Clavulanic acid
Amoxicillin / Clavulanate Potassium, Augmentin, Timentin (clavulanic acid) is a small molecule pharmaceutical. Clavulanic acid was first approved as Augmentin '250' on 1984-08-06. It is used to treat haemophilus infections, otitis media, and staphylococcal infections in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| otorhinolaryngologic diseases | D010038 |
Trade Name
FDA
EMA
Combinations
Amoxicillin clavulanate potassium, Augmentin (discontinued: Amoxicillin clavulanate potassium, Augmentin, Timentin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amoxicillin
+
Clavulanate potassium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AUGMENTIN '125' | USAntibiotics | N-050575 RX | 1984-08-06 | 1 products, RLD |
| AUGMENTIN '250' | USAntibiotics | N-050575 RX | 1984-08-06 | 1 products, RLD, RS |
| AUGMENTIN ES-600 | USAntibiotics | N-050755 RX | 2001-06-22 | 1 products, RLD |
| AUGMENTIN '875' | USAntibiotics | N-050720 RX | 1996-02-13 | 1 products, RLD |
Show 9 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amoclan | 2009-01-07 | |
| amoxicillan and clavulanate potassium | ANDA | 2014-08-01 |
| amoxicillin | ANDA | 2020-06-19 |
| amoxicillin amoxicillin and clavulanate potassium | ANDA | 2024-01-09 |
| amoxicillin and clavulanate potassium | ANDA | 2025-02-10 |
| amoxicillin and clavulanate potassium extended release | New Drug Application | 2011-04-07 |
| amoxicillin clavulanate potassium | 2006-11-03 | |
| augmentin | New Drug Application | 2025-01-08 |
| augmentin es-600 | New Drug Application | 2024-12-24 |
| augmentinxr | New Drug Application | 2010-11-22 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
329 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 2 | 6 | 20 | 26 | 18 | 68 |
| Communicable diseases | D003141 | — | — | — | 3 | 12 | 15 | 11 | 40 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 5 | 14 | 12 | 4 | 32 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | 5 | 14 | 8 | 27 |
| Appendicitis | D001064 | EFO_0007149 | K37 | 1 | 1 | 2 | 4 | 14 | 22 |
| Otitis media | D010033 | EFO_0004992 | H66.9 | — | 2 | 4 | 5 | 4 | 15 |
| Otitis | D010031 | — | — | — | 2 | 4 | 6 | 3 | 15 |
| Rhinosinusitis | D000096825 | — | — | — | 1 | 1 | 5 | 5 | 12 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 1 | 6 | 3 | 3 | 12 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 1 | 8 | — | 1 | 1 | 11 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intraabdominal infections | D059413 | — | — | — | 1 | 5 | — | — | 6 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | 2 | — | 2 | — | 1 | 5 |
| Neutropenia | D009503 | — | D70 | — | — | 3 | — | 2 | 5 |
| Covid-19 | D000086382 | — | U07.1 | — | — | 2 | — | 2 | 4 |
| Abscess | D000038 | EFO_0003030 | — | — | — | 3 | — | 1 | 4 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | 2 | — | 1 | 4 |
| Cholecystitis | D002764 | — | K81 | — | — | 1 | — | 2 | 3 |
| Acalculous cholecystitis | D042101 | EFO_1000790 | — | — | — | 1 | — | 2 | 3 |
| Hyperthermia | D000084462 | — | — | — | — | 2 | — | 1 | 3 |
| Fistula | D005402 | — | — | — | 1 | 1 | — | 1 | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 6 | — | — | — | 6 |
| Cocaine-related disorders | D019970 | — | F14 | 3 | 1 | — | — | — | 4 |
| Drug therapy | D004358 | — | — | — | 1 | — | — | 1 | 2 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | 1 | 2 |
| Empyema | D004653 | EFO_0003097 | — | — | 1 | — | — | 1 | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 1 | — | — | 1 | 2 |
| Depression | D003863 | — | F33.9 | — | 2 | — | — | — | 2 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 2 | — | — | — | 2 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 2 | — | — | — | 2 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 1 | 1 | — | — | — | 2 |
Show 12 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | — | — | — | 5 | 13 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | 1 | — | — | — | 2 | 3 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | 2 | 3 |
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Prosthesis-related infections | D016459 | EFO_1001406 | — | 1 | — | — | — | 1 | 2 |
| Jaw fractures | D007572 | — | — | 1 | — | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
| Astrocytoma | D001254 | EFO_0000271 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | — | — | — | — | 4 | 4 |
| Bisphosphonate-associated osteonecrosis of the jaw | D059266 | — | — | — | — | — | — | 2 | 2 |
| Acute cholecystitis | D041881 | EFO_1001289 | K81.0 | — | — | — | — | 2 | 2 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | — | — | 2 | 2 |
| Enterococcus | D016983 | — | — | — | — | — | — | 2 | 2 |
| Bronchiectasis | D001987 | — | J47 | — | — | — | — | 2 | 2 |
| Tonsillitis | D014069 | — | — | — | — | — | — | 2 | 2 |
| Thyroid nodule | D016606 | EFO_1001436 | — | — | — | — | — | 2 | 2 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | — | — | — | 2 | 2 |
| Periapical periodontitis | D010485 | EFO_1001391 | K04.5 | — | — | — | — | 2 | 2 |
Show 65 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Clavulanic acid |
| INN | clavulanic acid |
| Description | Clavulanic acid is antibiotic isolated from Streptomyces clavuligerus. It acts as a suicide inhibitor of bacterial beta-lactamase enzymes. It has a role as an antibacterial drug, a bacterial metabolite, an anxiolytic drug and an EC 3.5.2.6 (beta-lactamase) inhibitor. It is a conjugate acid of a clavulanate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)[C@H]1/C(=C/CO)O[C@@H]2CC(=O)N21 |
Identifiers
| PDB | — |
| CAS-ID | 58001-44-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL777 |
| ChEBI ID | 48947 |
| PubChem CID | 5280980 |
| DrugBank | DB00766 |
| UNII ID | 23521W1S24 (ChemIDplus, GSRS) |
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Estimated US medical usage
Clavulanic acid
+
Amoxicillin
+
Clavulanate
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Safety
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Adverse Events
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36,560 adverse events reported
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