QIDP Program Heads Into Uncomplicated Territory: Iterum, Paratek Eye uUTI Indications

Iterum’ssulopenem is first QIDP candidate to enter Phase III for uncomplicated urinary tract infection; Paratek’sNuzyra could be next.

X-ray image of bladder, Showing cystitis or lower urinary tract infection

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

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Review Pathways

More from Pathways & Standards