Drugs / Zidebactam
Zidebactam
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed gram-negative bacterial infections 2 milestones | |||||
| Filed | US (FDA) | Zidebactam/Cefepime | gram-negative bacterial infections | — | “A New Drug Application (NDA) in the United States and a Marketing Authorisation Application (MAA) in the European Union for Zidebactam/Cefepime have already been submitted” wockhardt.com ↗ |
| Filed | EU (EMA) | Zidebactam/Cefepime | gram-negative bacterial infections | — | “A New Drug Application (NDA) in the United States and a Marketing Authorisation Application (MAA) in the European Union for Zidebactam/Cefepime have already been submitted” wockhardt.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | ZAYNICH | — | 2026-05-29 | fda.gov ↗ |
| Filed | Other | ZAYNICH | — | — | “ZAYNICH® (Zidebactam/Cefepime, WCK 5222) Filed for approval in India in March 2025” wockhardt.com ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT06806995 | Jan → Feb 2025 | pseudohypoparathyroidism type 1A | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT05645757 | Apr → Nov 2023 | bacterial infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT07247942 | Dec 2017 → Jan 2018 | — | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT03630094 | Mar → Jun 2017 | pseudohypoparathyroidism type 1A | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT02942810 | Oct 2016 → Apr 2017 | impaired renal function disease | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT02674347 | Feb → Apr 2016 | — | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT02532140 | Aug → Nov 2015 | — | Wockhardt | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07840105 | Sep 2026 → Sep 2027 expected | acute pyelonephritis | Wockhardt | Not yet recruiting | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT04979806 | Aug 2022 → Nov 2024 | acute pyelonephritis | Wockhardt | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT02707107 Comparator | Mar → Apr 2016 | gram-negative bacterial infections | Wockhardt | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-05-30 | Wockhardt | Regulatory 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 wockhardt.com ↗
Wockhardt today announced that the U.S. Food and Drug Administration (FDA) has approved Z AYNICH™ (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. |
| 2026-05-28 | Wockhardt | Regulatory Indian drug regulator grants marketing authorization to Wockhardt’s breakthrough antibiotic, ZAYNICH® (Zidebactam/ Cefepime), for treatment of complicated urinary tract infections including pyelonephritis with concurrent Gram – negative bacteremia wockhardt.com ↗
Wockhardt Ltd. today announced that the Central Drugs Standard Control Organisation (CDSCO) has granted authorization for the import and marketing of its indigenously discovered and developed, first-in-class breakthrough antibiotic, Zaynich® (Zidebactam / Cefepime) in India. |
| 2026-03-30 | Wockhardt | Regulatory Wockhardt’s Zaynich ® (Zidebactam/Cefepime) Receives Favourable Recommendation from CDSCO’s Subject Expert Committee for Treatment of Gram – Negative Infections wockhardt.com ↗
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO), has granted a favourable recommendation for marketing permission of Wockhardt’s novel antibiotic, Zaynich ® (Zidebactam/Cefepime), for the treatment of Gram -negative infections. |
| 2025-10-01 | Wockhardt | Regulatory Wockhardt Submits New Drug Application to U.S. FDA for Zidebactam – Cefepime (WCK 5222) for Treatment of Serious Gram – Negative Infections wockhardt.com ↗
Wockhardt today announced the submission of New Drug Application ( NDA) to the U.S. Food and Drug Administration (US FDA) for its novel antibacterial agent Zidebactam-Cefepime injection (WCK 5222, ZAYNICH ). |
| 2025-07-28 | Wockhardt | Results Leading U.K. Medical Journal publishes a Complex Case of Severe Pan – drug Resistant Infection in U.S. Liver Transplant Patient Successfully Treated with Zaynich ® (Zidebactam/Cefepime, WCK 5222) wockhardt.com ↗
The publication details the successful use of Zaynich ®, a combination of Zidebactam and Cefepime, in treating a critically ill U.S. liver transplant patient suffering from a pan-drug resistant infection—an infection resistant to all available antibiotics in the United States. |
