Ceftin

(cefuroxime)

ApprovedSmall molecule

Cefuroxime is an antibiotic used to treat bacterial infections such as respiratory tract infections, urinary tract infections, skin infections, and Lyme disease.[2] Ceftin is currently approved and in use across 16 indications[4].[1]

Ceftin is one of 275 small molecule programs targeting Bacterial Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

274

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Bacterial DiseaseActive, not recruiting

Respiratory Tract InfectionActive, not recruiting

EndophthalmitisActive, not recruiting

AppendicitisActive, not recruiting

PyelonephritisActive, not recruiting

PneumoniaActive, not recruiting

Infectious DiseaseActive, not recruiting

Acute BronchitisActive, not recruiting

Total Knee ArthroplastyActive, not recruiting

Eye InfectionActive, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

Respiratory Tract InfectionPhase 1

Active, not recruiting

EndophthalmitisPreclinical

Active, not recruiting

AppendicitisPreclinical

Active, not recruiting

PyelonephritisApproved

Active, not recruiting

PneumoniaPhase 3

Active, not recruiting

Infectious DiseasePreclinical

Active, not recruiting

Acute BronchitisApproved

Active, not recruiting

Total Knee ArthroplastyApproved

Active, not recruiting

Eye InfectionApproved

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

547 competitors in Pneumonia

#DrugCompanyPhaseTrials

Ceftin

PPhiladelphia Eye Associates

Approved

1 2

Primaxin

Pfizer

Preclinical

2 3

Zantac 150

CChattem

Preclinical

2 4

Tagamet

DDT MedTech, LLC

Preclinical

1 5

Pepcid

KKenvue Brands

Preclinical

1 6

Hydroxychloroquine Sulfate

Novartis

Preclinical

1 7

PCV13

Sanofi

Preclinical

1 8

Foscavir

NNational Institute of Allergy and Infectious Diseases (NIAID)

Preclinical

—9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Angiotensin Receptor Blockers

TThe George Institute

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Post-ApprovalRecruiting

Antibiotic Prophylaxis

NCT06709196

Q4 2027

Post-ApprovalRecruiting

Pyelonephritis

NCT06527560

Q4 2028

Phase 2Recruiting

Acute Uncomplicated Diverticulitis

NCT07492134

Clinical

Trials by Indication[1]

Antibiotic Prophylaxis5 trials

Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis

Recruiting·RRigshospitalet, Denmark·Phase 4·NCT06709196·248 enrolled

Antibiotic Prophylaxis for Transrectal Prostate Biopsy

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

Antibiotic Prophylaxis in Total Knee Prosthesis

Completed·HHospital Clinic of Barcelona·Phase 4·NCT00497341·1,332 enrolled

Show 2 more trials

Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections

Completed·HHannover Medical School·Phase 4·NCT01080963·650 enrolled

Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)

Recruiting·LLeiden University Medical Center·Phase 4·NCT05784311·344 enrolled

Antibiotics2 trials

Tailored Antibiotics Prophylaxis for Percutaneous Endoscopic Gastrostomy

Unknown status·NNational Cheng Kung University·N/A·NCT01237730·100 enrolled

The Preventive Infection Role of One Week Antibiotics Before Minimally Invasive Upper Tract Lithotomy

Unknown status·XXinhua Hospital, Shanghai Jiao Tong University School of Medicine·Phase 1·NCT02789579·150 enrolled

Colorectal Surgery2 trials

Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis

Completed·HHospital Universitari Vall d'Hebron Research Institute·Phase 4·NCT02505581·536 enrolled

Colo-Pro_2: Bolus-continuous Infusion Cefuroxime Prophylaxis for the Prevention of Infections After Colorectal Surgery

Recruiting·UUniversity of Leeds·Phase 2·NCT05609240·180 enrolled

Hernia1 trial

Study of the Efficacy of Preoperative Cefuroxime Prophylaxis to Prevent Surgical Site Infection in Herniated Disk Surgery

Completed·—·Phase 4·NCT00530400·1,369 enrolled

Cesarean Section1 trial

Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section

Completed·—·Phase 4·NCT01138852·176 enrolled

21 more indications

Pyelonephritis1 trial

Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis

Recruiting·HHospital de Clinicas de Porto Alegre·Phase 4·NCT06527560·100 enrolled

Antibiotic1 trial

Prophylactic Antibiotic Treatment During Vaginal Repair

Unknown status·HHvidovre University Hospital·N/A·NCT00162604·200 enrolled

Total Knee Arthroplasty1 trial

Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

Completed·SSeoul National University Hospital·Phase 4·NCT00901628·101 enrolled

Efficacy1 trial

Efficacy of Local Powder Prophylactics

Unknown status·—·N/A·NCT01372371·1,844 enrolled

Randomized Controlled Trial1 trial

Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial.

