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Coamoxiclav
Coamoxiclav is a Small molecule drug developed by University of Dundee. It is currently in Phase 1 development.
Co-amoxiclav, also known as Augmentin, is a small molecule antibiotic medication used to treat bacterial infections. It is a combination of amoxicillin, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor, and is specifically used to treat conditions such as otitis media and acute bacterial sinusitis.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Coamoxiclav |
|---|---|
| Sponsor | University of Dundee |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Acupuncture and Herbal Treatment of Chronic HIV Sinusitis (NA)
- Bacteriological Study of Acute Follicular Tonsillitis in Patients Attending the ENT Outpatient Clinic of Assiut University Hospital (N/A)
- A Prospective Randomised Controlled Non-inferiority Study to Evaluate the Effectiveness and Safety (APRES) of Non-operative Management in Children With Acute Uncomplicated Appendicitis (NA)
- Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial (Phase 4)
- NCT04082598 (Phase 4)
- A Study to Determine PK Profiles of AUGMENTIN XR in Adolescents Weight at Least 40 kg Receiving Augmentin XR BID for 10 Days (Phase 1)
- Effects of Pre-operative Antibiotics on the Wound Healing Following Clinical Crown Lengthening Surgery (Phase 4)
- Comparison The Postoperative Effects Of Local Antibiotic Versus Systemic Antibiotic With The Use Of Platelet Rich Fibrin On The Mandibular Third Molar Surgery (N/A)
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:
- Coamoxiclav CI brief — competitive landscape report
- Coamoxiclav updates RSS · CI watch RSS
- University of Dundee portfolio CI
Frequently asked questions about Coamoxiclav
What is Coamoxiclav?
Who makes Coamoxiclav?
What development phase is Coamoxiclav in?
Related
- Manufacturer: University of Dundee — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing