cefprozil

Trade name: cefzil

Small moleculeapproved

Approved

Dec 23, 1991

Cefprozil is a 2nd generation cephalosporin that is FDA approved for the treatment of mild to moderate infections of upper respiratory tract, lower respiratory tract, and uncomplicated skin and skin-structure infections. Cefprozil, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits the third and last stage of bacterial cell wall synthesis. Common adverse reactions include diarrhea, nausea, vomiting, dizziness, abdominal pain and vaginitis. Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporin antibiotics. Concomitant administration of probenecid doubled the AUC for cefprozil. — NCATS

Clinical trial activity

14 trials · 8 clinical orgs · 14 marketing orgs

Phase 1
9
Phase 2
0
Phase 3
0
Phase 4
1

Earliest trial started Sep 1, 2003 (NCT00840866)

Timeline

1990s

  1. Dec 23, 1991

    Earliest FDA Approval

  2. Dec 23, 1991

    Corden Pharma — NDA Secondary Org

  3. Dec 28, 1991

    Bristol-Myers Squibb — First NDA Organization

  4. Dec 28, 1991

    Bristol-Myers Squibb — NDA Organization

2000s

  1. Jan 1, 2003

    Teva — Earliest Phase 1 Sponsor(trial)

  2. Nov 14, 2005

    Chartwell Pharmaceuticals — Marketing Organization

  3. Nov 14, 2005

    CASI Pharmaceuticals, Inc. — Marketing Organization

  4. Dec 6, 2005

    Teva — Marketing Organization

  5. Dec 8, 2005

    Lupin — Marketing Organization

  6. Dec 8, 2005

    Sandoz — Marketing Organization

  7. Dec 8, 2005

    Novartis — Marketing Organization

  8. Dec 19, 2005

    Orchid Pharma — Marketing Organization

  9. Jun 30, 2006

    Ranbaxy — Marketing Organization

  10. Jan 30, 2007

    Aurobindo Pharma — Marketing Organization

  11. Jun 14, 2007

    Wockhardt — Marketing Organization

  12. Mar 26, 2008

    Apotex — Marketing Organization

2020s

  1. Apr 9, 2024

    Alkem Labs Ltd — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedDec 23, 1991

Chemistry & pharmacology

Loading structure…

SMILES

CC=CC1=C(C(=O)O)N2C(=O)[C@@H](NC(=O)[C@H](N)c3ccc(O)cc3)[C@H]2SC1
Mol. weight
389.43 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 7-(2-amino-2-(4-hydroxyphenyl)acetamido)-3-(propenyl)-3-cephem-4-carboxylic acid monohydrate
  • arzimol
  • bmy 28100
  • bmy-28100
  • bmy-28100-03-800
  • bmy-28100-03-800
  • brisoral
  • cefprozil
  • cefprozil
  • cefprozil
  • cefprozil
  • cefprozil
  • cefprozil
  • cefprozil
  • cefprozil
  • cefprozil
  • cefprozil
  • cefprozil
  • cefprozil anhydrous
  • cefprozil anhydrous
  • cefprozile
  • cefprozil hydrate
  • cefprozil monohydrate
  • cefprozilo
  • cefprozilo
  • cefprozilum
  • cefprozilum
  • cefzil
  • cefzil
  • cefzil
  • cefzil
  • cephprozyl
  • procef

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06494072Phase 4Aug 22, 2024Medical College of Wisconsin
NCT04414254Phase 1Sep 11, 2018Qingdao University
NCT00778739N/AJun 1, 2005Ranbaxy
NCT00778557N/AJun 1, 2005Ranbaxy
NCT00778245N/AMay 1, 2005Ranbaxy
NCT00778778N/AMay 1, 2005Ranbaxy
NCT00881400Phase 1Jun 1, 2004MDS Pharma, Sandoz
NCT00835354Phase 1May 1, 2004PRACS, Teva
NCT00881153Phase 1May 1, 2004MDS Pharma, Sandoz
NCT00835614Phase 1Apr 1, 2004PRACS, Teva
NCT00881426Phase 1Mar 1, 2004MDS Pharma, Sandoz
NCT00881855Phase 1Mar 1, 2004MDS Pharma, Sandoz
NCT00840281Phase 1Sep 1, 2003Gateway Medical Research, Teva
NCT00840866Phase 1Sep 1, 2003Gateway Medical Research, Teva
Showing 14 of 14 trials
Page 1 / 1

Organizations

Research & Development (8)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MDS PharmaFor profit4012004
RanbaxyFor profit4412005
SandozFor profit4412004
TevaFor profit4412003
Gateway Medical ResearchFor profit2012003
PRACSFor profit2012004
Medical College of WisconsinAcademic/Hospital1112024
Qingdao UniversityAcademic/Hospital1112018
8 organizations
Page 1 / 1

Marketing (16)

OrganizationOrg typeRelationshipDate
Alkem Labs LtdFor profitMKTGApr 9, 2024
ApotexFor profitMKTGMar 26, 2008
Aurobindo PharmaFor profitMKTGJan 30, 2007
Aurobindo PharmaFor profitSYNMay 24, 2007
Bristol-Myers SquibbFor profitNDADec 28, 1991
CASI Pharmaceuticals, Inc.For profitMKTGNov 14, 2005
Chartwell PharmaceuticalsFor profitMKTGNov 14, 2005
Corden PharmaFor profitNDA2Dec 23, 1991
LupinFor profitMKTGDec 8, 2005
NovartisFor profitMKTGDec 8, 2005
Orchid PharmaFor profitMKTGDec 19, 2005
RanbaxyFor profitMKTGJun 30, 2006
SandozFor profitMKTGDec 8, 2005
TevaFor profitMKTGDec 6, 2005
TevaFor profitSYNDec 8, 2005
WockhardtFor profitMKTGJun 14, 2007