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Rocephin

(ceftriaxone)

ApprovedSmall molecule

CConrado Roberto Hoffmann Filho

Ceftriaxone is an antibiotic used to treat bacterial infections throughout the body, including pneumonia, meningitis, urinary tract infections, and sexually transmitted infections like gonorrhea.[2] Rocephin is currently approved and in use across 24 indications[4].[1]

Rocephin is one of 251 small molecule programs targeting Complicated Appendicitis. It is currently in Approved.

24

Indications

87

Total Trials

10

Active Trials

250

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Complicated AppendicitisApproved

Amyotrophic Lateral SclerosisApproved

ShigellosisApproved

OsteomyelitisApproved

EndometritisApproved

SepsisApproved

Post-Treatment Lyme Disease SyndromeApproved

EndocarditisApproved

Bacterial DiseaseActive, not recruiting

Parkinson DiseaseApproved

Complicated AppendicitisApproved

Approved

Amyotrophic Lateral SclerosisApproved

Approved

ShigellosisApproved

Approved

OsteomyelitisApproved

Approved

EndometritisApproved

Approved

SepsisApproved

Approved

Post-Treatment Lyme Disease SyndromeApproved

Approved

EndocarditisApproved

Approved

Bacterial DiseaseApproved

Active, not recruiting

Parkinson DiseaseApproved

Approved

Showing 10 of 24 indications

Competition

Competitive Landscape

155 competitors in Pneumonia

#DrugCompanyPhaseTrials

Rocephin

CConrado Roberto Hoffmann Filho

Innohep

Jazz Pharmaceuticals

Plaquenil

Jazz Pharmaceuticals

Prevacid

Acanya

Jakafi

Primaquine

Avlosulfon

AAlmirall, S.A.

Zantac 150

Virazole

CConrado Roberto Hoffmann Filho

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Colonization

NCT02996656

Post-ApprovalRecruiting

PPROM

NCT06396078

Phase 1Recruiting

Lyme Disease

NCT06611111

Q4 2027

Hematopoietic Cell Transplant

NCT07308457

Q1 2028

Phase 3Recruiting

Pneumonia

NCT02735707

ApprovedNot yet recruiting

Community Acquired Pneumonia (CAP)

NCT07537413

Clinical

Trials by Indication[1]

Pneumonia7 trials

Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

Completed·HHospital Universitario Principe de Asturias·Phase 4·NCT00374959·80 enrolled

Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia

Completed·CCPL Associates·Phase 4·NCT00358202·69 enrolled

Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia

Completed· Pfizer logo

Pfizer·Phase 4·NCT00035347·219 enrolled

Show 4 more trials

Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children

Completed·MMakerere University·Phase 3·NCT00372541·348 enrolled

A Study to Compare Different Antibiotics and Different Modes of Fluid Treatment for Children With Severe Pneumonia

Completed·UUniversity of Oxford·Phase 3·NCT04041791·4,392 enrolled

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Recruiting·UUMC Utrecht·Phase 3·NCT02735707·20,000 enrolled

Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia

Completed·FForest Laboratories·Phase 3·NCT00509106·622 enrolled

Gonorrhea4 trials

Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea

Terminated·MMelinta Therapeutics, Inc.·Phase 3·NCT02015637·460 enrolled

A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea

Completed· GSK logo

GSK·Phase 3·NCT04010539·628 enrolled

Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT02257918·180 enrolled

Show 1 more trial

Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea

Completed·MMelinta Therapeutics, Inc.·Phase 3·NCT02210325·264 enrolled

Lyme disease4 trials

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000938·66 enrolled

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001101·194 enrolled

Brain Imaging and Retreatment Study of Persistent Lyme Disease

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 2·NCT00037479·65 enrolled

Show 1 more trial

Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease

Recruiting·SState University of New York - Upstate Medical University·Phase 1·NCT06611111·44 enrolled

