Target Product Profile

AcceptableIdeal
Target labelChronic Indeterminate CDChronic Indeterminate + Reactivations (Immunocompromised)
Spp.TcI+TcIITcI+TcII
DistributionAll areasAll areas
Target populationImmunocompetentImmunocompetent + immunocompromised
Adult/childrenAdultAll
Clinical efficacySuperiority over benznidazole in all endemic regions (parasitological)70% (parasitological and serological) > 95% cure for reactivated patients (parasitological and serological)
ResistanceActive against nitrofuran- and nitroimidazole-resistant T. cruzi strainsActive against nitrofuran- and nitroimidazole-resistant T. cruzi strains
SafetySuperiority to benznidazole 3 Clinical Evaluation plus 2 standard Laboratory Evaluation during treatmentSuperiority to benznidazole No Clinical Evaluation or Laboratory Evaluation needed during treatment
ContraindicationsPregnancy/lactationNone
PrecautionsNo genotoxicity; No prolongation of QTc intervalNo genotoxicity; No teratogenicity; No negative inotropic effect; No prolongation of QTc interval
InteractionsNo clinically significant interaction with anti-hypertensive, anti-arrythmic and anticoagulants drugsNone
PresentationOralOral
Stability3 years, climatic zone IV5 years, climatic zone IV
Dosing regimeComparable to systemic antifungal treatmentsb.i.d./60 days
Mar/22/10
Film and Debate Click here for more... (Buenos Aires, Argentina)
Apr/19/10
Geneva Health Forum Click here for ... (Geneva, Switzerland)