Drugs / Cefepime
Cefepime
also known as
cefepime hydrochloride · FEP · BMY-28142 · BMY-28142 2HCL.H20 · BMY-28142 2HCL.H2O · BMY-28142 DIHYDROCHLORIDE MONOHYDRATE · CEF · Cefepima · +15 more
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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 ↗ |
Trials 39 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 1 | NCT02942810 | Oct 2016 → Apr 2017 | impaired renal function disease | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT02709382 | Mar → Aug 2016 | impaired renal function disease | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT02532140 | Aug → Nov 2015 | — | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT03685084 | Oct 2013 → Jan 2014 | — | Allecra | Completed | No outcome recorded |
| Phase 1 | NCT01484015 | Feb 2011 → Jun 2012 | Burkitt lymphoma, Hodgkins lymphoma, MALT lymphoma, acute myeloid leukemia +25 | Wake Forest University Health Sciences | 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 | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT06048692 | Jan → Sep 2023 | — | Beni-Suef University | Unknown | No outcome recorded |
| Phase 3 | NCT04979806 | Aug 2022 → Nov 2024 | acute pyelonephritis | Wockhardt | Completed | No outcome recorded |
| Phase 3 | NCT03840148 | Aug 2019 → Dec 2021 | acute pyelonephritis | Venatorx Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03687255 | Sep 2018 → Jan 2020 | urinary tract infection | Allecra | Completed | No outcome recorded |
| 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 |
| Phase 3 | NCT01110408 | Dec 2010 → Jun 2013 | urinary tract infection | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 3 | NCT00020865 | Sep 2001 → ? | cancer of unknown primary site, infectious disease, leukemia, lymphoma +1 | Jonsson Comprehensive Cancer Center | Unknown | No outcome recorded |
| Phase 47 trials | ||||||
| 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 |
| 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 | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02680600 | Mar 2014 → Jul 2015 | — | Onze Lieve Vrouw Hospital | Completed | No outcome recorded |
Also used as a comparator or background therapy in 30 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 12 trials | ||||||
| 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 27 trials | ||||||
| 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 |
| Phase 2 | NCT03638830 Background | Oct 2018 → Nov 2022 | Pseudomonas aeruginosa infectious disease, bacterial urinary tract infection | Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation | Completed | No outcome recorded |
| Phase 2 | NCT03485950 Comparator | May 2018 → May 2021 | infectious disease | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02732327 Comparator | May → Jun 2016 | neoplasm, neutropenia | Forest Laboratories | Terminated | No outcome recorded |
| Phase 2 | NCT02497781 Comparator | Sep 2015 → Sep 2017 | urinary tract infection | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02168816 Comparator | Mar 2014 → Feb 2017 | osteomyelitis | Loyola University | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04009772 Comparator | Jul 2019 → Feb 2020 | skin infection | Assiut University | Unknown | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT03409679 Comparator | Mar 2018 → Jul 2019 | pneumonia | Polyphor Ltd. | Terminated | No outcome recorded |
| Phase 3 | NCT02795949 Comparator | Oct 2016 → Jan 2020 | bacterial infectious disease | Andalusian Public Foundation for Health Research in Seville | Completed | No outcome recorded |
| Phase 3 | NCT02820987 Comparator | Sep 2016 → Oct 2018 | infectious disease with sepsis | Centre Hospitalier Universitaire de Besancon | Completed | No outcome recorded |
| Phase 3 | NCT02302092 Comparator | Dec 2015 → Feb 2016 | urinary tract infection | Takeda | Terminated | No outcome recorded |
| Phase 3 | NCT00529282 Comparator | Oct 2007 → Jan 2008 | Pseudomonas infection, gram-positive bacterial infections, neutropenia | Basilea Pharmaceutica | Terminated | No outcome recorded |
| Phase 3 | NCT00137787 Comparator | Apr 2005 → Dec 2009 | neutropenia | Center for Supporting Hematology-Oncology Trials | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT07590648 Background | Jun 2026 → Jul 2028 expected | bacterial infectious disease, childhood malignant neoplasm, hematopoietic and lymphoid cell neoplasm, neutropenia | Hospital Universitari Vall d'Hebron Research Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06954129 Comparator | Jan 2026 → May 2029 expected | acute kidney injury | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 4 | NCT07072923 Comparator | Sep 2025 → Jul 2027 expected | osteomyelitis | University of Arizona | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05977868 Comparator | Aug 2023 → Feb 2025 | digestive system infectious disorder | West Virginia University | Terminated | No outcome recorded |
| Phase 4 | NCT05102162 Comparator | Dec 2021 → Feb 2023 | pneumonia | University of Florida | Terminated | No outcome recorded |
| Phase 4 | NCT05094154 Comparator | Nov 2021 → Oct 2022 | acute kidney injury, infectious disease with sepsis, poisoning | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT04042233 Comparator | Dec 2019 → May 2022 | periprosthetic joint infection | The Methodist Hospital Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT01667094 Comparator | Sep 2012 → Jul 2017 | cystic fibrosis | The Alfred | Unknown | No outcome recorded |
| Phase 4 | NCT02123628 Comparator | Jun 2007 → Jun 2010 | diabetes mellitus | Tourcoing Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00609375 Comparator | Sep 2006 → Dec 2007 | bacterial infectious disease, infectious disease with sepsis | Javeriana University | Completed | No outcome recorded |
| Phase 4 | NCT00358202 Comparator | Mar 2002 → Apr 2006 | pneumonia | CPL Associates | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06080698 Comparator | Feb 2024 → May 2027 expected | gram-negative bacterial infections | Johns Hopkins University | Recruiting | No outcome recorded |
| — | NCT01852630 Comparator | Dec 2012 → Dec 2015 | infectious peritonitis | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
Evidence & citations 26 cited values
Every value below carries the sentence it was read from. 72 sources stand behind the page.
| Field | Value | Cited 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 ↗ “FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV every eight hours (q8h)” NCT03630081 ↗ “3 g of zidebactam (1 g q8h) and 6 g of cefepime (2 g q8h) or 6” NCT02707107 ↗ “including cefepime, a fourth-generation cephalosporin” NCT05094154 ↗ “* Cefepime IV ou intra-muscularly 2g /8-12h” NCT02123628 ↗ “WCK 5222 (Cefepime and Zidebactam)” NCT03630094 ↗ “Cefepime 2 g IV/8-12h” NCT02795949 ↗ “Cefepime” NCT02099240 ↗ |
| 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 ↗ |
| 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 20191“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 ↗ |
| Route | Intravenous | “cefepime IV” NCT00020865 ↗ |