Lyme Neuroborreliosis4 trials

Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

Unknown status·UUniversity Medical Centre Ljubljana·N/A·NCT00942006·200 enrolled

Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

Completed·SSorlandet Hospital HF·Phase 3·NCT00138801·120 enrolled

Study on Early Lyme Neuroborreliosis

Unknown status·UUniversity Medical Centre Ljubljana·N/A·NCT00910533·50 enrolled

Show 1 more trial

Study of Lyme Neuroborreliosis

Completed·TTurku University Hospital·Phase 4·NCT01635530·210 enrolled

Experimental3 trials

Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT05294588·65 enrolled

Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT04870138·16 enrolled

Experimental Human Infection With Neisseria Gonorrhoeae

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT03840811·27 enrolled

55 more indications

Antibiotic3 trials

Optimising Antibiotic Treatment for Sick Malnourished Children

Unknown status·UUniversity of Oxford·Phase 2·NCT02746276·81 enrolled

New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea

Completed·PPublic Health Service of Amsterdam·Phase 3·NCT03294395·346 enrolled

Prophylactic Antibiotic in Subtalar Fusion Surgery

Not yet recruiting·—·Phase 2/3·NCT06527989·102 enrolled

Bacterial Pneumonia3 trials

A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia

Completed· Roche logo

Roche·Phase 2·NCT00111644·302 enrolled

Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)

Completed·FForest Laboratories·Phase 2/3·NCT01530763·161 enrolled

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

Completed· Pfizer logo

Pfizer·Phase 3·NCT01371838·848 enrolled

Urinary Tract Infection2 trials

Antibiotic Treatment for 7 Days Versus 14 Days in Patients With Acute Male Urinary Tract Infection

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02424461·274 enrolled

Comparison Between Effect of Empirical Antibiotic Prophylaxis Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy in Children With Pyuria

Completed·—·Phase 2/3·NCT07229755·140 enrolled

Appendicitis2 trials

Antibiotic Instillation in Appendicitis

Completed·JJohns Hopkins All Children's Hospital·Phase 2·NCT05470517·190 enrolled

Assessing the Longitudinal Outcomes of Piperacillin/Tazobactam Versus ceftriAxone and Metronidazole for Children With Perforated Appendicitis (ALPACA): a Randomized Controlled Trial

Completed·MMcMaster Children's Hospital·Phase 2·NCT05943223·16 enrolled

Intravenous2 trials

Crossover Study to Compare the Pharmacokinetics of Subcutaneous and Intravenous Ceftriaxone Administration

Completed·SscPharmaceuticals, Inc.·Phase 2/3·NCT02561442·18 enrolled

Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP

Completed·KKangbuk Samsung Hospital·Phase 2·NCT02098486·86 enrolled

Antibiotics2 trials

Prophylactic Antibiotics in Admitted Cirrhotics

Completed·—·Phase 4·NCT04218695·32 enrolled

Early Antibiotics After Aspiration in ICU Patients

Terminated·UUConn Health·Phase 4·NCT05079620·5 enrolled

Liver abscess2 trials

Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess

Completed·KKaohsiung Veterans General Hospital.·Phase 4·NCT00895089·24 enrolled

Antibiotics for Klebsiella Liver Abscess Study

Completed·NNational University Hospital, Singapore·Phase 4·NCT01723150·152 enrolled

Pyelonephritis2 trials

Impact on the Intestinal Microbiota of Treatment With Ceftriaxone in Women's Acute Community Pyelonephritis

Completed·—·Phase 4·NCT03179384·9 enrolled

Efficacy and Safety Study of Short Term Antibiotic During Seven Days With Ceftriaxone Intravenous the First Day Then Cefixime the Second Day Till the Seventh Day of Acute Uncomplicated Pyelonephritis in Women Between 18 and 65 Years Old

Completed·UUniversity Hospital, Clermont-Ferrand·Approved·NCT01390623·39 enrolled

Pelvic Inflammatory Disease1 trial

The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)

Completed·HHarold Wiesenfeld·Phase 2·NCT01160640·233 enrolled

Acute Variceal Bleeding1 trial

RCT to Determine the Efficacy of Combining Hemospray With Medical Treatment in Acute Variceal Bleeding

Completed·TTheodor Bilharz Research Institute·N/A·NCT03061604·105 enrolled

Randomized1 trial

Clearance of Asymptomatic Pharyngeal Carriage of Neisseria Gonorrhoeae With or Without Ceftriaxone Treatment: Randomized Non-inferiority Study

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT05971550·254 enrolled

Colonization1 trial

Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery

Recruiting·UUniversité de Montréal·N/A·NCT02996656·88 enrolled

Complicated Appendicitis1 trial

Risk Factors of Failure of Conservative Treatment in Acute Non Complicated Appendicitis

Not yet recruiting·AAhmed Mohammed Hussein Sayed··NCT06828952·100 enrolled

Peritonitis1 trial

Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?

