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ceftriaxone

Trade name: rocephin

Small moleculeapproved

Approved

Dec 21, 1984

Ceftriaxone is a broad-spectrum cephalosporin antibiotic with a very long half-life. Ceftriaxone is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Ceftriaxone has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria. It is approved for the treatment of lower respiratory tract infections, acute bacterial otitis media, skin infections, urinary tract infections, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intraabdominal infection, meningitis, and surgical prophylaxis. Common adverse reactions include erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, pseudomembranous enterocolitis, hemolytic anemia, hypersensitivity reaction, kernicterus, renal failure, and lung injury. Vancomycin, amsacrine, aminoglycosides, and fluconazole are incompatible with Ceftriaxone in admixtures. Precipitation of Ceftriaxone-calcium can occur when Ceftriaxone for Injection is mixed with calcium-containing solutions in the same intravenous administration line. — NCATS

Clinical trial activity

155 trials · 214 clinical orgs · 26 marketing orgs

Phase 1
12
Phase 2
68
Phase 3
44
Phase 4
50

Earliest trial started Jan 1, 1998 (NCT01559753)

Timeline

1980s

  1. Dec 21, 1984

    Roche — Earliest FDA Approval

  2. Dec 21, 1984

    Roche — NDA Organization

  3. Apr 30, 1987

    Roche — Marketing Organization

1990s

  1. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Sep 30, 2003

    Lupin — Marketing Organization

  2. Apr 20, 2005

    B. Braun — NDA Secondary Org

  3. May 3, 2005

    Novartis — Marketing Organization

  4. May 9, 2005

    Sandoz — Marketing Organization

  5. Aug 2, 2005

    Hospira — Marketing Organization

  6. Aug 23, 2005

    Baxalta — Marketing Organization

  7. Aug 23, 2005

    Baxter — Marketing Organization

  8. Feb 15, 2006

    Fresenius — Marketing Organization

  9. May 12, 2006

    Atlantide Pharmaceuticals — Marketing Organization

  10. May 12, 2006

    Wockhardt — Marketing Organization

  11. Feb 28, 2007

    facta — Marketing Organization

  12. Mar 15, 2007

    Teva — Marketing Organization

  13. Mar 26, 2007

    Cephazone Pharma — Marketing Organization

  14. Jan 11, 2008

    Akorn, Inc. — Marketing Organization

  15. Jan 11, 2008

    Epic Pharma Llc — Marketing Organization

  16. Jul 24, 2008

    ACS Dobfar — Marketing Organization

  17. Jul 31, 2008

    Aurobindo Pharma — Marketing Organization

  18. Aug 18, 2008

    Bedford Pharmaceuticals — Marketing Organization

2010s

  1. Jan 7, 2013

    Agila Specialties — Marketing Organization

  2. Apr 25, 2014

    Samson Medical — Marketing Organization

  3. Jun 29, 2016

    Qilu Pharmaceutical Co., Ltd. — Marketing Organization

  4. Jan 20, 2017

    Astral — Marketing Organization

  5. Jan 20, 2017

    ANDA Repository — Marketing Organization

  6. Oct 4, 2017

    Hikma — Marketing Organization

2020s

  1. Jan 12, 2024

    Deva Holding A.S. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewDec 21, 1984

Chemistry & pharmacology

Loading structure…

SMILES

CO/N=C(\C(=O)N[C@@H]1C(=O)N2C(C(=O)[O-])=C(CSc3nc(=O)c([O-])nn3C)CS[C@H]12)c1csc(N)n1.O.O.O.[Na+].[Na+]
Mol. weight
652.6 g/mol
Lipinski Ro5
2 violation(s)
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-{[(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-yl)sulfanyl]methyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
  • (6r,7r)-7-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-3-{[(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-yl)sulfanyl]methyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
  • biotrakson
  • cefatriaxone
  • cefatriaxone
  • ceftriaxne
  • ceftriaxona
  • ceftriaxona
  • ceftriaxone
  • ceftriaxone
  • ceftriaxone
  • ceftriaxone
  • ceftriaxone
  • ceftriaxone
  • ceftriaxone
  • ceftriaxone
  • ceftriaxone sodium
  • ceftriaxone sodium
  • ceftriaxone sodium
  • ceftriaxone sodium
  • ceftriaxone sodium
  • ceftriaxone sodium hydrate
  • ceftriaxone sodium hydrate
  • ceftriaxone sodium hydrate
  • ceftriaxone sodium hydrate
  • ceftriaxone sodium hydrate
  • ceftriaxone sodium hydrate
  • ceftriaxonum
  • ceftriaxonum
  • ceftriazone
  • ceftriazone
  • ceftrioxone
  • ro-139904
  • ro-139904
  • rocefin
  • rocephalin
  • rocephin
  • rocephin
  • rocephin
  • rophex

