Visceral Leishmaniasis

(also known as kala-azar) is a deadly disease transmitted via the bite of an infected sand fly. Visceral leishmaniasis (VL) is the most dangerous of the three manifestations of disease caused by the Leishmania parasite because the parasite migrates into the vital organs. VL is associated with fever, weight loss, enlargement of the spleen and liver, and anemia. If left untreated, VL is nearly always fatal.

The Global Burden of Visceral Leishmaniasis

Approximately 500,000 new cases of visceral leishmaniasis arise annually worldwide. Over 90% of visceral leishmaniasis cases occur in India, Bangladesh, Sudan, Brazil, and Nepal.

View Details About Current Treatments

OneWorld Health's Response

OneWorld Health is developing the antibiotic Paromomycin Intramuscular (IM) Injection as a new treatment for visceral leishmaniasis. Paromomycin IM Injection is an off-patent aminoglycoside antibiotic that has been marketed in the U.S. as an oral formulation to treat intestinal parasites.

Read More About Our VL Drug Program

OneWorld Health Goals

1. Conduct post marketing surveillance safety study in India.
2. Conduct post-approval program in India with the goal of developing a scalable, transferable, access model for treatment of outpatients in increasingly resource constrained settings.
3. Establish collaborations with government agencies and other global health organizations to distribute this drug to all patients who need treatment, conduct clinical trials in other parts of the affected world (e.g., Bangladesh, Nepal, Sudan, Brazil), and seek regulatory approval in these and other affected countries.

One World Health Results

1. The largest phase III clinical trial ever performed for VL concluded in November 2004. OneWorld Health, in collaboration with the Special Programme for Research and Training in Tropical Diseases of the World Health Organization (WHO/TDR) treated 666 VL patients in India.
2. In early 2005, OneWorld Health received Orphan Drug Designation from the two leading regulatory agencies in the world — the FDA and the European Agency for the Evaluation of Medicinal Products (EMEA) — for Paromomycin IM Injection to treat VL.
3. Gland Pharma Limited agreed to manufacture Paromomycin IM Injection.
4. On August 31, 2006 the Drug Controller General of India (DCGI) approved Paromomycin IM Injection for the treatment of visceral leishmaniasis.
5. In May 2007 Paromomycin IM Injection was included on the World Health Organization's Model List of Essential Medicines.