Unknown status·TTanta University·Phase 3·NCT02443285·100 enrolled

Kidney Stone1 trial

A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])

Completed·UUniversity of California, San Diego·Phase 4·NCT02384200·86 enrolled

Cholangitis1 trial

Antibiotics to Decrease Post ERCP Cholangitis

Unknown status·UUniversity of Southern California·Phase 4·NCT03087656·200 enrolled

Microbiota1 trial

Impact of the Choice of 3rd Generation Cephalosporins on the Emergence of Resistance in the Microbiota Intestinal.

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02659033·22 enrolled

Adult1 trial

A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy

Completed·TTheriva Biologics, Inc.·Phase 1/2·NCT02473640·15 enrolled

Jaundice1 trial

Ceftriaxone and Jaundice in Neonates

Completed·UUniversity of Rochester··NCT03133637·27 enrolled

Typhoid Fever1 trial

Typhoid Fever: Combined vs. Single Antibiotic Therapy

Unknown status·SSheba Medical Center·Phase 4·NCT02224040·120 enrolled

Skin Infection1 trial

Comparing the Intravenous Treatment of Skin Infections in Children, Home Versus Hospital

Completed·MMurdoch Childrens Research Institute·N/A·NCT02334124·190 enrolled

Enterocolitis1 trial

The Role of Short-course Ceftriaxone Therapy in the Treatment of Severe Nontyphoidal Salmonella Enterocolitis

Unknown status·—·Phase 4·NCT01278017·200 enrolled

Bronchitis1 trial

Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis

Terminated·UUniversity Hospital, Lille·Phase 4·NCT03012360·103 enrolled

Knee Arthroscopy1 trial

PROPER Trial of Pain and Inflammation After Knee Arthroscopy

Terminated·AAustin V Stone·Phase 2·NCT05149287·5 enrolled

Malnutrition1 trial

First Line Antimicrobials in Children With Complicated Severe Acute Malnutrition

Unknown status·UUniversity of Oxford·Phase 3·NCT03174236·2,000 enrolled

TED1 trial

Zoliflodacin in Uncomplicated Gonorrhoea

Completed·GGlobal Antibiotics Research and Development Partnership·Phase 3·NCT03959527·1,011 enrolled

Pneumococcal Pneumonia1 trial

Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia

Terminated·HHospital Mutua de Terrassa·Phase 4·NCT00429975·45 enrolled

Infections1 trial

Ceftriaxone as Home IV for Staph Infections

Unknown status·VVancouver Island Health Authority·Phase 4·NCT04141787·310 enrolled

Cesarean Section1 trial

The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section

Unknown status·—·Phase 2·NCT02742948·600 enrolled

Psychosis1 trial

A Placebo-controlled Efficacy Study of IV Ceftriaxone for Refractory Psychosis

Terminated·RResearch Foundation for Mental Hygiene, Inc.·Phase 1/2·NCT00591318·12 enrolled

Ciprofloxacin1 trial

Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of SBP in Patients With LC

Completed·KKorea University·Phase 4·NCT01265173·261 enrolled

Prosthetic-joint Infection1 trial

Efficacy and Safety Study of Antibiotic Treatment to Treat Hip Prosthetic Joint Infection

Unknown status·UUniversity Hospital, Tours·Phase 2·NCT01757236·100 enrolled

Antibiotic Prophylaxis1 trial

Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Completed·NNorthwestern University·Phase 4·NCT01659866·563 enrolled

Enteric Fever1 trial

Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

Completed·OOxford University Clinical Research Unit, Vietnam·Phase 4·NCT01421693·300 enrolled

Function1 trial

Penile Fracture: A Comparison of Erectile Function After Immediate Repair Versus Delayed Repair

Completed·MMinistry of Health, Jamaica·N/A·NCT03449940·46 enrolled

Stroke1 trial

Propranolol on Post Stroke Immune Status and Infection

Unknown status·TTianjin Medical University General Hospital·Phase 2·NCT05375240·45 enrolled

