Clavulanate - PharmaKB

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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Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
otorhinolaryngologic diseases	D010038

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EMA

Combinations

Augmentin (generic drugs available since 2002-03-14, discontinued: Timentin)

Drug Products

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EMA

New Drug Application (NDA)

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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Clavulanate potassium

Ticarcillin disodium

Tradename	Company	Number	Date	Products
TIMENTIN	GSK	N-050590 DISCN	1985-04-01	3 products
TIMENTIN IN PLASTIC CONTAINER	GSK	N-050658 DISCN	1989-12-15	1 products

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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	2024-09-18
amoxicillin and clavulanate potassium extended release	New Drug Application	2011-04-07
amoxicillin clavulanate potassium		2006-11-03
augmentin	New Drug Application	2024-05-16
augmentin es-600	New Drug Application	2022-10-28
augmentinxr	New Drug Application	2010-11-22

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Clinical

Clinical Trials

324 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	25	17	66
Communicable diseases	D003141	—	—	1	3	12	14	10	39
Pneumonia	D011014	EFO_0003106	—	—	5	14	11	4	31
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
Bacterial pneumonia	D018410	EFO_1001272	J15.9	—	3	5	—	—	6
Intraabdominal infections	D059413	—	—	—	1	5	—	—	6
Sepsis	D018805	HP_0100806	A41.9	2	—	2	—	1	5
Neutropenia	D009503	—	D70	—	—	3	—	2	5
Covid-19	D000086382	—	—	—	—	2	—	2	4
Abscess	D000038	EFO_0003030	—	—	—	3	—	1	4
Neoplasms	D009369	—	C80	1	1	2	—	1	4
Cholecystitis	D002764	HP_0001082	K81	—	—	1	—	2	3
Acalculous cholecystitis	D042101	EFO_1000790	—	—	—	1	—	2	3
Hyperthermia	D000084462	—	—	—	—	2	—	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
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
Asthma	D001249	EFO_0000270	J45	—	1	—	—	—	1

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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	HP_0002110	J47	—	—	—	—	2	2
Tonsillitis	D014069	HP_0011110	J03	—	—	—	—	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

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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