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Infectious disease that is transmitted through the bite of hematophagous female phlebotomine sand flies. The clinical spectrum ranges from asymptomatic to clinically overt disease which can remain localized to the skin or disseminate to the upper oral and respiratory mucous membranes or throughout the reticulo-endothelial system. Three main clinical syndromes have been described: visceral (or Kala-Azar; with fever, weight loss, hepatosplenomegaly), cutaneous, and mucocutaneous leishmaniasis (cutaneous or mucocutaneous ulceration).
Biomarker and diagnostic research for leishmaniasis has been reported in the published literature.
1 FDA-approved treatment is available for leishmaniasis, including MILTEFOSINE (IMPAVIDO, approved 2014). An additional 2 compounds hold orphan drug designation.
Brand Name | Generic Name | Mechanism | Approved | Market Status |
|---|---|---|---|---|
Estimated prevalence: 1-9 in 1,000,000 (Rare).
28 clinical trials registered, 15 recruiting. Interventions under study include drug therapy, other interventions, and medical devices. Pipeline includes 3 PHASE3, 8 PHASE2, 2 PHASE1. Research is primarily sponsored by academic and government institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT06550609](https://clinicaltrials.gov/study/NCT06550609) |
Data assembled from 5 of 12 sources · Last updated Sep 20, 2026, 3:00 PM UTC
European rare disease database
Genetic and Rare Diseases Info Center
IMPAVIDO
MILTEFOSINE |
— |
2014 |
Available |
The following drugs have received orphan drug designation from the FDA for leishmaniasis. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor | Designated | Exclusivity End | Designation Status |
|---|---|---|---|---|---|
parasite-selective proteasome inhibitor with potent activity against kinetoplastid parasites | parasite-selective proteasome inhibitor with potent activity against kinetoplastid parasites | Novartis Pharmaceuticals Corporation | 2025 | — | Designated |
oleylphosphocholine | oleylphosphocholine | Oblita Therapeutics bvba | 2013 | — | Designated |
Gene therapy approaches for leishmaniasis have been reported in the published literature.
28 trials found
Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis With Inhaled Pentamidine Plus Oral Miltefosine |
PHASE2 |
Fundacion Nacional de Dermatologia |
RECRUITING |
[NCT07504757](https://clinicaltrials.gov/study/NCT07504757) | LEISH-PED: Study on Leishmaniasis in Children | — | Meyer Children's Hospital IRCCS | RECRUITING |
[NCT07358910](https://clinicaltrials.gov/study/NCT07358910) | Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective | — | Institut Pasteur du Cambodge | RECRUITING |
[NCT04020536](https://clinicaltrials.gov/study/NCT04020536) | Real World Study of Classic Infectious Disease | — | Huashan Hospital | RECRUITING |
[NCT06793111](https://clinicaltrials.gov/study/NCT06793111) | Visceral Leishmaniasis in Emilia-Romagna (Leishmania-2019) | — | IRCCS Azienda Ospedaliero-Universitaria di Bologna | RECRUITING |
410 publications have been identified in PubMed for leishmaniasis. Kisho has analyzed 114 by research type. Research spans Review / Meta-Analysis (61%), Basic Science / Preclinical (11%), and Epidemiology / Natural History (11%).
Research Type | Count | % of Total |
|---|---|---|
Research summaries | 69 | 61% |
Laboratory research | 12 | 11% |
Disease patterns and progression | 12 | 11% |
Patient case studies | 10 | 9% |
Other research | 4 | 4% |
Testing and diagnosis research | 4 | 4% |
Clinical study results | 2 | 2% |
New treatment approaches | 1 | 1% |
Mohammed MW (2026). [PMID: 42180139](https://pubmed.ncbi.nlm.nih.gov/42180139/). *J Parasitol Res*. [Review / Meta-Analysis]
Manathunga T (2026). [PMID: 42166495](https://pubmed.ncbi.nlm.nih.gov/42166495/). *PLoS Negl Trop Dis*. [Review / Meta-Analysis]
Aoun K (2026). [PMID: 42184356](https://pubmed.ncbi.nlm.nih.gov/42184356/). *Parasite*. [Review / Meta-Analysis]
Elmi HSA (2026). [PMID: 41505440](https://pubmed.ncbi.nlm.nih.gov/41505440/). *PLoS Negl Trop Dis*. [Other]
Zribi L (2026). [PMID: 42113845](https://pubmed.ncbi.nlm.nih.gov/42113845/). *PLoS Negl Trop Dis*. [Epidemiology / Natural History]
Dar MJ (2026). [PMID: 41653774](https://pubmed.ncbi.nlm.nih.gov/41653774/). *Redox Biol*. [Review / Meta-Analysis]
Ghosh C (2026). [PMID: 41502015](https://pubmed.ncbi.nlm.nih.gov/41502015/). *Clin Exp Dermatol*. [Review / Meta-Analysis]
Cho H (2026). [PMID: 40591906](https://pubmed.ncbi.nlm.nih.gov/40591906/). *J Infect Dis*. [Gene Therapy / Novel Therapeutics]
Freitas CS (2026). [PMID: 41964514](https://pubmed.ncbi.nlm.nih.gov/41964514/). *Cell Biochem Funct*. [Review / Meta-Analysis]
Aronson NE (2026). [PMID: 42202321](https://pubmed.ncbi.nlm.nih.gov/42202321/). *N Engl J Med*. [Review / Meta-Analysis]
AI-curated news mentioning leishmaniasis
Updated Jun 8, 2026
A recent study explores cutaneous leishmaniasis that developed from a latent dermal sinus, presenting diagnostic challenges. This research highlights the complexities in identifying this rare disease through dermoscopy.
Research reveals that eprinomectin effectively inhibits Leishmania by inducing mitochondrial dysfunction and causing cell cycle arrest. This discovery could pave the way for new therapeutic strategies against leishmaniasis.
A recent study explores local cytokine modulation and parasite visceralization in mice coinfected with Leishmania amazonensis and Schistosoma mansoni. This research provides insights into the immune response mechanisms during dual infections.