Product Development Award
Therapeutics
2023
11 / 01 / 2023
09 / 30 / 2026
36
Phase 3
Neonatal sepsis
World
GARDP Foundation / Switzerland
Jeil Pharmaceutical / Republic of Korea
4,000,000,000
This project uses an innovative approach to identify and evaluate the safety and effectiveness of novel combinations of three existing antibiotics (flomoxef, fosfomycin, and amikacin), which are licensed for neonates. The use of these drugs will be compared against existing recommended and commonly used regimens in their ability to reduce mortality due to neonatal sepsis. This grant includes cost-effective Active Pharmaceutical Ingredient manufacturing processes and strengthening manufacturing capacity for flomoxef. Additionally, the project aims to advance access to flomoxef, including WHO prequalification and direct national registration routes. This project not only addresses the critical issue of AMR but also represents a significant advancement in the fight against neonatal sepsis by providing improved and new treatment recommendations across diverse settings.