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A severe form of leishmaniasis characterized by irregular bouts of fever, substantial weight loss, swelling of the spleen and liver, and anemia (which may be serious). If left untreated it may lead to death. Two species of Leishmania are known to give rise to the visceral form of the disease. The species commonly found in East Africa and the Indian subcontinent is L. donovani and the species found in Europe, North Africa, and Latin America is L. infantum, also known as L. chagasi.
Biomarker and diagnostic research for visceral leishmaniasis has been reported in the published literature.
1 FDA-approved treatment is available for visceral leishmaniasis, including AMPHOTERICIN B (AMBISOME, approved 1997). An additional 3 compounds hold orphan drug designation.
Brand Name | Generic Name | Mechanism | Approved | Market Status |
|---|---|---|---|---|
10 clinical trials registered, 5 recruiting. Interventions under study include other interventions, drug therapy, and medical devices. Pipeline includes 1 PHASE2, 2 NA. Research is primarily sponsored by academic and government institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT04020536](https://clinicaltrials.gov/study/NCT04020536) |
Data assembled from 4 of 12 sources · Last updated Sep 20, 2026, 1:00 AM UTC
AMBISOME |
AMPHOTERICIN B |
— |
1997 |
Available |
The following drugs have received orphan drug designation from the FDA for visceral leishmaniasis. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor | Designated | Exclusivity End | Designation Status |
|---|---|---|---|---|---|
corifungin | corifungin | Sandler Center for Drug Discovery | 2011 | — | Designated |
aminosidine | aminosidine | The Institute for One World Health | 2005 | — | Designated |
Allopurinol riboside | Allopurinol riboside | Burroughs Wellcome Company | 1985 | — | Withdrawn |
Gene therapy approaches for visceral leishmaniasis have been reported in the published literature.
10 trials found
Real World Study of Classic Infectious Disease
— |
Huashan Hospital |
RECRUITING |
[NCT05602610](https://clinicaltrials.gov/study/NCT05602610) | Clinical Prognostic Score to Predict Relapse in VL | — | Institute of Tropical Medicine, Belgium | RECRUITING |
[NCT07487350](https://clinicaltrials.gov/study/NCT07487350) | Recurrent Visceral Leishmaniasis in HIV Co-Infection | — | Institute of Tropical Medicine, Belgium | RECRUITING |
[NCT00344188](https://clinicaltrials.gov/study/NCT00344188) | Diagnosis and Treatment of Leishmania Infections | — | National Institute of Allergy and Infectious Diseases (NIAID) | RECRUITING |
[NCT07783243](https://clinicaltrials.gov/study/NCT07783243) | Ex Vivo Immunogenicity Screening of Vaccine Candidate Antigen Combinations in Ethiopian Patients With Leishmaniasis | — | Institute of Tropical Medicine, Belgium | RECRUITING |
338 publications have been identified in PubMed for visceral leishmaniasis. Research spans Epidemiology / Natural History (26%), Review / Meta-Analysis (24%), and Basic Science / Preclinical (18%).
Research Type | Count | % of Total |
|---|---|---|
Disease patterns and progression | 88 | 26% |
Research summaries | 82 | 24% |
Laboratory research | 61 | 18% |
Patient case studies | 38 | 11% |
Testing and diagnosis research | 26 | 8% |
New treatment approaches | 21 | 6% |
Other research | 11 | 3% |
Clinical study results | 11 | 3% |
Ghosh C (2026). [PMID: 41502015](https://pubmed.ncbi.nlm.nih.gov/41502015/). *Clin Exp Dermatol*. [Review / Meta-Analysis]
Konhar R (2026). [PMID: 41849302](https://pubmed.ncbi.nlm.nih.gov/41849302/). *PLoS Negl Trop Dis*. [Basic Science / Preclinical]
Tian M (2026). [PMID: 41886785](https://pubmed.ncbi.nlm.nih.gov/41886785/). *Am J Trop Med Hyg*. [Case Report / Case Series]
Dambrós BP (2026). [PMID: 41779509](https://pubmed.ncbi.nlm.nih.gov/41779509/). *Rev Soc Bras Med Trop*. [Review / Meta-Analysis]
Rishav (2026). [PMID: 41768921](https://pubmed.ncbi.nlm.nih.gov/41768921/). *J Parasit Dis*. [Review / Meta-Analysis]
Yazısız H (2026). [PMID: 41948960](https://pubmed.ncbi.nlm.nih.gov/41948960/). *Turkiye Parazitol Derg*. [Diagnostic / Biomarker]
Moodley M (2026). [PMID: 42127151](https://pubmed.ncbi.nlm.nih.gov/42127151/). *PLoS Negl Trop Dis*. [Clinical Trial Publication]
Mukherjee S (2026). [PMID: 41847196](https://pubmed.ncbi.nlm.nih.gov/41847196/). *Front Microbiol*. [Review / Meta-Analysis]
Partovi Moghaddam S (2026). [PMID: 42057918](https://pubmed.ncbi.nlm.nih.gov/42057918/). *Curr Res Parasitol Vector Borne Dis*. [Review / Meta-Analysis]
Li S (2026). [PMID: 41579979](https://pubmed.ncbi.nlm.nih.gov/41579979/). *Microbial pathogenesis*. [Review / Meta-Analysis]
AI-curated news mentioning visceral leishmaniasis
Updated Jul 28, 2026
A case report highlights the diagnostic challenges of visceral leishmaniasis-associated hemophagocytic lymphohistiocytosis in a patient with Crohn's disease undergoing anti-TNFα therapy. This study underscores the complexities of diagnosing rare diseases in patients with existing conditions.
A recent study reports two cases of visceral leishmaniasis potentially linked to autoimmune disease, highlighting the complex interplay between infectious and autoimmune conditions. This research may inform future diagnostic and treatment approaches for affected patients.
A case study highlights visceral leishmaniasis as a rare complication in a multiple sclerosis patient undergoing treatment with fingolimod, which induces lymphopenia. This finding underscores the need for vigilance in monitoring opportunistic infections in patients receiving immunosuppressive therapies.