Drugs / Cefepime
last change Jun 2026 re-read 8 days ago

Cefepime

Small molecule

Developed for
neutropenia · acute pyelonephritis · urinary tract infection · bacterial pneumonia · bacterial infectious disease · aspiration pneumonia · aspiration pneumonitis · endocarditis
+11 more · infectious disease · infectious disease with sepsis · infectious peritonitis · nosocomial infection · respiratory tract infectious disorder · cystic fibrosis · escherichia coli infection · gram-negative bacterial infections · osteomyelitis · pneumonia · skin infection
Investigated by
Wockhardt · Allecra · Venatorx Pharmaceuticals, Inc. · Clinartis · Medpace, Inc. · Janssen Research & Development, LLC
+29 more · Meiji Seika Pharma Co., Ltd. · National Cancer Institute (NCI) · National Institute of Allergy and Infectious Diseases (NIAID) · National Institutes of Health (NIH) · Associazione Oncologica Milanese AmoLaVita ONLUS · Bellvitge Biomedical Research Institute · Beni-Suef University · Biomedical Advanced Research and Development Authority · Chulalongkorn University · Eric Solutions LLC · Hospital Universitari de Bellvitge · Hospital de Clinicas de Porto Alegre · Indonesia University · Instituto de Salud Carlos III · Jonsson Comprehensive Cancer Center · Linical Co., Ltd. · Massachusetts General Hospital · Memorial Sloan Kettering Cancer Center · Murdoch Childrens Research Institute · Onze Lieve Vrouw Hospital · Ospedale San Carlo Borromeo · Quintiles, Inc. · Semmelweis University · Siam Pharmaceutical Co Ltd · The Kidney Foundation of Thailand · UConn Health · University Ghent · Wake Forest University Health Sciences · West Virginia University

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Exblifep — 2024-03-21 europa.eu ↗
Label expansions (3) US (FDA) MAXIPIME — 1997-05-16 – 2003-03-17 fda.gov ↗
Approved US (FDA) MAXIPIME — 1996-01-18 fda.gov ↗
Filed Other ZAYNICH — —

“Novel Antibiotics: ZAYNICH® (Zidebactam/Cefepime, WCK 5222) Filed for approval in India and pre-NDA submission meetings completed with US FDA” wockhardt.com ↗

“Novel Antibiotics: ZAYNICH® (Zidebactam/Cefepime, WCK 5222) Filed for approval in India in March 2025” wockhardt.com ↗

Filed US (FDA) — — —

“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) — — —

“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 ↗

Trials 39

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 115 trials
Phase 1 NCT06806995 Jan → Feb 2025 pseudohypoparathyroidism type 1A Wockhardt Completed No outcome recorded
Phase 1 NCT04816968 Sep 2021 → Sep 2023 bacterial infectious disease Ospedale San Carlo Borromeo Unknown No outcome recorded
Phase 1 NCT04951505 Jun → Sep 2021 — Venatorx Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT03870490 Mar → Apr 2019 — Venatorx Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT03690362 Apr → Nov 2018 — Venatorx Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT03622008 Mar → May 2018 flucloxacilline toxicity Wockhardt Completed No outcome recorded
Phase 1 NCT03332732 Oct → Dec 2017 bacterial infectious disease Venatorx Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT03680352 Sep 2017 → Dec 2018 — Allecra Completed No outcome recorded
Phase 1 NCT03680378 Jul 2017 → Apr 2019 — Allecra Completed No outcome recorded
Phase 1 NCT03630094 Mar → Jun 2017 pseudohypoparathyroidism type 1A Wockhardt Completed No outcome recorded
Phase 24 trials
Phase 2 NCT06406114 May 2025 → Jul 2028 expected anaphylaxis, drug allergy, drug pseudoallergy Massachusetts General Hospital Recruiting No outcome recorded
Phase 2 NCT05826990 Sep 2023 → Sep 2025 urinary tract infection Allecra Unknown No outcome recorded
Phase 2 NCT03680612 Sep 2017 → Feb 2018 urinary tract infection Allecra Completed No outcome recorded
Phase 2 NCT03078010 Feb 2017 → Feb 2027 expected neutropenia Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 312 trials · 4 met primary
Phase 3 NCT06168734 Jun 2025 → Jun 2027 bacterial pneumonia Venatorx Pharmaceuticals, Inc. Withdrawn No outcome recorded
Phase 3 NCT03630081 Jan 2024 → Jan 2026 acute pyelonephritis Wockhardt Unknown No outcome recorded
Phase 3 NCT05905055 Sep 2023 → Sep 2025 acute pyelonephritis, bacterial pneumonia Meiji Seika Pharma Co., Ltd. Completed No outcome recorded
Phase 3 NCT05887908 May 2023 → Nov 2024 acute pyelonephritis Meiji Seika Pharma Co., Ltd. Completed Met primary
Phase 3 NCT06048692 Jan → Sep 2023 — Beni-Suef University Unknown No outcome recorded
Phase 3 NCT04979806 Aug 2022 → Nov 2024 acute pyelonephritis Wockhardt Completed Met primary
Phase 3 NCT03840148 Aug 2019 → Dec 2021 acute pyelonephritis Venatorx Pharmaceuticals, Inc. Completed Met primary
Phase 3 NCT03687255 Sep 2018 → Jan 2020 urinary tract infection Allecra Completed Met primary
Phase 3 NCT02568800 Oct 2015 → Mar 2016 respiratory tract infectious disorder, urinary tract infection Hospital de Clinicas de Porto Alegre Unknown No outcome recorded
Phase 3 NCT01110421 Dec 2010 → Mar 2012 bacterial pneumonia, nosocomial infection Janssen Research & Development, LLC Terminated No outcome recorded Stop: Business
Phase 47 trials · 1 met primary
Phase 4 NCT07484633 Apr 2026 → Apr 2028 expected infectious disease with sepsis Semmelweis University Not yet recruiting No outcome recorded
Phase 4 NCT05156437 Mar 2022 → Oct 2024 endocarditis West Virginia University Terminated No outcome recorded
Phase 4 NCT05079620 Nov 2021 → Apr 2024 aspiration pneumonia, aspiration pneumonitis UConn Health Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT04948463 Nov 2021 → Dec 2025 neutropenia Murdoch Childrens Research Institute Completed No outcome recorded
Phase 4 NCT04233996 Jun 2019 → Dec 2021 neutropenia Hospital Universitari de Bellvitge Unknown No outcome recorded
Phase 4 NCT04187755 Mar → Jul 2019 childhood malignant neoplasm, leukemia, neutropenia Indonesia University Completed No outcome recorded
Phase 4 NCT02872038 Aug 2015 → Nov 2016 infectious peritonitis Chulalongkorn University Completed Met primary
Phase not applicable1 trial
— NCT02680600 Mar 2014 → Jul 2015 — Onze Lieve Vrouw Hospital Completed No outcome recorded
Comparator or background therapy30 trials
Phase 0 NCT02099240 Comparator Mar 2014 → Nov 2018 osteomyelitis University of Louisville Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT05588531 Comparator Dec 2021 → Apr 2022 — Nanjing Yoko Biomedical Co., Ltd. Completed No outcome recorded
Phase 1 NCT02707107 Comparator Mar → Apr 2016 gram-negative bacterial infections Wockhardt Completed No outcome recorded
Phase 2 NCT07318584 Comparator Mar 2026 → Feb 2028 expected escherichia coli discitis Oregon Health and Science University Not yet recruiting No outcome recorded
Phase 2 NCT04983901 Comparator Sep 2021 → Oct 2023 cancer, hematopoietic and lymphoid cell neoplasm M.D. Anderson Cancer Center Completed No outcome recorded

News releases announcing trial results or a regulatory action · 13

DateIssuerRelease
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.
2024-09-19 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 17 releases

DateIssuerRelease

Evidence & citations 26 cited values

Every value below carries the sentence it was read from. 72 sources stand behind the page.

