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cefuroxime plus erythromycin
cefuroxime plus erythromycin is a Beta-lactam antibiotic + macrolide antibiotic combination Small molecule drug developed by Pfizer. It is currently in Phase 3 development for Community-acquired respiratory tract infections, Bacterial pneumonia with atypical pathogen coverage.
This combination uses cefuroxime (a beta-lactam antibiotic) to inhibit bacterial cell wall synthesis and erythromycin (a macrolide) to inhibit bacterial protein synthesis, providing broad-spectrum coverage against respiratory pathogens.
This combination uses cefuroxime (a beta-lactam antibiotic) to inhibit bacterial cell wall synthesis and erythromycin (a macrolide) to inhibit bacterial protein synthesis, providing broad-spectrum coverage against respiratory pathogens. Used for Community-acquired respiratory tract infections, Bacterial pneumonia with atypical pathogen coverage.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline. -
Big-pharma sponsor
+3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | cefuroxime plus erythromycin |
|---|---|
| Sponsor | Pfizer |
| Drug class | Beta-lactam antibiotic + macrolide antibiotic combination |
| Target | Bacterial cell wall (penicillin-binding proteins) and bacterial 50S ribosome |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Cefuroxime is a second-generation cephalosporin that binds to penicillin-binding proteins and disrupts peptidoglycan cross-linking in bacterial cell walls, leading to cell lysis. Erythromycin is a macrolide antibiotic that binds to the bacterial 50S ribosomal subunit and inhibits protein synthesis. Together, they provide synergistic activity against common respiratory bacteria including Streptococcus pneumoniae, Haemophilus influenzae, and atypical organisms.
Approved indications
- Community-acquired respiratory tract infections
- Bacterial pneumonia with atypical pathogen coverage
Common side effects
- Gastrointestinal disturbance (nausea, diarrhea)
- Abdominal pain
- Rash
- Headache
- Hypersensitivity reaction
Key clinical trials
- Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections (NA)
- Patients Response to Early Switch To Oral:Osteomyelitis Study (EARLY_PHASE1)
- Physiotherapy in Patients Hospitalized Due to Pneumonia. (NA)
- The Optimization of Mycoplasm Pneumonia Antibiotic Therapy (NA)
- Procalcitonin as a Marker of Antibiotic Therapy in Patients With Lower Respiratory Tract Infections (PHASE4)
- Risk of Acute Liver Injury in Users of Antimicrobials
- 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 (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- cefuroxime plus erythromycin CI brief — competitive landscape report
- cefuroxime plus erythromycin updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about cefuroxime plus erythromycin
What is cefuroxime plus erythromycin?
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Related
- Drug class: All Beta-lactam antibiotic + macrolide antibiotic combination drugs
- Target: All drugs targeting Bacterial cell wall (penicillin-binding proteins) and bacterial 50S ribosome
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Community-acquired respiratory tract infections
- Indication: Drugs for Bacterial pneumonia with atypical pathogen coverage
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing