Table 5.
Target product profile (2010)
| Acceptable | Ideal | |
|---|---|---|
| Target population | Chronic | Chronic and acute (reactivations) |
| Strains | TcI, TcII, TcV, and TcVI | All |
| Distribution | All areas | All areas |
| Adult/children | Adult | All |
| Clinical efficacy | Non-inferior to benznidazole in all endemic regions (parasitological) | Superiority to benznidazole to different phases of disease (acute and chronic) (parasitological) |
| Safety | Superiority to benznidazole | Superiority to benznidazole |
| Three CE plus two standard LE or ECG during treatment | No CE or LE or ECG needed during treatment | |
| Activity against resistant strains | Not necessary | Active against nitrofuran- and nitroimidazole-resistant Trypanosoma cruzi strains |
| Contraindications | Pregnancy/lactation | None |
| Precautions | No genotoxicity; no significant pro-arrythmic potential | No genotoxicity; no teratogenicity; no negative inotropic effect; significant proarrythmic potential |
| Interactions | No clinically significant interaction with anti-hypertensive, anti-arrythmic and anticoagulants drugs | None |
| Presentation | Oral | Oral |
| Stability | 3 years, climatic zone IV | 5 years, climatic zone IV |
| Dosing regimen | Comparable to systemic antifungal treatments | Once daily/30days |
Abbreviations: CE, clinical event; ECG, electrocardiography; LE, laboratory event.