Leishmaniasis
diseaseOn this page
Also known as cutaneous leishmaniasis (subtype)visceral leishmaniasis (subtype)
Summary
Leishmaniasis (MONDO:0011989) is a disease and 32 clinical trials. Top therapeutic interventions include miltefosine, amphotericin b, and allopurinol. A subtype of protozoa infectious disease — broader associated-gene and molecular evidence is on the parent page (see Disease family below).
At a glance
- Prevalence: 1-9 / 1 000 000 (Europe) [Orphanet-validated]
- Phenotypes (HPO): 25
- Clinical trials: 32
Clinical features
Epidemiology
Prevalence records
2 prevalence record(s), Orphanet:
| Type | Class | Value | Geography | Validation |
|---|---|---|---|---|
| Annual incidence | 1-5 / 10 000 | 25 | Worldwide | Validated |
| Point prevalence | 1-9 / 1 000 000 | 0.1 | Europe | Validated |
Signs & symptoms
Clinical features (HPO)
25 HPO clinical features (Orphanet curated; top 25 by frequency):
| HPO ID | Term | Frequency |
|---|---|---|
| HP:0000163 | Abnormal oral cavity morphology | Very frequent (80-99%) |
| HP:0001744 | Splenomegaly | Very frequent (80-99%) |
| HP:0001876 | Pancytopenia | Very frequent (80-99%) |
| HP:0001892 | Abnormal bleeding | Very frequent (80-99%) |
| HP:0001954 | Recurrent fever | Very frequent (80-99%) |
| HP:0002240 | Hepatomegaly | Very frequent (80-99%) |
| HP:0002716 | Lymphadenopathy | Very frequent (80-99%) |
| HP:0004311 | Abnormal macrophage morphology | Very frequent (80-99%) |
| HP:0011830 | Abnormal oral mucosa morphology | Very frequent (80-99%) |
| HP:0012384 | Rhinitis | Very frequent (80-99%) |
| HP:0030166 | Night sweats | Very frequent (80-99%) |
| HP:0200034 | Papule | Very frequent (80-99%) |
| HP:0200035 | Skin plaque | Very frequent (80-99%) |
| HP:0200042 | Skin ulcer | Very frequent (80-99%) |
| HP:0000980 | Pallor | Frequent (30-79%) |
| HP:0001824 | Weight loss | Frequent (30-79%) |
| HP:0001903 | Anemia | Frequent (30-79%) |
| HP:0002829 | Arthralgia | Frequent (30-79%) |
| HP:0002910 | Elevated circulating hepatic transaminase concentration | Frequent (30-79%) |
| HP:0003073 | Hypoalbuminemia | Frequent (30-79%) |
| HP:0010702 | Increased circulating antibody level | Frequent (30-79%) |
| HP:0001873 | Thrombocytopenia | Occasional (5-29%) |
| HP:0001882 | Leukopenia | Occasional (5-29%) |
| HP:0002039 | Anorexia | Occasional (5-29%) |
| HP:0012378 | Fatigue | Occasional (5-29%) |
Identifiers
Disease identifiers
| Field | Value |
|---|---|
| Canonical name | leishmaniasis |
| Mondo ID | MONDO:0011989 |
| EFO | EFO:0005044 |
| MeSH | D007896 |
| Orphanet | 507 |
| DOID | DOID:9065 |
| ICD-10-CM | B55 |
| ICD-11 | 1082373067 |
| NCIT | C34767 |
| SNOMED CT | 80612004 |
| UMLS | C0023281 |
| MedGen | 9714 |
| GARD | 0006881 |
| MedDRA | 10024198 |
| NORD | 1895 |
| Is cancer (heuristic) | no |
Also known as: cutaneous leishmaniasis (subtype) · visceral leishmaniasis (subtype)
Disease family
This is a subtype of protozoa infectious disease. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.
Classification path: disease › human disease › disease by etiologic mechanism › disease of primarily extrinsic mechanism › infectious disease › parasitic infectious disease › protozoa infectious disease › leishmaniasis
Related subtypes (14): primary amebic meningoencephalitis, granulomatous amebic encephalitis, trypanosomiasis, giardiasis, protozoal dysentery, trichomoniasis, malaria, Acanthamoeba keratitis, amebiasis, babesiosis, balantidiasis, coccidiosis, theileriasis, dientamoebiasis
Subtypes (3): visceral leishmaniasis, cutaneous leishmaniasis, mucocutaneous leishmaniasis
Genetics & variants
GWAS landscape
No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.
Variant details and genetic-evidence tiers
No tiered GWAS variants or ClinVar records for this disease.
Genes & proteins
No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).
Function
No pathway enrichment — requires an associated-gene cohort.
Therapeutics
Drugs indicated for this disease
6 approved, 5 in late-stage (phase 3) trials. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.
| Drug | Development status |
|---|---|
| Acetarsone | Approved (phase 4) |
| Benznidazole | Approved (phase 4) |
| Fexinidazole | Approved (phase 4) |
| Miltefosine | Approved (phase 4) |
| Nifurtimox | Approved (phase 4) |
| Nitrofurazone | Approved (phase 4) |
| Amphotericin B | Phase 3 (in late-stage trials) |
| Eflornithine | Phase 3 (in late-stage trials) |
| Meglumine Antimonate | Phase 3 (in late-stage trials) |
| Melarsoprol | Phase 3 (in late-stage trials) |
| Voriconazole | Phase 3 (in late-stage trials) |
Earlier-phase candidates (phase 2, investigational — efficacy not yet established): Allopurinol, Gentamicin, Meglumine, Paromomycin, Pentamidine, Pentoxifylline.
