FDA
FDA approves Zaynich for resistant complicated UTI
Complicated urinary tract infections (cUTIs), including pyelonephritis, are increasingly driven by multidrug-resistant gram-negative pathogens, limiting available treatment options and contributing to substantial morbidity and hospitalization. On June 1, 2026, FDA approved Zaynich (cefepime and zidebactam), a new intravenous antibiotic for adults with cUTIs, including pyelonephritis, caused by susceptible gram-negative bacteria.
Zaynich combines cefepime, a fourth-generation cephalosporin, with zidebactam, a novel beta-lactam enhancer designed to improve activity against resistant gram-negative organisms. The agent was developed to address multiple resistance mechanisms, including pathogens with limited susceptibility to existing beta-lactam therapies.
The decision was supported by results from the phase 3 ENHANCE-1 trial, which enrolled 530 hospitalized adults with cUTI or acute pyelonephritis. At the test-of-cure assessment, Zaynich achieved a combined clinical cure and microbiologic response rate of 89.0% compared with 68.4% for meropenem, representing a treatment difference of 20.6 percentage points (95% confidence interval, 12.3-29.5). The regimen was generally well tolerated.
New treatment options are needed as antimicrobial resistance continues to erode the effectiveness of existing therapies. More than 2.8 million antimicrobial-resistant infections occur annually in the United States, and resistant gram-negative organisms remain a major challenge in hospitalized patients with serious UTIs.
“Multidrug-resistant bacterial infections are a substantial burden for patients and the healthcare system, as patients with these infections typically require longer, more intensive care, and are at increased risk of life-threatening complications,” said Keith Kaye, MD, MPH, professor of medicine and division chief of Infectious Diseases at Rutgers Robert Wood Johnson Medical School. “There is an ongoing need for new antibiotics to combat these drug-resistant pathogens, and we are pleased that this approval means patients will soon have an exciting unique option that is urgently needed in the US and worldwide.”
Source: Wockhardt. (2026, June 1). Press release. Wockhardt receives U.S. FDA approval for Zaynich (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adult patients with complicated urinary tract infection including pyelonephritis