TheraRadar
Data updated: May 26, 2026

CEFTRIAXONE (ceftriaxone sodium)

Trial Activity: Declining 3 active trials
Infectious Disease Approved 2003-09-30

CEFTRIAXONE is indicated for the treatment of Lower Respiratory Tract Infection; Acute Bacterial Otitis Media.

Source: FDA Label • Hikma
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

Development Insights

Assistance Publique - Hôpitaux de Paris conducting 3 trials (8%)
48 indications explored (Broad Platform)
→ gonorrhea (4 trials)
→ gonococcal infection (2 trials)
→ infection (2 trials)
26
Indications
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2003-09-30
Routes
INTRAMUSCULAR, INTRAVENOUS, INJECTION
Dosage Forms
INJECTABLE

Companies

Hikma Pfizer ACS DOBFAR SAMSON MEDCL QILU ANTIBIOTICS DEVA HOLDING AS Teva Fresenius Kabi Novartis Aurobindo Pharma AGILA SPECLTS ASTRAL Lupin FACTA FARMA CEPHAZONE PHARMA BEDFORD Apotex WOCKHARDT BIO AG EPIC PHARMA LLC
Active Ingredient: CEFTRIAXONE SODIUM

CEFTRIAXONE Approval History

2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
409 FDA actions from 2003 to 2024
Jan 2024 ORIGINAL
Update
Jan 2022 SUPPL
Label · Labeling
Sep 2020 SUPPL
Label · Labeling

What CEFTRIAXONE Treats

2 indications

CEFTRIAXONE is approved for 2 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Lower Respiratory Tract Infection
  • Acute Bacterial Otitis Media
Source: FDA Label

CEFTRIAXONE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

CONTEPO
MEITHEAL
2025 2 indic.
ENFLONSIA
Merck
2025 1 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CEFTRIAXONE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AMOXICILLIN PEDIATRIC
AMOXICILLIN
2 shared
Teva
Shared indications:
Lower Respiratory Tract InfectionAcute Bacterial Otitis Media
AUGMENTIN '125'
AMOXICILLIN
2 shared
US ANTIBIOTICS
Shared indications:
Lower Respiratory Tract InfectionAcute Bacterial Otitis Media
AUGMENTIN '250'
AMOXICILLIN
2 shared
US ANTIBIOTICS
Shared indications:
Lower Respiratory Tract InfectionAcute Bacterial Otitis Media
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📋

Clinical Trial Registry

41 trials
Trial Sponsor ID Phase Status Title
NCT05294588 21-0498 DMID 21-0018, U01AI162457-01 Ph 2 completed Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae
NCT05980871 results posted 202206138MIND Ph 4 terminated Treatment Responses of Early Syphilis to Ceftriaxone Plus Doxycycline
NCT05079620 results posted 22-004-02 Ph 4 terminated Early Antibiotics After Aspiration in ICU Patients
NCT03012360 TAVeM2 2015_66 2016-000735-41 Ph 4 terminated Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis
NCT02473263 SSS 2014-A01030-47 Ph 3 completed Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock
NCT03959527 results posted STI_Zoli001 2019-000990-22 Ph 3 completed Zoliflodacin in Uncomplicated Gonorrhoea
NCT03413384 BRICEFA20170414 Ph 2 active not recruiting To Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia
NCT04975945 generalsurgery/2021/01 Ph 4 withdrawn Assessing Parenteral Antibiotics Versus Single-time Intra-operative Intra-dermal Antibiotic Administration for Prevention of SSI
NCT05470517 results posted IRB00323208 Ph 2 completed Antibiotic Instillation in Appendicitis
NCT02735707 REMAP-CAP U1111-1189-1653 2015-002340-14, 602525 Ph 3 recruiting Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
NCT04041791 SEARCH KEMRI/CGMR-C/141/3772 Ph 3 completed A Study to Compare Different Antibiotics and Different Modes of Fluid Treatment for Children With Severe Pneumonia
NCT04010539 results posted 116577 2018-001780-23 Ph 3 completed A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
NCT02424461 PROSTASHORT P120116 AOM12268 Ph 3 completed Antibiotic Treatment for 7 Days Versus 14 Days in Patients With Acute Male Urinary Tract Infection
NCT06349122 AUTOP2 2023-509421-41-00 Ph 4 not yet recruiting Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth
NCT03179384 CEFIMPACT 16-AOI-02 Ph 4 completed Impact on the Intestinal Microbiota of Treatment With Ceftriaxone in Women's Acute Community Pyelonephritis
NCT05149287 PROPER results posted 63476 Ph 2 terminated PROPER Trial of Pain and Inflammation After Knee Arthroscopy
NCT04218695 results posted 2020P000050 BIDMC-ABX-pilot-19 Ph 4 completed Prophylactic Antibiotics in Admitted Cirrhotics
NCT04870138 results posted 09-0106 LptA Ph 1 completed Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)
NCT03294395 NABOGO NABOGO Ph 3 completed New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea
NCT03840811 results posted 09-0106 Ph 1 completed Experimental Human Infection With Neisseria Gonorrhoeae
NCT03794765 AAASUC NK/5147/DM Ph 2 completed Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis
NCT03560232 17-028 Ph 4 terminated Noninferiority Comparison of Prophylactic Open Fracture Antimicrobial Regimens
NCT02384200 results posted 160405 150013 Ph 4 completed A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])
NCT01659866 results posted STU00059558 EAM-237 Ph 4 completed Antibiotic Prophylaxis for Transrectal Prostate Biopsy
NCT01635530 T1/2012 Ph 4 completed Study of Lyme Neuroborreliosis
NCT02473640 results posted SB-1-004-004 Ph 1, Ph 2 completed A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy
NCT01723150 A-KLASS Ph 4 completed Antibiotics for Klebsiella Liver Abscess Study
NCT01160640 results posted PRO10010112 1U19AI084024-01 Ph 2 completed The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)
NCT02015637 results posted ML-3341-304 Ph 3 terminated Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea
NCT02659033 CEREMI CRC13-179 / P140904 2014-005485-30 Ph 3 completed Impact of the Choice of 3rd Generation Cephalosporins on the Emergence of Resistance in the Microbiota Intestinal.
NCT02210325 SOLITAIRE-U CE01-302 15-0091, HHSN272201300013 Ph 3 completed Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea
NCT01371838 results posted D3720C00002 Ph 3 completed A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia
NCT02561442 scP-02-001 Ph 2, Ph 3 completed Crossover Study to Compare the Pharmacokinetics of Subcutaneous and Intravenous Ceftriaxone Administration
NCT02257918 results posted 14-0014 HHSN272201300012I Ph 2 completed Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea
NCT01254344 results posted 0826-056 Ph 3 completed Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
NCT01421693 03NP Ph 4 completed Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever
NCT02098486 ERCPMOXIVSCEF Ph 2 completed Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP
NCT00895089 VGHKS98-CT2-20 Ph 4 completed Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess
NCT01530763 P903-31 Ph 2, Ph 3 completed Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)
NCT01390623 CHU-0098 2010-023697-39 Ph 4 completed Efficacy and Safety Study of Short-term Antibiotic for Pyelonephritis in Women
NCT01473836 results posted A6831005 Ph 3 completed A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CEFTRIAXONE FDA Label Details

Indications & Usage

FDA Label (PDF)

CEFTRIAXONE is indicated for the treatment of Lower Respiratory Tract Infection; Acute Bacterial Otitis Media.

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Data Sources

FDA Approval: ANDA065342 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment