CEFUROXIME · Hikma
Cefuroxime for Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Lower Respiratory Tract Infections , including pneumonia, caused by Streptococcus pneumoniae , Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non–penicillinase-producing strains), Streptococcus pyogenes , and Escherichia coli .
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-01-09
- Routes
- Injection
- Dosage Forms
- Injectable
CEFUROXIME Approval History
What CEFUROXIME Treats
8 indicationsCEFUROXIME is approved for 8 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
CEFUROXIME Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 CEFUROXIME
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07492134 | 251398 1R01DK141523-01A1 | Ph 2 | not yet recruiting | APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis) |
| NCT06709196 REINFORCE | 2024-514312-27-00 2024-514312-27-00 | Ph 4 | recruiting | Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis |
| NCT05784311 SPARROW | NL82304.058.22 | Ph 4 | recruiting | Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW) |
| NCT06527560 CEFURO | 2024-0118 | Ph 4 | recruiting | Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis |
| NCT05609240 | 315251 | Ph 2 | recruiting | Colo-Pro_2: Bolus-continuous Infusion Cefuroxime Prophylaxis for the Prevention of Infections After Colorectal Surgery |
| NCT04303390 | SBCC-2017-14 | Ph 4 | completed | 24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis |
| NCT01659866 results posted | STU00059558 EAM-237 | Ph 4 | completed | Antibiotic Prophylaxis for Transrectal Prostate Biopsy |
| NCT00497341 | PTR2007 | Ph 4 | completed | Antibiotic Prophylaxis in Total Knee Prosthesis |
| NCT02009098 APIPICS | 2012-002068-29 2012-002068-29 | Ph 4 | withdrawn | RCT of Postoperative Infections Following Caesarean Section Infections Following Caesarean Section |
| NCT02072798 | s-20130117 2012-002068-29 | Ph 4 | completed | Antibiotics and Gut Microbiota Among Newborn Infants |
| NCT00901628 results posted | B-0804/056-021 | Ph 4 | completed | Periarticular Multimodal Drug Injections in Total Knee Arthroplasty |
| NCT01080963 DaPro | CCBC134ADAPRO 2007-004611-61 | Ph 4 | completed | Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
CEFUROXIME FDA Label Details
Indications & Usage
Cefuroxime for Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Lower Respiratory Tract Infections , including pneumonia, caused by Streptococcus pneumoniae , Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non–penicillinase-producing strains), Streptococcus pyogenes , and Escherichia coli . Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. Skin and Skin-Structure Infections caused by Staphylo...
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Data Sources
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