Institute for OneWorld Health—Diseases and Programs: Visceral Leishmaniasis


	Overview	Product Pipeline	V. Leishmaniasis	Diarrheal Disease	Malaria	Chagas

Institute for OneWorld Health—Diseases and Programs: 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. VL is associated with fever, weight loss, enlargement of the spleen and liver, and anemia. If left untreated, it is nearly always fatal.

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Visceral Leishmaniasis

	Download the VL Fact Sheet (PDF)



	iOWH & VL in the News
	BBC World Film Featuring OneWorld Health Voted Year’s Best Documentary OneWorld Health Press Release 01.04.08 OneWorld Health Starts Testing Drug in India San Francisco Business Times 11.06.07 Research on New Treatment for Neglected Disease Published in The New England Journal of Medicine OneWorld Health Press Release 06.21.07 Injectable Paromomycin for Visceral Leishmaniasis in India The New England Journal of Medicine 06.21.07

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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.

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 is marketed in the U.S. as an oral formulation to treat intestinal parasites.

OneWorld Health Goals:

1. Submit an application to seek regulatory approval later this year for Paromomycin Injection in India as a once-a-day, 21-day treatment for visceral leishmaniasis. Accomplished.

2. Collaborate with a suitable partner that will manufacture this cure for an affordable price at a high standard of quality. Accomplished.

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.

OneWorld Health Results:

1. The largest phase 3 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 to treat VL.

3. Gland Pharma Limited agrees 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.

With the generous support of the Bill and Melinda Gates Foundation and other funders.

Design: Formative & A Bear Knows How