Unknown status·HHospital Universitari Vall d'Hebron Research Institute·Phase 4·NCT04161599·968 enrolled

Age1 trial

Adequacy of Perioperative Cefuroxime Dosage According to the BMI

Completed·UUniversitätsklinikum Hamburg-Eppendorf·Phase 4·NCT03141476·60 enrolled

Surgical Site Infection1 trial

Prevention of Surgical Site Infection in Open Paediatric Groin Surgeries Using Intravenous Prophylactic Antibiotics and Antimicrobial-coated Sutures

Recruiting·OOlawumi Olajide·N/A·NCT07346742·174 enrolled

Neurosurgery1 trial

Cefuroxime vs Ceftriaxone for SSI Prevention in Neurosurgery

Completed·—·Phase 2·NCT05398081·96 enrolled

Ulcerative Colitis1 trial

Antibiotics for the Treatment of Ulcerative Colitis

Completed·UUniversity of Dundee·N/A·NCT00355602·40 enrolled

Effectiveness1 trial

Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates

Unknown status·SShandong University··NCT05388747·100 enrolled

Cardiac Surgery1 trial

Pharmacokinetics of Post Operative Cefuroxime in Infants Undergoing Cardiac Surgery

Withdrawn·AAlder Hey Children's NHS Foundation Trust··NCT02850250

Cataract1 trial

The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery

Completed·—·N/A·NCT00730938·45 enrolled

Prophylaxis1 trial

24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis

Completed·SSaud Al Babtain Cardiac Center·Phase 4·NCT04303390·568 enrolled

Gut Microbiota1 trial

Antibiotics and Gut Microbiota Among Newborn Infants

Completed·OOdense University Hospital·Phase 4·NCT02072798·42 enrolled

Critically Ill Patients1 trial

Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients.

Unknown status·RRadboud University Medical Center··NCT04470973·40 enrolled

Postoperative Infections1 trial

RCT of Postoperative Infections Following Caesarean Section Infections Following Caesarean Section

Withdrawn·OOdense University Hospital·Phase 4·NCT02009098

Respiratory tract infection1 trial

Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection

Unknown status·ZZhong Wang·Phase 1·NCT04479657·60 enrolled

Endophthalmitis1 trial

Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery

Completed·—·N/A·NCT00136344·35,000 enrolled

Pneumonia1 trial

An Open, Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin Versus Cefuroxime Alone or With Oral Erythromycin for the Treatment of Chinese Patients Who Were Hospitalized for Pneumonia

Completed· Pfizer logo

Pfizer·Phase 3·NCT00648726·139 enrolled

Acute Uncomplicated Diverticulitis1 trial

Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis

Recruiting·VVanderbilt University Medical Center·Phase 2·NCT07492134·100 enrolled

Unspecified1 trial

Intracameral Levofloxacin (0.5%) vs Intracameral Cefuroxime

Unknown status·NNational University of Malaysia·Phase 1/2·NCT04212078·138 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 19, 1983

ZINACEF

NDA NDA050558

Apr 28, 1989

ZINACEF IN PLASTIC CONTAINER

NDA NDA050643

Feb 21, 2001

CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER

NDA NDA050780

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for cefuroxime. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ceftin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — cefuroxime compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for cefuroxime. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050780). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Philadelphia Eye Associates 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: PPhiladelphia Eye Associates

Ceftin

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Q4 2028

Trials by Indication[1]

Antibiotic Prophylaxis5 trials

Antibiotics2 trials

Colorectal Surgery2 trials

Hernia1 trial

Cesarean Section1 trial

Pyelonephritis1 trial

Antibiotic1 trial

Total Knee Arthroplasty1 trial

Efficacy1 trial

Randomized Controlled Trial1 trial

Age1 trial

Surgical Site Infection1 trial

Neurosurgery1 trial

Ulcerative Colitis1 trial

Effectiveness1 trial

Cardiac Surgery1 trial

Cataract1 trial

Prophylaxis1 trial

Gut Microbiota1 trial

Critically Ill Patients1 trial

Postoperative Infections1 trial

Respiratory tract infection1 trial

Endophthalmitis1 trial

Pneumonia1 trial

Acute Uncomplicated Diverticulitis1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News