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cephalexin

Trade name: keflex

Small moleculeapproved

Approved

Jan 4, 1971

Cephalexin is a semisynthetic cephalosporin antibiotic intended for oral administration. In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell-wall synthesis. Cephalexin has been shown to be active against most strains of the following microorganisms both in vitro: Staphylococcus aureus (including penicillinase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains), Streptococcus pyogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella (Branhamella) catarrhalis, Proteus mirabilis. Cephalexin is indicated for the treatment of the respiratory tract, skin and skin structure, bone and genitourinary tract infections when caused by susceptible strains of the designated microorganisms. — NCATS

Clinical trial activity

82 trials · 116 clinical orgs · 22 marketing orgs

Phase 1
19
Phase 2
18
Phase 3
12
Phase 4
25

Earliest trial started Apr 1, 1999 (NCT00003824)

Timeline

1970s

  1. Jan 4, 1971

    Pragma Therapeutics — Earliest FDA Approval

  2. Jan 4, 1971

    Pragma Therapeutics — NDA Secondary Org

  3. Jan 4, 1971

    Pragma Therapeutics — NDA Organization

  4. Oct 12, 1972

    Eli Lilly — Marketing Organization

  5. Oct 12, 1972

    Eli Lilly — NDA Secondary Org

  6. Apr 26, 1976

    Teva — Marketing Organization

  7. Mar 27, 1978

    facta — Marketing Organization

1980s

  1. Apr 22, 1987

    Barr Laboratories — Marketing Organization

  2. Mar 17, 1988

    Jerome Stevens Pharmaceuticals — Marketing Organization

  3. Jun 20, 1988

    Welfide — Marketing Organization

  4. Jul 15, 1988

    Belcher Pharmaceuticals — Marketing Organization

  5. Jul 15, 1988

    AJENAT PHARMS — Marketing Organization

  6. Jan 9, 1989

    Vitarine — Marketing Organization

  7. Jul 25, 1989

    Apothecon — Marketing Organization

1990s

  1. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

  2. Sep 16, 1999

    Sun Pharmaceuticals — Marketing Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Sep 11, 2003

    Ranbaxy — Marketing Organization

  3. Feb 24, 2005

    Yung Shin Pharm. Ind. Co., Ltd. — Marketing Organization

  4. Feb 24, 2005

    Chartwell Pharmaceuticals — Marketing Organization

  5. Jun 28, 2005

    Orchid Pharma — Marketing Organization

  6. Jun 28, 2005

    ANDA Repository — Marketing Organization

  7. Aug 17, 2005

    Lupin — Marketing Organization

  8. Nov 16, 2005

    Aurobindo Pharma — Marketing Organization

  9. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

  10. Aug 28, 2009

    Hikma — Marketing Organization

2010s

  1. Dec 20, 2010

    Alkem Labs Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJan 4, 1971

Chemistry & pharmacology

Loading structure…

SMILES

CC1=C(N2[C@H](SC1)[C@H](NC(=O)[C@H](N)C3=CC=CC=C3)C2=O)C(O)=O
Mol. weight
347.389 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 66873
  • 66873
  • (6r,7r)-7-{[(2r)-2-amino-2-phenylacetyl]amino}-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
  • (6r,7r)-7-{[(2r)-2-amino-2-phenylacetyl]amino}-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
  • 7-beta-(d-alpha-amino-alpha-phenylacetylamino)-3-methyl-3-cephem-4-carboxylic acid
  • 7-beta-(d-alpha-amino-alpha-phenylacetylamino)-3-methyl-3-cephem-4-carboxylic acid
  • 7-(d-alpha-aminophenylacetamido)desacetoxycephalosporanic acid
  • 7-(d-alpha-aminophenylacetamido)desacetoxycephalosporanic acid
  • anhydrous cefalexin
  • anhydrous cefalexin
  • anhydrous cephalexin
  • anhydrous cephalexin
  • biocef
  • biocef
  • cefalexin
  • cefalexin
  • cefalexin
  • cefalexin
  • cefalexin
  • cefalexin
  • cefalexina
  • cefalexina
  • cefalexin anhydrous
  • cefalexin anhydrous
  • céfalexine
  • céfalexine
  • cefalexin hcl
  • cefalexin hydrate
  • cefalexin hydrate
  • cefalexin hydrochloride
  • cefalexin hydrochloride
  • cefalexin hydrochloride
  • cefalexin hydrochloride
  • cefalexin hydrochloride
  • cefalexin hydrochloride
  • cefalexinum
  • cefalexinum
  • cephacillin
  • cephalexin
  • cephalexin
  • cephalexin
  • cephalexin
  • cephalexin
  • cephalexin
  • cephalexin
  • cephalexin
  • cephalexin anhydrous
  • cephalexin anhydrous
  • cephalexin anhydrous
  • cephalexin hcl
  • cephalexin hcl
  • cephalexin hcl
  • cephalexin hydrate
  • cephalexin hydrate
  • cephalexin hydrate
  • cephalexin hydrochloride
  • cephalexin hydrochloride
  • cephalexin hydrochloride
  • cephalexin hydrochloride
  • cephalosporin
  • cephalosporin
  • ceporex
  • ceporex
  • keflet
  • keflet
  • keflex
  • keflex
  • keflex
  • keflex
  • keftab
  • keftab
  • kiflone
  • ly-061188
  • ly-061188
  • panixine disperdose
  • panixine disperdose
  • tenkorex

