India, March 30 -- The recommendation clears the path for final approval by the Drugs Controller General of India.

The recommendation follows a comprehensive evaluation of the drug's clinical dossier, including nine phase-1 studies, a phase-2 study in meropenem-resistant infections, and a global phase-3 trial in complicated urinary tract infections and acute pyelonephritis, along with data from compassionate-use cases.

In the phase-3 study, zidebactam/cefepime demonstrated superiority over meropenem in combined clinical and microbiological cure, indicating strong efficacy against resistant pathogens.

Zaynich is based on a novel beta-lactam enhancer mechanism targeting MDR/XDR gram-negative bacteria, addressing a critical unmet need in ...