FieldValueCited text
Known as Cefepime “Beta lactam antibiotics for non-ESBL E. coli infections include preferred ceftriaxone or alternative cephalosporins (cefepime, ceftazidime), penicillins...” NCT07318584 ↗
65

“Calcium sulfate beads will be loaded with best available antibiotics based on surgeon/infectious disease specialist determination from the following options (vancomycin,...” NCT07072923 ↗

“This therapy is usually one of the following intravenous medications: (i) piperacillin/tazobactam (Zosyn), (ii) cefepime, (iii) metronidazole, (iv) aztreonam, (v) vancomycin,...” NCT02168816 ↗

“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 ↗

“Drug stop within 24 hours after randomization:Piperacillin-tazobactam, amikacin, meropenem, cefepime, ceftazidime, vancomycin, teicoplanin, ciprofloxacin, levofloxacine and...” NCT07590648 ↗

“Safety and Pharmacokinetics of Taniborbactam (VNRX-5133) with Cefepime in Subjects with Various Degrees of Renal Impairment.” PMID 35920662 ↗ Aug 2022

“Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin” NCT03409679 ↗

“FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days” NCT03622008 ↗

“IV antibiotics (cefepime \& vancomycin) are started in pre-op approximately 1 hour prior to incision” NCT04042233 ↗

“WCK 5222 is a novel β-lactam-β-lactam-enhancer combination of cefepime (FEP) and zidebactam (ZID).” PMID 30397067 ↗ Dec 2018

“Includes antibiotics such as ceftriaxone, cefepime, piperacillin-tazobactam, and meropenem.” NCT06080698 ↗

Show 55 more sources

Known as BMY-28142 ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as BMY-28142 2HCL.H20 ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as BMY-28142 2HCL.H2O ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as BMY-28142 DIHYDROCHLORIDE MONOHYDRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as CEF “Pregnant women (n=100) received IV cefepime (CEF) (maxipime®1000mg) 30 minutes before cesarean delivery (CD) and 12 hours after CD” NCT06048692 ↗
Known as Cefepima ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as Cefepime (as hydrochloride) ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as Cefepime dihydrochloride hydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as Cefepime dihydrochloride monohydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as Cefepime hcl ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as cefepime hydrochloride “cefepime hydrochloride 1gm IM q24h” NCT00358202 ↗
2

“cefepime (cefepime hydrochloride)” NCT01484015 ↗

NCT05588531 ↗

Known as Cefepime hydrochloride (arginine formulation) ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as Cefepime hydrochloride component of exblifep ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as Cefepime hydrochloride monohydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as CFP “cefepime (CFP): 30-50 mg/kg q8h or q12h (\>1 month: 30 mg/kg every 8-12 hours, 2 months-17 years (bodyweight up to 41 kg): 50 mg/kg every 8-12 hours (max. 2 g per dose;...” NCT07484633 ↗
Known as CFPM “We conducted a non-inferiority, open-label, randomized controlled trial comparing intravenous CPFX and cefepime (CFPM) for FN patients with hematological malignancies.” PMID 23317527 ↗ Jan 2013
Known as Exblifep ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as FEP “WCK 4282 is a combination product of cefepime (FEP) and tazobactam (TAZ) in a 1:1 ratio currently under development for the treatment of multidrug-resistant Gram-negative...” PMID 31332068 ↗ Sep 2019
1

“WCK 5222 is a novel β-lactam-β-lactam-enhancer combination of cefepime (FEP) and zidebactam (ZID).” PMID 30397067 ↗ Dec 2018

Known as J01DE01 ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as Maxipime “Maxipime®, a powder for the preparation of a solution for intravenous and intramuscular administration of 1.0 g” NCT03638830 ↗
Known as NSC-760051 ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as Renapime ChEMBL registry synonym — accepted as the source's own label CHEMBL186 ↗
Known as VNRX-5022 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03332732 ↗
Modality Small molecule “Cefepime is a fourth generation cephalosporin with broad spectrum activity against Gram-negative bacteria” NCT02680600 ↗