Clavulanic acid
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
Trade Name
FDA
EMA
Combinations
Augmentin (generic drugs available since 2002-03-14, discontinued: 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 '875' | USAntibiotics | N-050720 RX | 1996-02-13 | 1 products, RLD |
AUGMENTIN ES-600 | USAntibiotics | N-050755 RX | 2001-06-22 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
augmentin | New Drug Application | 2023-03-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
haemophilus infections | EFO_1001127 | D006192 | — |
otitis media | EFO_0004992 | D010033 | H66.9 |
staphylococcal infections | — | D013203 | A49.01 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
514 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Major depressive disorder | D003865 | EFO_0003761 | F22 | 11 | 24 | 30 | 51 | 20 | 129 |
Depression | D003863 | F33.9 | 5 | 16 | 19 | 50 | 35 | 117 | |
Healthy volunteers/patients | — | 24 | — | — | 4 | 4 | 32 | ||
Anxiety disorders | D001008 | EFO_0006788 | F41.1 | 3 | 2 | 6 | 8 | 4 | 22 |
Depressive disorder | D003866 | EFO_1002014 | F32.A | 4 | 1 | 6 | 2 | 3 | 15 |
Anxiety | D001007 | EFO_0005230 | F41.1 | — | 1 | 3 | 5 | 6 | 14 |
Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 2 | 8 | 1 | 11 |
Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | 1 | 3 | 4 | 2 | 10 |
Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | 2 | 3 | 2 | 2 | 9 |
Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | — | 1 | 6 | 1 | 8 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Treatment-resistant depressive disorder | D061218 | 1 | — | 7 | — | 1 | 9 | ||
Neoplasms | D009369 | C80 | 1 | 1 | 4 | — | 1 | 7 | |
Cocaine-related disorders | D019970 | F14 | 1 | 5 | 1 | — | — | 6 | |
Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | 1 | 1 | — | 2 | 4 |
Parkinson disease | D010300 | EFO_0002508 | G20 | — | 2 | 2 | — | 1 | 4 |
Hot flashes | D019584 | — | — | 1 | — | 3 | 4 | ||
Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | 1 | — | 1 | 3 |
Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 1 | 1 | — | — | 2 |
Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 2 | — | — | 2 |
Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Menopause | D008593 | EFO_0003922 | N95 | — | 1 | — | — | 1 | 2 |
Ischemic stroke | D000083242 | 1 | 2 | — | — | — | 2 | ||
Male infertility | D007248 | EFO_0004248 | N46 | — | 1 | — | — | — | 1 |
Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | 1 | — | — | — | 1 |
Aphasia | D001037 | HP_0002381 | R47.01 | — | 1 | — | — | — | 1 |
Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | 1 | |
Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 1 | — | — | — | 1 |
Bereavement | D001601 | — | 1 | — | — | — | 1 | ||
Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 1 | — | — | — | 1 |
Neurodevelopmental disorders | D065886 | F89 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
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Spinal cord injuries | D013119 | EFO_1001919 | 2 | — | — | — | 1 | 3 | |
Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | 1 | 2 |
Autism spectrum disorder | D000067877 | F84.0 | 1 | — | — | — | 1 | 2 | |
Stress urinary incontinence | D014550 | HP_0010992 | 1 | — | — | — | — | 1 | |
Fecal incontinence | D005242 | R15 | 1 | — | — | — | — | 1 | |
Hepacivirus | D016174 | 1 | — | — | — | — | 1 | ||
Premature ejaculation | D061686 | HP_0012876 | F52.4 | 1 | — | — | — | — | 1 |
Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | 1 | — | — | — | — | 1 |
Hypercapnia | D006935 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 4 | 4 |
Pharmacokinetics | D010599 | — | — | — | — | 2 | 2 | ||
Cognition | D003071 | EFO_0003925 | — | — | — | — | 2 | 2 | |
Perimenopause | D047648 | — | — | — | — | 1 | 1 | ||
Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
Wounds and injuries | D014947 | T14.8 | — | — | — | — | 1 | 1 | |
Chronic disease | D002908 | — | — | — | — | 1 | 1 | ||
Brain injuries | D001930 | S06.9 | — | — | — | — | 1 | 1 | |
Alcohol-related disorders | D019973 | F10 | — | — | — | — | 1 | 1 | |
Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | — | — | — | 1 | 1 |
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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 | 21216 |
ChEMBL ID | CHEMBL777 |
ChEBI ID | 48947 |
PubChem CID | 5280980 |
DrugBank | DB00766 |
UNII ID | 23521W1S24 (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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67,928 adverse events reported
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