# Zaynich結合Zidebactam與Cefepime，已獲准用於治療複雜性尿路感染。

*biotech · news · 2026-05-30 · Moneycontrol*

## Key points

- FDA批准Wockhardt的Zaynich用於成人複雜性尿路感染。
- Zaynich對革蘭氏陰性菌血症有效，包括廣泛耐藥（XDR）病原體。
- Wockhardt亦獲印度CDSCO批准進口並在國內銷售Zaynich。
- 關鍵的ENHANCE-1三期臨床試驗顯示Zaynich在複雜性尿路感染患者中對比美羅培南的療效。
- 臨床與實驗室標準協會（CLSI）為Cefepime/Zidebactam指定了64 mg/L的調查性敏感性斷點。

The US Food and Drug Administration (FDA), on Saturday, approved Wockhardt’s antibiotic Zaynich for the treatment of complicated urinary tract infections (cUTIs) in adults caused by designated susceptible microorganisms, the company said on Thursday. Zaynich, a combination of Zidebactam and Cefepime, has been cleared for the treatment of complicated urinary tract infections, including kidney infections known as pyelonephritis, in adult patients. The approval also covers cases accompanied by Gram-negative bacteremia, a serious bloodstream infection caused by bacteria. Earlier on Friday, Wockhardt Ltd said it has also received approval from India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), for the import and marketing of the indigenously discovered and developed antibiotic in the country. “The approval is for the treatment of adult patients (18 years and above) with complicated urinary tract infections (cUTI), including pyelonephritis, as well as cases with concurrent Gram-negative bacteremia,” the company said in a regulatory filing. According to Wockhardt, the approvals were backed by data from the pivotal ENHANCE-1 study, a multinational, randomised, double-blind Phase 3 clinical trial that evaluated the efficacy and safety of Zaynich against meropenem in patients suffering from cUTI, including pyelonephritis. The company said the drug demonstrated efficacy against difficult-to-treat Gram-negative bacterial infections, including extensively drug-resistant (XDR) pathogens. “In recognition of its broad-spectrum potential, the Clinical and Laboratory Standards Institute has assigned Cefepime/Zidebactam an investigational susceptible breakpoint of 64 mg/L,” Wockhardt said, adding that the designation supports the drug’s potential use against clinically significant XDR Gram-negative pathogens in critically ill patients. Zaynich combines Cefepime, a fourth-generation cephalosporin antibiotic, with Zidebactam, a novel beta-lactam enhancer developed by Wockhardt.

**Companies:** Wockhardt
**Countries:** United States, India

[Read the full story on Moneycontrol](https://www.moneycontrol.com/news/business/us-fda-approves-wockhardt-s-zaynich-for-treatment-of-complicated-uti-in-adults-13936178.html)

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