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07300670Phase 1Feb 28, 2026University of Helsinki, University of Turku
NCT06336824Phase 3Jun 28, 2024Clinical Research Centre, Malaysia, Government of Malaysia
NCT06127160Phase 4Jan 31, 2024University of California, Los Angeles, University of Iowa
NCT06055712Phase 4Sep 11, 2023St. Louis University
NCT05852262Phase 4Aug 30, 2023University of Ottawa
NCT05849090Early Phase 1 (Phase 1)Mar 27, 2023University of Utah
NCT05664568Phase 2Jan 31, 2023University of Sydney, Western Sydney Local Health District
NCT05274672Phase 4Mar 1, 2022Baylor Scott and White, Baylor University, Yeshiva University
NCT05156437Phase 4Dec 20, 2021West Virginia University
NCT05094154Phase 4Nov 10, 2021Vanderbilt University
NCT05020574Phase 2Sep 28, 2021The Plastic Surgery Foundation, University of California, San Francisco
NCT04916951Phase 1Jul 14, 2021University of Colorado, University of Colorado, Denver
NCT04876131Phase 4Jun 30, 2021Murdoch University, University of Melbourne
NCT04834310Phase 4Apr 1, 2021University of California, Los Angeles
NCT04577846Phase 3Nov 1, 2020Aga Khan University, Dow University of Health Sciences, Liaquat University of Medical & Health Sciences
NCT04471246Early Phase 1 (Phase 1)Nov 1, 2020Canadian Association of Emergency Physicians, University of Ottawa
NCT04580472Phase 4Oct 31, 2020Virginia Polytechnic Institute and State University
NCT04538053Phase 4Sep 30, 2020Murdoch University
NCT04401553Phase 4Aug 31, 2020The University of Texas, Dallas
NCT04553419Phase 3Jul 27, 2020University of British Columbia, University of Toronto
Showing 20 of 82 trials
Page 1 / 5

Organizations

Research & Development (116)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Eli LillyFor profit5512014
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.Academic/Hospital5012014
BayerFor profit3312009
Corporación Bonima S.A. de C.V.For profit3012009
GlaxoSmithKlineFor profit3312009
University of British ColumbiaAcademic/Hospital3222009
Ain Shams UniversityAcademic/Hospital2222019
Capital Medical UniversityAcademic/Hospital2122010
MerckFor profit2122012
Murdoch UniversityAcademic/Hospital2212020
National Cancer Institute (NCI)Government2121999
National Institute of Allergy and Infectious Diseases (NIAID)Government2122009
State University of New YorkAcademic/Hospital2212010
University of California, Los AngelesAcademic/Hospital2112021
University of California, San FranciscoAcademic/Hospital2222004
University of Colorado, DenverAcademic/Hospital2212019
University of IowaAcademic/Hospital2212020
University of OttawaAcademic/Hospital2222020
University of PennsylvaniaAcademic/Hospital2222009
Vanderbilt UniversityAcademic/Hospital2222016
116 organizations
Page 1 / 6

Marketing (28)

OrganizationOrg typeRelationshipDate
AJENAT PHARMSFor profitMKTGJul 15, 1988
ANDA RepositoryFor profitMKTGJun 28, 2005
Alkem Labs LtdFor profitMKTGDec 20, 2010
ApotheconFor profitMKTGJul 25, 1989
Aurobindo PharmaFor profitSYNNov 16, 2005
Aurobindo PharmaFor profitMKTGNov 16, 2005
Barr LaboratoriesFor profitMKTGApr 22, 1987
Belcher PharmaceuticalsFor profitMKTGJul 15, 1988
Chartwell PharmaceuticalsFor profitMKTGFeb 24, 2005
Eli LillyFor profitMKTGOct 12, 1972
Eli LillyFor profitNDA2Oct 12, 1972
HikmaFor profitSYNJan 24, 2006
HikmaFor profitMKTGAug 28, 2009
Jerome Stevens PharmaceuticalsFor profitMKTGMar 17, 1988
LupinFor profitMKTGAug 17, 2005
Orchid PharmaFor profitMKTGJun 28, 2005
Pragma TherapeuticsFor profitNDA2Jan 4, 1971
Pragma TherapeuticsFor profitNDAJan 4, 1971
Puracap PharmaceuticalFor profitMKTG—
RanbaxyFor profitMKTGSep 11, 2003
Sun PharmaceuticalsFor profitSYNJun 11, 1987
Sun PharmaceuticalsFor profitMKTGSep 16, 1999
TevaFor profitMKTGApr 26, 1976
TevaFor profitSYNFeb 13, 1987
VitarineFor profitMKTGJan 9, 1989
WelfideFor profitMKTGJun 20, 1988
Yung Shin Pharm. Ind. Co., Ltd.For profitMKTGFeb 24, 2005
factaFor profitMKTGMar 27, 1978