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cefepime

Trade name: maxipeme

Small moleculeapproved

Approved

Jan 18, 1996

Cefepime is a fourth-generation cephalosporin antibiotic, which was developed in 1994. Cefepime has a broad spectrum in vitro activity that encompasses a wide range of Gram-positive and Gram-negative bacteria. Within bacterial cells, the molecular targets of cefepime are the penicillin binding proteins (PBP). It is FDA approved for the treatment of pneumonia, febrile neutropenia, uncomplicated UTI, uncomplicated skin infection and complicated intraabdominal infections. Common adverse reactions include rash, hypophosphatemia, diarrhea. Cefepime is metabolized to N-methylpyrrolidine (NMP) which is rapidly converted to the N-oxide (NMP-N-oxide). Urinary recovery of unchanged cefepime accounts for approximately 85% of the administered dose. Less than 1% of the administered dose is recovered from urine as NMP, 6.8% as NMP-N-oxide, and 2.5% as an epimer of cefepime. Because renal excretion is a significant pathway of elimination, patients with renal dysfunction and patients undergoing hemodialysis require dosage adjustment. — NCATS

Clinical trial activity

61 trials · 82 clinical orgs · 15 marketing orgs

Phase 1
18
Phase 2
27
Phase 3
19
Phase 4
11

Earliest trial started Sep 1, 2001 (NCT00020865)

Timeline

1990s

  1. Jan 18, 1996

    Bristol-Myers Squibb — Earliest FDA Approval

  2. Jan 18, 1996

    Hospira — NDA Secondary Org

  3. Jan 18, 1996

    Bristol-Myers Squibb — NDA Organization

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  2. Jun 18, 2007

    Hospira — Marketing Organization

  3. Mar 20, 2008

    ACS Dobfar — Marketing Organization

  4. Aug 5, 2008

    Baxalta — NDA Secondary Org

  5. Aug 5, 2008

    Baxter — NDA Secondary Org

2010s

  1. May 6, 2010

    B. Braun — NDA Secondary Org

  2. Dec 21, 2010

    Fosun — Marketing Organization

  3. Dec 21, 2010

    Chartwell Pharmaceuticals — Marketing Organization

  4. Jan 1, 2011

    Earliest Phase 1 Sponsor(trial)

  5. Jan 1, 2014

    Earliest Phase 2 Sponsor(trial)

  6. Feb 1, 2016

    Qilu Pharmaceutical Co., Ltd. — Marketing Organization

  7. Jan 4, 2017

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  8. Jan 4, 2017

    Nichi-Iko Pharmaceutical Co., Ltd. — Marketing Organization

  9. Aug 21, 2018

    Samson Medical — Marketing Organization

2020s

  1. Jul 21, 2020

    Astral — Marketing Organization

  2. Feb 22, 2024

    Allecra — NDA Secondary Org

  3. May 22, 2024

    Hikma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • exblifep

    with Enmetazobactam

    Also known as cefepime and enmetazobactam, cefepime, enmetazobactam

Approval history

  • approvedJan 18, 1996

Chemistry & pharmacology

Loading structure…

SMILES

CO/N=C(\C(=O)N[C@@H]1C(=O)N2C(C(=O)[O-])=C(C[N+]3(C)CCCC3)CS[C@H]12)c1csc(N)n1
Mol. weight
480.57 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • (6r,7r)-7-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-3-[(1-methylpyrrolidinium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
  • (6r,7r)-7-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-3-[(1-methylpyrrolidinium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
  • axépim
  • bmy 28142
  • bmy-28142
  • bmy-28142
  • bmy-28142
  • bristol-myers brand of cefepime dihydrochloride
  • bristol-myers squibb brand of cefepime dihydrochloride
  • cefepim
  • cefepima
  • cefepima
  • cefepime
  • cefepime
  • cefepime
  • cefepime
  • cefepime
  • cefepime
  • cefepime
  • cefepime
  • cefepime
  • cefepime dihydrochloride hydrate
  • cefepime dihydrochloride hydrate
  • cefepime dihydrochloride hydrate
  • cefepime dihydrochloride hydrate
  • cefepime dihydrochloride hydrate
  • cefepime hcl
  • cefepime hcl
  • cefepime hcl
  • cefepime hydrochloride
  • cefepime hydrochloride
  • cefepime hydrochloride
  • cefepime hydrochloride
  • cefepime hydrochloride
  • cefepime hydrochloride (arginine formulation)
  • cefepime hydrochloride (arginine formulation)
  • cefepimum
  • cefepimum
  • cefimen
  • elan brand of cefepime dihydrochloride
  • maxipeme
  • maxipime
  • maxipime
  • maxipime
  • pyrrolidinium, 1-((7-(((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-en-3-yl)methyl)-1-methyl-, hydroxide, inner salt, (6r-(6alpha,7beta(z)))-
  • quadrocef
  • tsefepim
  • zidebactam
  • zidebactam
  • zidebactam

