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Amoxicilline/clavulanic
Amoxicilline/clavulanic is a Beta-lactam antibiotic with beta-lactamase inhibitor Small molecule drug developed by Bayer. It is currently in Phase 3 development for Bacterial infections caused by beta-lactamase-producing organisms (respiratory tract infections, urinary tract infections, skin and soft tissue infections, otitis media).
Amoxicillin/clavulanic acid is a beta-lactam antibiotic combination that kills bacteria by inhibiting cell wall synthesis, with clavulanic acid protecting amoxicillin from degradation by bacterial beta-lactamases.
Amoxicillin-clavulanic acid is a small molecule antibiotic used to treat various infections, including osteomyelitis, complicated appendicitis, and infections during hemodialysis. It is administered orally or intravenously, typically in a dose of 40mg/kg three times a day, with a maximum daily dose of 3g.
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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
Bayer 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 | Amoxicilline/clavulanic |
|---|---|
| Sponsor | Bayer |
| Drug class | Beta-lactam antibiotic with beta-lactamase inhibitor |
| Target | Bacterial penicillin-binding proteins; bacterial beta-lactamases |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Amoxicillin works by binding to penicillin-binding proteins and inhibiting bacterial cell wall cross-linking, leading to cell lysis and death. Clavulanic acid is a beta-lactamase inhibitor that irreversibly binds to and inactivates bacterial beta-lactamases, preventing them from destroying amoxicillin and extending its spectrum of activity against beta-lactamase-producing organisms.
Approved indications
- Bacterial infections caused by beta-lactamase-producing organisms (respiratory tract infections, urinary tract infections, skin and soft tissue infections, otitis media)
Common side effects
- Diarrhea
- Nausea
- Vomiting
- Rash
- Abdominal pain
- Allergic reactions
Key clinical trials
- APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis) (PHASE2)
- Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics (PHASE4)
- Efficacy of an Empirical Treatment With Amoxicillin-clavulanate (AC) Compared to the Combination Amoxicillin-clavulanate and Ciprofloxacin (AC+C) in the Outpatient Care of Chemotherapy-induced Fever in Adult Haematology Patients. (PHASE3)
- Amoxicillin/Clavulanic Acid Susceptibility in Acute Community-acquired Pneumonia Requiring Intensive Care Management
- Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children (PHASE2)
- Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis (PHASE4)
- Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP (PHASE4)
- Collaborative Urological Prosthetics Investigation Directive Research Group (EARLY_PHASE1)
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:
- Amoxicilline/clavulanic CI brief — competitive landscape report
- Amoxicilline/clavulanic updates RSS · CI watch RSS
- Bayer portfolio CI
Frequently asked questions about Amoxicilline/clavulanic
What is Amoxicilline/clavulanic?
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What does Amoxicilline/clavulanic target?
Related
- Drug class: All Beta-lactam antibiotic with beta-lactamase inhibitor drugs
- Target: All drugs targeting Bacterial penicillin-binding proteins; bacterial beta-lactamases
- Manufacturer: Bayer — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Bacterial infections caused by beta-lactamase-producing organisms (respiratory tract infections, urinary tract infections, skin and soft tissue infections, otitis media)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing