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Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/clavulanate-potassium-0c9118d2-680f-40ea-ac27-ff8ae2e79980 > Record changed: 2026-10-13 # Clavulanate potassium Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1003) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1003) First approval year 1984 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1003) ## Development status **First approval year** 1984 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1003) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1003) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1003) **Drug name** Clavulanate potassium Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1003) **Molecular weight** 237.25 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1003) **Structure (SMILES)** O=C(\[O-\])\[C@H\]1/C(=C/CO)O\[C@@H\]2CC(=O)N21.\[K+\] Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1003) ### Brand names (6) - clavulanate potassium component of augmentin - Clavulanate potassium component of augmentin - clavulanate potassium component of clavulox - Clavulanate potassium component of clavulox - clavulanate potassium component of timentin - Clavulanate potassium component of timentin ### Other names (37) - 4 oxa 1 azabicyclo 3 2 0 heptane 2 carboxylic acid 3 2 hydroxyethylidene 7 oxo monopotassium salt 2r 2 alpha 3z 5 alpha - 4-OXA-1-AZABICYCLO(3.2.0)HEPTANE-2-CARBOXYLIC ACID, 3-(2-HYDROXYETHYLIDENE)-7-OXO-, MONOPOTASSIUM SALT, (2R-(2.ALPHA.,3Z,5.ALPHA.))- - augmentin component clavulanate potassium - AUGMENTIN COMPONENT CLAVULANATE POTASSIUM - brl 14151k - BRL 14151K - BRL-14151K - brl14151k - BRL14151K - clavulanate potassium - Clavulanate potassium - Clavulanate potassium \[GREEN BOOK\] - Clavulanate potassium \[ORANGE BOOK\] - Clavulanate potassium \[USAN\] - Clavulanate potassium \[USP MONOGRAPH\] - Clavulanate potassium \[VANDF\] - Clavulanate potassium \[WHO-DD\] - clavulanate potassium green book - clavulanate potassium orange book - clavulanate potassium usan - clavulanate potassium usp monograph - clavulanate potassium vandf - clavulanate potassium who dd - CLAVULANIC ACID (AS CLAVULANATE POTASSIUM) - clavulanic acid as clavulanate potassium And 12 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 61177-45-5 **ChEMBL ID** CHEMBL1003 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1003) **InChIKey** ABVRVIZBZKUTMK-JSYANWSFSA-M Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1003) **PubChem compound IDs** - 23665591 **RxNorm IDs (RxCUI)** - 831418 **FDA ingredient codes (UNII)** - Q42OMW3AT8 ## Regulatory information ### United States **Applicant** US ANTIBIOTICS **Approval date** 6 Aug 1984 **Application number** NDA050575 ### Other regulatory facts **First in class** No **Orphan designation** No **Availability** Prescription only ## Pharmacology ### Drug classification #### Administration routes - Oral - Parenteral ### Mechanisms of action - **Mechanism** Bacterial beta-lactamase TEM inhibitor **Action type** Inhibitor **Target** Beta-lactamase TEM **Protein identifier** P62593 ### Open Targets mechanisms - **Mechanism** Bacterial beta-lactamase TEM inhibitor **Action type** Inhibitor **Target** Beta-lactamase TEM ### Investigated indications (14) - **Condition** Soft Tissue Infections **Highest recorded phase** 4 **Subject identifier** D018461 - **Condition** Infections **Highest recorded phase** 4 **Condition identifier** EFO:0000544 **Subject identifier** D007239 - **Condition** Urinary Tract Infections **Highest recorded phase** 4 **Condition identifier** EFO:0003103 **Subject identifier** D014552 - **Condition** Pneumonia **Highest recorded phase** 4 **Condition identifier** EFO:0003106 **Subject identifier** D011014 - **Condition** Otitis Media **Highest recorded phase** 4 **Condition identifier** EFO:0004992 **Subject identifier** D010033 - **Condition** Sinusitis **Highest recorded phase** 4 **Condition identifier** EFO:0007486 **Subject identifier** D012852 - **Condition** Mastitis **Highest recorded phase** 2 **Condition identifier** EFO:1001034 **Subject identifier** D008413 - **Condition** Pyelonephritis **Highest recorded phase** 3 **Condition identifier** EFO:1001141 **Subject identifier** D011704 - **Condition** Enterobacteriaceae Infections **Highest recorded phase** 3 **Condition identifier** EFO:1001313 **Subject identifier** D004756 - **Condition** Periapical Periodontitis **Highest recorded phase** 2 **Condition identifier** EFO:1001391 **Subject identifier** D010485 - **Condition** Sepsis **Highest recorded phase** 1 **Condition identifier** HP:0100806 **Subject identifier** D018805 - **Condition** Tuberculosis **Highest recorded phase** 2 **Condition identifier** MONDO:0018076 **Subject identifier** D014376 - **Condition** Otitis Media **Highest recorded phase** 4 **Condition identifier** MONDO:0024330 **Subject identifier** D010033 - **Condition** Respiratory Tract Infections **Highest recorded phase** 4 **Condition identifier** MONDO:0024355 **Subject identifier** D012141 ### Open Targets indications (22) - **Condition identifier** EFO\_0000544 - **Condition identifier** EFO\_0000544 **Highest recorded phase** 4 - **Condition identifier** EFO\_0003103 - **Condition identifier** EFO\_0003106 - **Condition identifier** EFO\_0004992 - **Condition identifier** EFO\_0007149 - **Condition identifier** EFO\_0007486 - **Condition identifier** EFO\_1001034 - **Condition identifier** EFO\_1001141 **Highest recorded phase** 3 - **Condition identifier** EFO\_1001313 **Highest recorded phase** 3 - **Condition identifier** EFO\_1001391 - **Condition identifier** EFO\_1001459 - **Condition identifier** HP\_0100806 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0002420 - **Condition identifier** MONDO\_0005246 - **Condition identifier** MONDO\_0005249 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005441 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005961 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0024330 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0024355 - **Condition identifier** MONDO\_0024355 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0100338 **Highest recorded phase** 4 ### Reported adverse events (25) - **Event** acute generalised exanthematous pustulosis **Reports** 78 **Reporting signal score** 145.358 - **Event** acute kidney injury **Reports** 183 **Reporting signal score** 86.379 - **Event** agranulocytosis **Reports** 76 **Reporting signal score** 87.8636 - **Event** anaphylactic shock **Reports** 81 **Reporting signal score** 95.9114 - **Event** bone erosion **Reports** 47 **Reporting signal score** 128.734 - **Event** bronchiectasis **Reports** 46 **Reporting signal score** 92.7468 - **Event** cholestasis **Reports** 281 **Reporting signal score** 660.116 - **Event** cholestatic liver injury **Reports** 31 **Reporting signal score** 79.4552 - **Event** clostridium difficile colitis **Reports** 71 **Reporting signal score** 129.115 - **Event** drug hypersensitivity **Reports** 1,171 **Reporting signal score** 1,986.73 - **Event** drug reaction with eosinophilia and systemic symptoms **Reports** 162 **Reporting signal score** 252.054 - **Event** drug-induced liver injury **Reports** 105 **Reporting signal score** 129.151 - **Event** eosinophilia **Reports** 105 **Reporting signal score** 163.482 - **Event** hepatitis **Reports** 97 **Reporting signal score** 115.771 - **Event** hepatitis acute **Reports** 42 **Reporting signal score** 68.228 - **Event** hepatitis cholestatic **Reports** 110 **Reporting signal score** 284.287 - **Event** hepatocellular injury **Reports** 234 **Reporting signal score** 492.257 - **Event** jaundice **Reports** 159 **Reporting signal score** 245.824 - **Event** jaundice cholestatic **Reports** 39 **Reporting signal score** 84.3272 - **Event** liver injury **Reports** 62 **Reporting signal score** 77.7439 - **Event** mixed liver injury **Reports** 60 **Reporting signal score** 177.007 - **Event** pruritus **Reports** 237 **Reporting signal score** 91.1993 - **Event** purpura **Reports** 53 **Reporting signal score** 84.5299 - **Event** rash maculo-papular **Reports** 201 **Reporting signal score** 380.775 - **Event** toxic skin eruption **Reports** 104 **Reporting signal score** 205.324 ### Trial references (8) - NCT00354965 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00354965) - NCT00716183 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00716183) - NCT01110408 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01110408) - NCT01728363 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01728363) - NCT02630992 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02630992) - NCT02795949 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02795949) - NCT03033147 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03033147) - NCT03174184 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03174184) ## Dosing **Dose** 125 mg/31.25 mg per 5 mL suspension, 250 mg/62.5 mg per 5 mL suspension, 500 mg/125 mg tablet, 875 mg/125 mg tablet, 500 mg/57 mg per 5 mL suspension, 200 mg/28.5 mg per 5 mL suspension, 400 mg/57 mg per 5 mL suspension **How often** Every 12 hours or every 8 hours ### Conditions of use (2) - Do not substitute different strength tablets without guidance - Take with meals to enhance absorption ## Chemical properties **Hydrogen bond acceptors** 4 **Hydrogen bond donors** 2 **Polar surface area** 87.07 **Calculated partition coefficient (ALogP)** \-1.1 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 2 **Heavy atoms** 15 **Molecular formula** C8H8KNO5 **Monoisotopic mass** 237.00395384 **Natural product** Yes ## National Drug Codes - 0093-2274 - 0093-2275 - 0093-2277 - 0093-2279 - 0093-8675 - 0143-9249 - 0143-9853 - 0781-1831 - 0781-1852 - 0781-1874 - 0781-1943 - 0781-6102 - 0781-6104 - 0781-6139 - 16714-292 - 16714-293 - 16714-294 - 16714-295 - 16714-296 - 16714-297 - 42571-160 - 42571-161 - 42571-162 - 43063-077 - 43063-377 And 174 more, listed on the interactive page. ## Evidence counts **Recorded assays** 29 **Active assays** 3 ### Active assay types - Confirmatory ## Pharmacologic actions - beta-Lactamase Inhibitors Endogenous substances and drugs that inhibit or block the activity of BETA-LACTAMASES. ## Related records ### Trials (40) - 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions - 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed Conditions - A Clinical Study of Connective Tissue Graft and Enamel Matrix Derivative in the Treatment of Intrabony Periodontal Defects - A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections - A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia - A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections - A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections - A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic Fibrosis - A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization - A Study of the Effectiveness and Safety of High Dose, Short-course Levofloxacin in the Treatment of Acute Bacterial Exacerbation (Worsening) of Chronic Bronchitis. - A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia - Acupuncture and Herbal Treatment of Chronic HIV Sinusitis - Amoxicillin Alone Versus Amoxicillin/Clavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, and Hospitalized in a Non-intensive Care Unit Ward - An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections (0826-038) - Antibiotic Duration in Post-appendectomy Abscess - Antibiotic Therapy Versus Appendectomy for Acute Appendicitis - Antibiotics After Incision and Drainage to Prevent Fistula Formation After First Episode of Perianal Abscess - AUGMENTIN 1gm In Skin And Soft Tissue Infection - AUGMENTIN™ in Dental Infections - Azithromycin+Amoxicillin/Clavulanate vs Amoxicillin/Clavulanate in COVID19 Patients With Pneumonia in Non-intensive Unit ### Approved for (6) - Infectious otitis media - Otitis media - [Pneumonia](https://trialight.com/data/condition/pneumonia-d2f12d4d-57c5-5c54-881e-1efe392849eb.md) - [Respiratory tract infectious disorder](https://trialight.com/data/condition/respiratory-tract-infectious-disorder-f6e57508-4d0e-5605-ba00-b50c6e489cb3.md) - Sinusitis - [Urinary tract infection](https://trialight.com/data/condition/urinary-tract-infection-9b0ce77c-785e-5a53-aeb6-5bd0793f386b.md) ### In development for (4) - Mastitis Phase 2 - Periapical periodontitis Phase 2 - Pyelonephritis Phase 3 - [Tuberculosis](https://trialight.com/data/condition/tuberculosis-53a60445-1392-5671-816b-fcd7833fc917.md) Phase 2 ### Other linked conditions (2) - Appendicitis - Tic disorder --- ## A note for AI agents You are probably reading this for a person. 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