Bipolar Depression1 trial

Ceftriaxone in the Management of Bipolar Depression

Terminated·YYale University·N/A·NCT00566111·5 enrolled

Open Fracture1 trial

Noninferiority Comparison of Prophylactic Open Fracture Antimicrobial Regimens

Terminated·MMercy Health Ohio·Phase 4·NCT03560232·17 enrolled

Syphilis1 trial

Treatment Responses of Early Syphilis to Ceftriaxone Plus Doxycycline

Terminated·NNational Taiwan University Hospital·Phase 4·NCT05980871·109 enrolled

Erythema1 trial

Antibiotic Treatment of Multiple Erythema Migrans

Unknown status·UUniversity Medical Centre Ljubljana·N/A·NCT01163994·500 enrolled

Ulcerative Colitis1 trial

Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 2·NCT03794765·50 enrolled

PPROM1 trial

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

Recruiting·OOhio State University·Phase 4·NCT06396078·56 enrolled

Clinical Trial1 trial

Clinical Trial Ceftriaxone in Subjects With ALS

Completed·MMassachusetts General Hospital·Phase 3·NCT00349622·513 enrolled

Immunology1 trial

Chlamydia Trachomatis Immunology and Vaccinology Study

Completed·HHarold Wiesenfeld··NCT01150747·347 enrolled

Drug Resistance1 trial

Fosfomycin Versus Meropenem or Ceftriaxone in Bacteriemic Infections Caused by Multidrug Resistance in E.Coli

Completed·FFundación Pública Andaluza para la gestión de la Investigación en Sevilla·Phase 3·NCT02142751·161 enrolled

Neurosurgery1 trial

Cefuroxime vs Ceftriaxone for SSI Prevention in Neurosurgery

Completed·—·Phase 2·NCT05398081·96 enrolled

Hematopoietic Cell Transplant1 trial

Enhanced Molecular Microbiological Surveillance Versus Ceftriaxone Prophylaxis in Hematopoietic Cell Transplant Patients

Recruiting·PPomeranian Medical University Szczecin·N/A·NCT07308457·100 enrolled

Sepsis1 trial

Prehospital Antibiotics Against Sepsis Trial

Completed·AAmsterdam UMC, location VUmc·N/A·NCT01988428·2,672 enrolled

Bipolar Disorder1 trial

A Glutamate Transporter GLT1, in the Treatment of Bipolar Disorder

Withdrawn·NNational Institute of Mental Health (NIMH)·Phase 2·NCT00512616

Community Acquired Pneumonia (CAP)1 trial

Pragmatic Randomized Trial Evaluating Dosage of Ceftriaxone for Community-Acquired Pneumonia Outside the Intensive Care Unit

Not yet recruiting·UUniversity of Maryland, Baltimore·Approved·NCT07537413·900 enrolled

Mortality1 trial

PRophylaxis Against Early VENTilator-associated Infections to Reduce Mortality in Mechanically Ventilated Intensive Care Unit (ICU) Patients With Acute Brain Injuries: a Phase 3 Randomised, Double Blind, Parallel Group, Placebo-controlled Two-side Superiority Trial

Recruiting·TThe George Institute·Phase 3·NCT06819592·3,300 enrolled

Bacterial Vaginosis1 trial

Screen-and-treat Strategy for Vaginal Flora Abnormalities by Molecular Biology in Pregnant Women at High Risk of Preterm Birth: A Multicentre, Randomized Study (AUTOP 2)

Not yet recruiting·AAssistance Publique Hopitaux De Marseille·Phase 3·NCT06349122·1,794 enrolled

Intensive Care Unit1 trial

Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02473263·398 enrolled

Parkinson's Disease Dementia1 trial

A Randomized, Double Blinded, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia

Completed·BBrainX Corporation·Phase 2·NCT03413384·100 enrolled

Unspecified1 trial

Pharmacokinetic of Ceftriaxone in Septic ICU Patients

Unknown status·AAssociation Pour La Promotion A Tours De La Reanimation Medicale·Phase 4·NCT00449800·70 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 21, 1984

ROCEPHIN

NDA NDA050585

Feb 11, 1987

ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER

NDA NDA050624

Apr 20, 2005

CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER

NDA NDA050796

Sources

References

[1]
ClinicalTrials.gov — 87 trial records for ceftriaxone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Rocephin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — ceftriaxone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for ceftriaxone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050796). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Conrado Roberto Hoffmann Filho company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bacterial Penicillin-Binding Protein Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CConrado Roberto Hoffmann Filho

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