism":"Impavido works by inhibiting the RAC-alpha serine/threonine-protein kinase, which is essential for the survival of Leishmania parasites."}],"pipeline":[],"offLabel":[],"totalMarketed":2,"totalPipeline":0},"trials":{"data":[{"nct_id":"NCT07506967","title":"Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers","phase":"NA","overall_status":"NOT_YET_RECRUITING","enrollment_count":2420,"lead_sponsor_name":"Kenya Medical Research Institute","has_results":false},{"nct_id":"NCT00344084","title":"Surveillance for Leishmaniasis Skin Lesions in Mali","phase":"","overall_status":"COMPLETED","enrollment_count":1593,"lead_sponsor_name":"National Institute of Allergy and Infectious Diseases (NIAID)","has_results":false},{"nct_id":"NCT04268524","title":"Randomised Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan","phase":"PHASE3","overall_status":"RECRUITING","enrollment_count":832,"lead_sponsor_name":"Medecins Sans Frontieres, Netherlands","has_results":false},{"nct_id":"NCT03023111","title":"Miltefosine and GM-CSF in Cutaneous Leishmaniasis","phase":"PHASE3","overall_status":"COMPLETED","enrollment_count":300,"lead_sponsor_name":"Hospital Universitário Professor Edgard Santos","has_results":false},{"nct_id":"NCT06692985","title":"Epidemiology of Cutaneous Leishmaniasis in Niger, Mali, Togo : Mapping of Clinical Cases, Species, Reservoirs and Vectors of the Disease","phase":"","overall_status":"COMPLETED","enrollment_count":270,"lead_sponsor_name":"Centre Hospitalier de Cayenne","has_results":false},{"nct_id":"NCT06997159","title":"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).","phase":"PHASE2","overall_status":"NOT_YET_RECRUITING","enrollment_count":250,"lead_sponsor_name":"Drugs for Neglected Diseases","has_results":false},{"nct_id":"NCT07504757","title":"LEISH-PED: Study on Leishmaniasis in Children","phase":"","overall_status":"RECRUITING","enrollment_count":200,"lead_sponsor_name":"Meyer Children's Hospital IRCCS","has_results":false},{"nct_id":"NCT06746350","title":"Feasibility of Integrating Thermotherapy for Treatment of Cutaneous Leishmaniasis in Primary Health Care Setup","phase":"NA","overall_status":"NOT_YET_RECRUITING","enrollment_count":165,"lead_sponsor_name":"Armauer Hansen Research Institute, Ethiopia","has_results":false},{"nct_id":"NCT04500873","title":"Performance of RPA-LF for Cutaneous Leishmaniasis","phase":"","overall_status":"COMPLETED","enrollment_count":128,"lead_sponsor_name":"Centro Internacional de Entrenamiento e Investigaciones Médicas","has_results":false},{"nct_id":"NCT03829917","title":"Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis","phase":"PHASE2, PHASE3","overall_status":"COMPLETED","enrollment_count":120,"lead_sponsor_name":"Fundacion Nacional de Dermatologia","has_results":false},{"nct_id":"NCT04699383","title":"Documentation of Patient Outcomes for SSG/Allopurinol Combination Treatment in Ethiopia","phase":"","overall_status":"COMPLETED","enrollment_count":105,"lead_sponsor_name":"Institute of Tropical Medicine, Belgium","has_results":false},{"nct_id":"NCT05533736","title":"Feasibility and Usability of Mobile Applications for Monitoring Cutaneous Leishmaniasis Treatment in Colombia","phase":"NA","overall_status":"COMPLETED","enrollment_count":105,"lead_sponsor_name":"Centro Internacional de Entrenamiento e Investigaciones Médicas","has_results":false},{"nct_id":"NCT06798402","title":"Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate","phase":"PHASE2","overall_status":"RECRUITING","enrollment_count":80,"lead_sponsor_name":"Al-Mustafa University College","has_results":false},{"nct_id":"NCT03096457","title":"Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia","phase":"PHASE2, PHASE3","overall_status":"COMPLETED","enrollment_count":80,"lead_sponsor_name":"Fundacion Nacional de Dermatologia","has_results":false},{"nct_id":"NCT06798415","title":"Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis","phase":"PHASE2","overall_status":"RECRUITING","enrollment_count":40,"lead_sponsor_name":"Hayder Adnan Fawzi","has_results":false},{"nct_id":"NCT06797544","title":"Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis","phase":"PHASE2","overall_status":"RECRUITING","enrollment_count":40,"lead_sponsor_name":"Hayder Adnan Fawzi","has_results":false},{"nct_id":"NCT06449040","title":"Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly","phase":"PHASE1, PHASE2","overall_status":"COMPLETED","enrollment_count":28,"lead_sponsor_name":"Hospital Universitário Professor Edgard Santos","has_results":false},{"nct_id":"NCT06011343","title":"Tofacitinib Associated With Meglumine Antimoniate in Cutaneous Leishmaniasis","phase":"PHASE2, PHASE3","overall_status":"UNKNOWN","enrollment_count":22,"lead_sponsor_name":"Hospital Universitário Professor Edgard Santos","has_results":false},{"nct_id":"NCT06000514","title":"Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis.","phase":"PHASE1, PHASE2","overall_status":"COMPLETED","enrollment_count":20,"lead_sponsor_name":"Hospital Universitário Professor Edgard Santos","has_results":false},{"nct_id":"NCT07149753","title":"Pilot Study: Miltefosine Gel (G-MTF) in Patients With Cutaneous Leishmaniasis","phase":"PHASE1","overall_status":"NOT_YET_RECRUITING","enrollment_count":15,"lead_sponsor_name":"Universidad Industrial de Santander","has_results":false},{"nct_id":"NCT00657917","title":"Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396","phase":"PHASE2","overall_status":"TERMINATED","enrollment_count":1,"lead_sponsor_name":"U.S. Army Medical Research and Development Command","has_results":true},{"nct_id":"NCT00508963","title":"Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis","phase":"","overall_status":"NO_LONGER_AVAILABLE","enrollment_count":null,"lead_sponsor_name":"University of California, San Francisco","has_results":false}],"total":22},"guidelines":[],"source":"Drug Landscape verified database"}