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cefdinir

Trade name: omnicef

Small moleculeapproved

Approved

Dec 4, 1997

Cefdinir is an extended-spectrum, semisynthetic cephalosporin, for oral administration. As with other cephalosporins, bactericidal activity of cefdinir results from inhibition of cell wall synthesis. Cefdinir is stable in the presence of some, but not all, β-lactamase enzymes. Cefdinir is indicated for the treatment of: Community-Acquired Pneumonia, Acute Exacerbations of Chronic Bronchitis, Acute Maxillary Sinusitis, Pharyngitis/Tonsillitis and Uncomplicated Skin and Skin Structure Infections. Side effects include diarrhea, vaginal infections or inflammation, nausea, headache, and abdominal pain. Concomitant administration of 300-mg cefdinir capsules with 30 mL Maalox® TC suspension reduces the rate (Cmax) and extent (AUC) of absorption by approximately 40%. As with other β-lactam antibiotics, probenecid inhibits the renal excretion of cefdinir. — NCATS

Clinical trial activity

24 trials · 19 clinical orgs · 10 marketing orgs

Phase 1
9
Phase 2
0
Phase 3
2
Phase 4
12

Earliest trial started Jul 1, 2002 (NCT00645203)

Timeline

1990s

  1. Dec 4, 1997

    AbbVie — Earliest FDA Approval

  2. Dec 4, 1997

    AbbVie — NDA Organization

  3. Dec 4, 1997

    AbbVie — NDA Secondary Org

2000s

  1. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2005

    Teva — Earliest Phase 1 Sponsor(trial)

  3. May 19, 2006

    Lupin — Marketing Organization

  4. Apr 6, 2007

    Chartwell Pharmaceuticals — Marketing Organization

  5. Apr 6, 2007

    Sandoz — Marketing Organization

  6. Apr 6, 2007

    Novartis — Marketing Organization

  7. May 4, 2007

    Teva — Marketing Organization

  8. Jul 18, 2007

    Orchid Pharma — Marketing Organization

  9. Jul 18, 2007

    ANDA Repository — Marketing Organization

  10. Dec 14, 2007

    Aurobindo Pharma — Marketing Organization

2020s

  1. Feb 19, 2021

    Alkem Labs Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 4, 1997

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC(=CS1)C(=N\O)\C(=O)N[C@H]2[C@H]3SCC(C=C)=C(N3C2=O)C(O)=O
Mol. weight
395.414 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • (6r,7r)-7-{2-(2-amino-thiazol-4-yl)-2-[(z)-hydroxyimino]-acetylamino}-8-oxo-3-vinyl-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid
  • (6r,7r)-7-{2-(2-amino-thiazol-4-yl)-2-[(z)-hydroxyimino]-acetylamino}-8-oxo-3-vinyl-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid
  • (6r,7r,z)-7-(2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamido)-8-oxo-3-vinyl-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid
  • (6r,7r,z)-7-(2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamido)-8-oxo-3-vinyl-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid
  • 7-(2 (2-aminothiazol-4-yl)-2-hydroxyiminoacetamido)-3-vinyl-3-cephem-4-carboxylic acid
  • abbott brand of cefdinir
  • cefdiel
  • cefdinir
  • cefdinir
  • cefdinir
  • cefdinir
  • cefdinir
  • cefdinir
  • cefdinir
  • cefdinir
  • cefdinir
  • cefdinir
  • cefdinir monohydrate
  • cefdinir monohydrate
  • cefdinir monohydrate
  • cefdinir monohydrate
  • cefdinir monohydrate
  • cefdinirum
  • cefdinirum
  • cefinir
  • cefnil
  • cefzon
  • cefzon
  • cefzon
  • cfdn
  • cfdn
  • cfdn
  • ci 983
  • ci-983
  • ci-983
  • ci-983
  • fk 482
  • fk-482
  • fk-482
  • fk-482
  • omnicef
  • omnicef
  • omnicef
  • omnicef
  • pd 134393
  • pd-134393

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03756324Phase 2/Phase 3 (Phase 3)Dec 20, 2018Capital Medical University, Peking University
NCT03400735Phase 4Nov 1, 2017NeuTec Pharma
NCT03014687Phase 4Jan 1, 2017Barrow Neurological Institute, Thomas Jefferson University, University of Arizona, University of Rochester
NCT02891915Phase 4Oct 4, 2016National Institute of Allergy and Infectious Diseases (NIAID)
NCT04664803Phase 4Aug 31, 2015Korea United Pharm. Inc.
NCT02447224Early Phase 1 (Phase 1)Oct 1, 2014National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Los Angeles
NCT01000298N/ADec 1, 2009Washington University in St. Louis
NCT00835484Phase 1Jul 1, 2005PRACS, Teva
NCT00834535Phase 1Jul 1, 2005PRACS, Teva
NCT00882700Phase 1Apr 1, 2005Sandoz, SFBC Anapharm
NCT00882570Phase 1Apr 1, 2005Sandoz, SFBC Anapharm
NCT00883883Phase 1Apr 1, 2005Sandoz, SFBC Anapharm
NCT00882154Phase 1Apr 1, 2005Sandoz, SFBC Anapharm
NCT00835549Phase 1Mar 1, 2005Novum Pharmaceutical Research Services, Teva
NCT00234949Phase 4Mar 1, 2005Abbott
NCT00147914Phase 4Feb 1, 2005University of Chicago
NCT00834574Phase 1Feb 1, 2005Novum Pharmaceutical Research Services, Teva
NCT00645112Phase 4Nov 1, 2003Abbott
NCT00645073Phase 4Nov 1, 2003Abbott
NCT00644943Phase 4Feb 1, 2003Abbott
Showing 20 of 24 trials
Page 1 / 2

Organizations

Research & Development (19)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AbbottFor profit8822002
SandozFor profit4412005
SFBC AnapharmFor profit4012005
TevaFor profit4412005
Novum Pharmaceutical Research ServicesFor profit2012005
PRACSFor profit2012005
Barrow Neurological InstituteAcademic/Hospital1012017
Capital Medical UniversityAcademic/Hospital1012018
Korea United Pharm. Inc.For profit1112015
National Institute of Allergy and Infectious Diseases (NIAID)Government1112016
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government1012014
NeuTec PharmaFor profit1112017
Peking UniversityAcademic/Hospital1112018
Thomas Jefferson UniversityAcademic/Hospital1012017
University of ArizonaAcademic/Hospital1112017
University of California, Los AngelesAcademic/Hospital1112014
University of ChicagoAcademic/Hospital1112005
University of RochesterAcademic/Hospital1012017
Washington University in St. LouisAcademic/Hospital1112009
19 organizations
Page 1 / 1

Marketing (11)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGJul 18, 2007
AbbVieFor profitNDADec 4, 1997
AbbVieFor profitNDA2Dec 4, 1997
Alkem Labs LtdFor profitMKTGFeb 19, 2021
Aurobindo PharmaFor profitMKTGDec 14, 2007
Chartwell PharmaceuticalsFor profitMKTGApr 6, 2007
LupinFor profitMKTGMay 19, 2006
NovartisFor profitMKTGApr 6, 2007
Orchid PharmaFor profitMKTGJul 18, 2007
SandozFor profitMKTGApr 6, 2007
TevaFor profitMKTGMay 4, 2007