Target Product Profile for Visceral Leishmaniasis
As a prerequisite to building the strategy, the target product (treatment) profile (TPP) has been established. It is based on discussions with various visceral leishmaniasis experts, consultation with visceral leishmaniasis national control programmes in endemic countries, and specifically with leading physicians and health workers who deal with this disease on a daily basis. Our TPP is reviewed and revised annually, and shared with other investigators openly.

The priority is to develop a safe, effective, oral, short-course (11 days maximum) visceral leishmaniasis drug to replace current treatments. This will improve and simplify current case management. The aim is to develop combinations of drugs that are effective against visceral leishmaniasis in all foci of the disease.

Target Product Profile for Visceral Leishmaniasis New Chemical Entities

Optimal Target Profile Minimal Target Profile
Target Label VL and PKDL VL
Spp All species L. donovani
Distribution All areas Either India or Africa
Target Population Immunocompetent and immunosuppressed Immunocompetent
Clinical Efficacy > 95% > 90%
Resistance Active against resistant strains
Safety and Tolerability No AEs requiring monitoring 1 monitoring visit in mid/end – point
Contraindications None Pregnancy/lactation
Interactions None – Compatible for combination therapy None for malaria, TB, and HIV therapies
Formulation Oral / im depot Oral / im depot
Treatment Regimen 1/day for 10 days po/ 3 shots over 10 days bid for <10 days po; or <3 shots over 10 days
Stability 3 yrs in zone 4 Stable under conditions that can be reasonably achieved in the target region (> 2 yr)
Cost < $10 / course < $80 / course