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06785402Phase 1/Phase 2 (Phase 2)Nov 15, 2025Hackensack University Medical Center
NCT06819592Phase 3Oct 30, 2025Monash University, Murdoch University, University of New South Wales, Wellington Hospital
NCT06611111Early Phase 1 (Phase 1)Nov 30, 2024State University of New York, Syracuse, Steven & Alexandra Cohen Children's Medical Center, New York
NCT06423898Phase 4Oct 9, 2024Fundación Pública Andaluza, IVI Sevilla, Spanish Clinical Research Network
NCT06532409N/AOct 1, 2024RESnTEC, Institute of Research
NCT06527989Phase 2/Phase 3 (Phase 3)Sep 1, 2024Assiut University
NCT07308457N/ASep 1, 2024Pomeranian Medical University
NCT06349122Phase 4Aug 31, 2024Aix-University of Marseille
NCT06494072Phase 4Aug 22, 2024Medical College of Wisconsin
NCT06396078Phase 4Jul 18, 2024Ohio State University
NCT07229755Phase 2/Phase 3 (Phase 3)Jul 1, 2024Ain Shams University
NCT06723782Phase 2Feb 15, 2024TBF Genie Tissulaire
NCT05943223Phase 2Jan 31, 2024McMaster University
NCT06220929Phase 4Jan 15, 2024Sichuan University
NCT06166381N/ADec 15, 2023Duhok University
NCT05761405Early Phase 1 (Phase 1)Oct 16, 2023Ecole Polytechnique Fédérale de Lausanne, University of Bern, University of Lausanne
NCT05971550Phase 3Sep 30, 2023Assistance Publique - Hôpitaux de Paris
NCT06616168Phase 1Sep 1, 2023Lviv National Medical University
NCT05750966N/AJul 19, 2023University of Amsterdam, ZonMw: The Netherlands Organisation for Health Research and Development
NCT05980871Phase 4Mar 10, 2023National Taiwan University
Showing 20 of 155 trials
Page 1 / 8

Organizations

Research & Development (214)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Allergy and Infectious Diseases (NIAID)Government9641999
PfizerFor profit8732001
Forest LaboratoriesFor profit6522007
MerckFor profit5532001
BayerFor profit4322004
University of OxfordAcademic/Hospital4442011
AstraZenecaFor profit3122011
Fundación Pública AndaluzaAcademic/Hospital3332014
GlaxoSmithKlineFor profit3131998
Makerere UniversityAcademic/Hospital3322006
RocheFor profit3131999
University of AmsterdamAcademic/Hospital3222014
University of LjubljanaAcademic/Hospital3312009
University of ParisAcademic/Hospital3312015
Ain Shams UniversityAcademic/Hospital2212013
Basilea PharmaceuticaFor profit2212006
Cairo UniversityAcademic/Hospital2222014
Capital Medical UniversityAcademic/Hospital2122022
Cempra IncFor profit2222012
Columbia UniversityAcademic/Hospital2011999
214 organizations
Page 1 / 11

Marketing (32)

OrganizationOrg typeRelationshipDate
ACS DobfarFor profitMKTGJul 24, 2008
ANDA RepositoryFor profitMKTGJan 20, 2017
Agila SpecialtiesFor profitMKTGJan 7, 2013
Akorn, Inc.For profitMKTGJan 11, 2008
Akorn, Inc.For profitSYNJan 11, 2008
AstralFor profitMKTGJan 20, 2017
Atlantide PharmaceuticalsFor profitMKTGMay 12, 2006
Aurobindo PharmaFor profitMKTGJul 31, 2008
B. BraunFor profitNDA2Apr 20, 2005
BaxaltaFor profitMKTGAug 23, 2005
BaxterFor profitMKTGAug 23, 2005
Bedford PharmaceuticalsFor profitMKTGAug 18, 2008
Cephazone PharmaFor profitMKTGMar 26, 2007
Deva Holding A.S.For profitMKTGJan 12, 2024
Epic Pharma LlcFor profitMKTGJan 11, 2008
FreseniusFor profitMKTGFeb 15, 2006
HikmaFor profitMKTGOct 4, 2017
HikmaFor profitSYNJan 10, 2008
HospiraFor profitMKTGAug 2, 2005
LupinFor profitMKTGSep 30, 2003
NovartisFor profitMKTGMay 3, 2005
Qilu Pharmaceutical Co., Ltd.For profitMKTGJun 29, 2016
Qilu Pharmaceutical Co., Ltd.For profitSYNJun 29, 2016
RocheFor profitNDADec 21, 1984
RocheFor profitMKTGApr 30, 1987
Samson MedicalFor profitMKTGApr 25, 2014
SandozFor profitMKTGMay 9, 2005
SandozFor profitSYNMay 3, 2005
TevaFor profitSYNMay 1, 2006
TevaFor profitMKTGMar 15, 2007
WockhardtFor profitMKTGMay 12, 2006
factaFor profitMKTGFeb 28, 2007