Drugs / WCK 5222
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | — | 2026-01-05 | “Wockhardt has successfully filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for its novel antibiotic, WCK 5222, on 5 January 2026.” wockhardt.com ↗ |
| Filed | Other | ZAYNICH | — | — | “Novel Antibiotics: ZAYNICH® (Zidebactam/Cefepime, WCK 5222) Filed for approval in India in March 2025 and planned for filing in USA by August 2025” wockhardt.com ↗ “Novel Antibiotics: ZAYNICH (Zidebactam/Cefepime, WCK 5222) Filed for approval in India and pre-NDA submission meetings completed with US FDA” wockhardt.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT03554304 | Feb → Jun 2017 | — | Wockhardt | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-01-07 | Wockhardt | Regulatory Wockhardt Files Marketing Authorisation Application for WCK 5222 with European Medicines Agency wockhardt.com ↗
Wockhardt has successfully filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for its novel antibiotic, WCK 5222, on 5 January 2026. |
| 2025-12-31 | Wockhardt | Regulatory European Medicines Agency Grants Accelerated Assessment to WCK 5222 wockhardt.com ↗
The European Medicines Agency (EMA) has informed Wockhardt that WCK 5222 (combination of Zidebactam 1g + Cefepime 2g) is eligible for Accelerated Assessment, following a pre-submission meeting with the EMA review team. |
| 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 ↗
A 15-year-old US patient with Acute Myeloid Leukemia (AML), a type of blood and bone marrow cancer, has been successfully cured of a severe, drug-resistant infection following treatment with Zaynich™ (Zidebactam/Cefepime, WCK 5222) under compassionate use. |
| 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 ↗
The overall clinical efficacy of Zaynich ® across indications was 98% at the test -of-cure (TOC), which was 7 -10 days after completion of treatment, whi le it was 100% for BSI, HABP/VABP & cIAI and 97.3% for cUTI. |
| 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 ↗
Zaynich™ turned out to be a saviour by successfully clearing a chronic bile duct infection, facilitating liver transplant leading to her discharge from the hospital. |
| 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. |
| 2017-04-03 | Wockhardt | Regulatory WOCKHARDT RECEIVES ACKNOWLEDGEMENT OF ITS BREAKTHROUGH SUPERDRUG ANTIBIOTIC WCK 5222 FOR PHASE III CLINICAL TRIAL FROM US FDA wockhardt.com ↗
In a recent meeting between Wockhardt Research team and US FDA New Drug Antibiotic Regulatory team, US FDA agreed to abridged clinical trial for Phase III for Wockhardt’s superdrug antibiotic WCK 5222. |
All press releases naming this drug 14 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | WCK 5222 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03554304 ↗ |
| Route | Intravenous | “WCK 5222 IV solution administered as either a 30- or 60-minute IV infusion)” NCT03554304 ↗ |