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06954129Phase 4Oct 31, 2025University of Pennsylvania
NCT06806995Phase 1Jan 21, 2025Eric Solutions LLC, Wockhardt
NCT06787885N/AMay 1, 2024Fayoum University
NCT06168734Phase 3Dec 31, 2023Department of Health and Human Services, VenatoRx Pharmaceuticals, Inc.
NCT05905055Phase 3Sep 22, 2023Meiji Seika Pharma Co., Ltd.
NCT05887908Phase 3May 23, 2023Meiji Seika Pharma Co., Ltd.
NCT05826990Phase 2Apr 15, 2023Allecra, Linical Co., Ltd.
NCT06048692Phase 3Jan 1, 2023Beni Suef University
NCT05645757Phase 1Dec 12, 2022National Institute of Allergy and Infectious Diseases (NIAID)
NCT04979806Phase 3Jan 31, 2022Medpace, Inc., Wockhardt
NCT05102162Phase 4Dec 31, 2021Food and Drug Administration, University of Florida
NCT05156437Phase 4Dec 20, 2021West Virginia University
NCT05588531Phase 1Dec 20, 2021Nanjing Yoko Biomedical Co., Ltd.
NCT05079620Phase 4Oct 5, 2021University of Connecticut
NCT04816968Phase 1Sep 30, 2021Revert ONLUS, University of Milan
NCT04983901Phase 2Sep 14, 2021University of Texas at Houston
NCT04948463Phase 4Jul 31, 2021Murdoch University
NCT04951505Phase 1Jun 29, 2021VenatoRx Pharmaceuticals, Inc.
NCT03840148Phase 3Jul 31, 2019VenatoRx Pharmaceuticals, Inc.
NCT04009772Phase 2/Phase 3 (Phase 3)Jul 1, 2019Assiut University
Showing 20 of 61 trials
Page 1 / 4

Organizations

Research & Development (82)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
WockhardtFor profit9922015
AllecraFor profit6632013
VenatoRx Pharmaceuticals, Inc.For profit6622017
Medpace, Inc.For profit4022017
Johnson and JohnsonFor profit3212007
ClinartisFor profit2012016
IQVIAFor profit2012015
Meiji Seika Pharma Co., Ltd.For profit2212023
National Cancer Institute (NCI)Government2022001
National Institute of Allergy and Infectious Diseases (NIAID)Government2112017
National Institutes of Health (NIH)Government2012018
University of Texas at HoustonAcademic/Hospital2212018
AllerganFor profit1012016
Asociacion Colombiana de InfectologiaAcademic/Hospital1012006
Assiut UniversityAcademic/Hospital1112019
AstraZenecaFor profit1112015
Baltic MedicineAcademic/Hospital1012018
Basilea PharmaceuticaFor profit1112007
BayerFor profit1012005
Beni Suef UniversityAcademic/Hospital1112023
82 organizations
Page 1 / 5

Marketing (18)

OrganizationOrg typeRelationshipDate
ACS DobfarFor profitMKTGMar 20, 2008
AllecraFor profitNDA2Feb 22, 2024
AstralFor profitMKTGJul 21, 2020
B. BraunFor profitNDA2May 6, 2010
BaxaltaFor profitNDA2Aug 5, 2008
BaxterFor profitNDA2Aug 5, 2008
Bristol-Myers SquibbFor profitNDAJan 18, 1996
Chartwell PharmaceuticalsFor profitMKTGDec 21, 2010
FosunFor profitMKTGDec 21, 2010
HikmaFor profitMKTGMay 22, 2024
HospiraFor profitNDA2Jan 18, 1996
HospiraFor profitMKTGJun 18, 2007
Nichi-Iko Pharmaceutical Co., Ltd.For profitMKTGJan 4, 2017
Qilu Pharmaceutical Co., Ltd.For profitMKTGFeb 1, 2016
Qilu Pharmaceutical Co., Ltd.For profitSYNFeb 1, 2016
Sagent Pharmaceuticals, Inc.For profitMKTGJan 4, 2017
Sagent Pharmaceuticals, Inc.For profitSYNJan 4, 2017
Samson MedicalFor profitMKTGAug 21, 2018