| 2025-04-01 | Wockhardt | Results Paediatric US Cancer Patient with Recalcitrant Blood and Liver Infection Successfully Treated with Zaynich™ (Zidebactam/Cefepime, WCK 5222) wockhardt.com ↗
Following the approval, the patient was treated with Zaynich™ for 41 days, resulting in the successful resolution of the infection and a stabilization of the patient's clinical condition. |
| 2025-01-31 | Wockhardt | Results Wockhardt’s Zaynich® (Zidebactam/Cefepime, WCK 5222) achieves highest – ever efficacy meeting superiority in a global, pivotal, registration – enabling Phase III study in complicated urinary tract infection (cUTI) achieving 96.8% clinical cure rate wockhardt.com ↗
With respect to clinical cure, Zaynich ® achieved 96.8% efficacy. |
| 2025-01-13 | Wockhardt | Results Zaynich® (Zidebactam/Cefepime, WCK 5222) achieves over 97% Efficacy in Clinical Study for serious infections caused by Meropenem – Resistant Gram – Negative Pathogens wockhardt.com ↗ |
| 2024-12-16 | Wockhardt | Results Zaynich™ (Zidebactam/Cefepime, WCK 5222) enables US cancer patient undergo successful liver transplant and resume chemotherapy by eradicating dual extreme – drug resistant Gram negative pathogens wockhardt.com ↗
15 days of treat ment with Zaynich ™ helped control infectious processes and cleared the way for the transplant in this patient. |
| 2024-10-07 | Wockhardt | Regulatory Wockhardt’s another breakthrough antibiotic: once a – day β – lactam enhancer, WCK 6777 with unique out – patient treatment advantage granted Fast Track designation by US FDA and successfully completes Phase I study conducted by National Institutes of Health, US wockhardt.com ↗
Additionally, recognizing its potential to meet significant unmet medical needs, the US FDA has recently granted Fast Track designation to WCK 6777 for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI). |
| 2024-09-19 | Wockhardt | Results Wockhardt’s Investigational Drug, Zaynich™ (Zidebactam/Cefepime) cures complex case of meningitis caused by pan – drug resistant super – bug under compassionate use wockhardt.com ↗
This represents the first case of nosocomial meningitis caused by multidrug -resistant Pseudomonas successfully treated with Zidebactam/Cefepime, underscoring its potential as a valuable therapeutic option. |
| 2024-06-28 | Wockhardt | Results Successful Use of Investigational Antibiotic, Zaynich (Zidebactam/Cefepime WCK 5222) to Treat a Cancer Patient in US with Chronic Bilateral Thigh Infection Caused by an Extreme Drug Resistant Pseudomonas wockhardt.com ↗
This case marks the first instance in the US where Zaynich (Zidebactam/Cefepime- WCK 5222) has been employed to combat a complex infection caused by extreme-drug resistant Pseudomonas. |
| 2024-03-11 | Wockhardt | Results A leading European Journal reports Renal Transplant Patient’s unique Clinical Case of Successful use of Zidebactam/Cefepime (WCK 5222, Zaynich TM ) to Treat Skull Bone Infection & Pneumonia caused by Extreme – drug Resistant Pseudomonas wockhardt.com ↗
As all the available antibiotics failed to treat the infection, the patient was successfully treated with Zidebactam/Cefepi me (WCK 5222, Zaynich TM) under compassionate grounds following due approval from Drugs Controller General of India. |
All press releases naming this drug 14 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zidebactam | “A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination Utilizing a 3-Period,...” NCT06806995 ↗8“WCK 5222 is a novel β-lactam-β-lactam-enhancer combination of cefepime (FEP) and zidebactam (ZID).” PMID 30397067 ↗ Dec 2018 “3 g of zidebactam (1 g q8h) and 6 g of cefepime (2 g q8h) or 6” NCT02707107 ↗ “WCK 5222 (Cefepime and Zidebactam)” NCT03630094 ↗ |
| Known as | WCK 5107 | “Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion.” NCT07247942 ↗ |
| Known as | ZID | “WCK 5222 is a novel β-lactam-β-lactam-enhancer combination of cefepime (FEP) and zidebactam (ZID).” PMID 30397067 ↗ Dec 2018 |
| Action | Inhibit | “A betaß-lactamase inhibitor and betaß-lactam enhancer from the diazabicyclooctane (DBO) class” NCT05645757 ↗ |
| Modality | Small molecule | “A betaß-lactamase inhibitor and betaß-lactam enhancer from the diazabicyclooctane (DBO) class” NCT05645757 ↗ |
| Route | Intravenous | “single intravenous doses of WCK 5107 alone and in combination with cefepime” NCT02532140 ↗ |