While most novel antibacterial development is focused on complicated infections treated in the hospital setting, Iterum Therapeutics PLC and Paratek Pharmaceuticals Inc. are using the US FDA’s Qualified Infectious Disease Product (QIDP) incentive program to advance what could be the first new oral agents in 20 years for one of the most common infections seen in the community setting, uncomplicated urinary tract infection (uUTI).
Iterum’s sulopenem became the first product to enter Phase III with a QIDP designation for uUTI when the SURE-1 trial kicked off in August