Zaynich showed a higher combined clinical cure and microbiologic response rate than meropenem in the Phase III ENHANCE-1 trial.
Drug-resistant infections are a major public health crisis. Every year in the US, more than 2.8 million antimicrobial-resistant infections occur, leading to over 35,000 deaths.
The FDA approved Zaynich (cefepime and zidebactam), a new intravenous (IV) antibiotic from Wockhardt, for adults with complicated urinary tract infections (cUTIs), including kidney infections, caused by certain Gram-negative bacteria.
A 2025 report from the WHO warned that one in six bacterial infections worldwide is now resistant to the antibiotics typically used to treat them.
cUTIs are harder to treat because they involve the kidneys, occur in patients with other health problems or carry a higher risk of spreading. They can also include infections linked to medical devices such as catheters.
Some studies on recurrent UTIs show how common resistance can become. One study found that over 92% of E. coli samples from these patients produced ESBLs, enzyme “shields” that can weaken several commonly used antibiotics.
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Zaynich is approved for infections caused by susceptible strains of E. coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae complex and Pseudomonas aeruginosa.
The approval is also a milestone for Wockhardt, the India-based pharma behind Zaynich. According to Wockhardt, Zaynich is the first New Chemical Entity (NCE) fully developed and commercialized by an Indian pharmaceutical company to receive FDA approval. An NCE is a novel active drug substance or molecule that has not previously been approved as a marketed medicine.
Zaynich uses two antibacterial components that work together in a multi-target strategy. Cefepime and zidebactam bind to different penicillin-binding proteins, or PBPs, which are essential proteins bacteria use to build and maintain their cell walls.
While cefepime attacks one set of building blocks the bacteria need to build their protective cell wall, zidebactam attacks a different set of building blocks. By hitting multiple PBPs at once, the combination is intended to create a stronger antibacterial effect than either component would have alone.
This multi-target strategy may help Zaynich remain active against some bacteria that use resistance mechanisms such as antibiotic-destroying enzymes, drug-pumping systems or changes that make it harder for antibiotics to enter the bacterial cell.
Related: GSK’s Blujepa Wins FDA Approval as First New Class of Antibiotic for UTIs
The FDA approval was supported in part by ENHANCE-1, a Phase III randomized, double-blind, multicenter trial that compared Zaynich with meropenem in hospitalized adults with cUTIs or acute kidney infection. Meropenem is a broad-spectrum carbapenem often used to treat serious infections caused by Gram-negative bacteria.
At the test-of-cure visit, 89% of patients treated with Zaynich reached a composite clinical cure and microbiologic response, compared with 68.4% of those treated with meropenem. This means patients experienced improvement or resolution of infection symptoms and cleared the bacteria being studied.
Wockhardt said Zaynich has also been made available through expanded access (early use for patients with limited treatment options) programs in several countries, including the US.
Other late-stage antibiotic programs are also targeting cUTIs. GSK and Spero Therapeutics reported positive Phase III data for tebipenem HBr, an investigational oral carbapenem antibiotic for cUTIs, including kidney infection. If approved, it could offer an oral option in a treatment area where carbapenems are typically given via IV.
More recently, Japan-based Meiji Pharma shared results from the Integral-1 Phase III trial showing that adding nacubactam, a novel beta-lactamase inhibitor, to cefepime improved treatment outcomes in adults with cUTIs or kidney infections. Another nacubactam combination, with aztreonam, also met the study’s goal. Meiji submitted a manufacturing and marketing approval application for nacubactam in Japan in December 2025.
FAQs
What does Gram-negative bacteria mean?
Gram-negative bacteria are a group of bacteria with an outer membrane that can make them harder for some antibiotics to kill. Common examples include E. coli and Pseudomonas aeruginosa.
What does “susceptible bacteria” mean?
Susceptible bacteria are bacteria that lab testing shows are likely to respond to a specific antibiotic.
Is Zaynich used for all UTIs?
No. Zaynich is approved for adults with complicated UTIs, including kidney infections, caused by specific bacteria that are shown or strongly suspected to be susceptible to the drug.
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