Clinical trials & evidence
Clinical trials
Clinical trials: 32.
Phase distribution (across all retrieved trials)
| Phase | Trials |
|---|---|
| Not specified | 16 |
| PHASE2 | 7 |
| PHASE1 | 5 |
| PHASE1/PHASE2 | 4 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT02530697 | PHASE2 | ACTIVE_NOT_RECRUITING | The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil |
| NCT00004755 | PHASE2 | COMPLETED | Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil |
| NCT00373568 | PHASE1/PHASE2 | COMPLETED | Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis |
| NCT00373776 | PHASE1/PHASE2 | COMPLETED | Miltefosine for Mucosal Leishmaniasis |
| NCT00657618 | PHASE1/PHASE2 | COMPLETED | Use of Sodium Stibogluconate as a Treatment for Leishmaniasis |
| NCT00662012 | PHASE2 | COMPLETED | Sodium Stibogluconate Treatment of Leishmaniasis |
| NCT01300975 | PHASE2 | COMPLETED | Intralesional Antimony for Bolivian Cutaneous Leishmaniasis |
| NCT01377974 | PHASE2 | COMPLETED | Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis |
| NCT01437020 | PHASE1/PHASE2 | WITHDRAWN | SCH708980 With and Without AmBisome for Visceral Leishmaniasis |
| NCT02656797 | PHASE2 | COMPLETED | Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis |
| NCT03294161 | PHASE2 | COMPLETED | Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis |
| NCT01484548 | PHASE1 | COMPLETED | Phase 1 LEISH-F3 Vaccine Trial in Healthy Adult Volunteers |
| NCT01751048 | PHASE1 | COMPLETED | LEISH-F3 + GLA-SE and the LEISH-F3 + MPL-SE Vaccine |
| NCT03874234 | PHASE1 | TERMINATED | Safety, Tolerability and Pharmacokinetics (PKs) Investigation of GSK3186899 in Healthy Subjects |
| NCT04504435 | PHASE1 | TERMINATED | Safety, Tolerability and Pharmacokinetics (PK) Investigation of GSK3494245 in Healthy Participants |
| NCT06124144 | PHASE1 | TERMINATED | Safety and Drug Absorption of Orally Administered Oleylphosphocholine (OlPC) in Healthy Adults |
| NCT00344188 | Not specified | RECRUITING | Diagnosis and Treatment of Leishmania Infections |
| NCT03784248 | Not specified | ACTIVE_NOT_RECRUITING | Mediterranean Visceral Leishmaniasis With Leishmania Infantum |
| NCT06307171 | Not specified | RECRUITING | Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers |
| NCT06859619 | Not specified | NOT_YET_RECRUITING | Serological Measurement of Montpellier Professionals’ Contacts with Infectious Agents Responsible for Animal-borne Diseases |
| NCT07358910 | Not specified | RECRUITING | Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective |
| NCT00001169 | Not specified | COMPLETED | Clinical Investigation of Infections Due to Leishmanial Parasites |
| NCT00401297 | Not specified | COMPLETED | Th1/Th2 Polarization and Linkage to L. Viannia Infection Outcomes |
| NCT00401349 | Not specified | COMPLETED | Expression of Mif Alleles in Individuals With Leishmaniasis |
| NCT00401557 | Not specified | COMPLETED | Mechanisms Relating to the Distinct in Vitro Susceptibility of Human Macrophages to L. Viannia Infection |
| NCT02427308 | Not specified | WITHDRAWN | Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry |
| NCT02429505 | Not specified | WITHDRAWN | Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry |
| NCT03009422 | Not specified | UNKNOWN | Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis. |
| NCT03641339 | Not specified | COMPLETED | Defining Skin Immunity of a Bite of Key Insect Vectors in Humans |
| NCT03993093 | Not specified | COMPLETED | Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre |
| NCT04512742 | Not specified | COMPLETED | A Clinical Study to Develop a Controlled Human Infection Model Using Leishmania Major-infected Sand Flies |
| NCT05449717 | Not specified | COMPLETED | Incidence of Relapse and Post-Kala-Azar Dermal Leishmaniasis in South Sudan |
Drugs tested across these trials (top 30)
| Molecule | Max phase | Trials referencing |
|---|---|---|
| MILTEFOSINE | 4 | 5 |
| AMPHOTERICIN B | 4 | 2 |
| ALLOPURINOL | 4 | 1 |
| PENTOXIFYLLINE | 4 | 1 |
| SODIUM STIBOGLUCONATE | 4 | 1 |
| MEGLUMINE ANTIMONATE | 3 | 3 |
| ANTIMONY CATION (5+) | 3 | 1 |
| LEISH-F3 | 1 | 2 |
| GSK-3186899 | 1 | 1 |
| GSK-3494245 | 1 | 1 |
| OLEYLPHOSPHOCHOLINE | 1 | 1 |
| CHEMBL4537559 | 0 | 2 |
| CHEMBL454494 | 0 | 2 |
| CHEMBL2079699 | 0 | 1 |
| CHEMBL4444260 | 0 | 1 |