AMLEXANOX
Aphthasol (amlexanox) is a small molecule pharmaceutical. Amlexanox was first approved as Aphthasol on 1996-12-17. It is used to treat atopic dermatitis, rhinitis, and ulcer in the USA. It is known to target serine/threonine-protein kinase TBK1 and inhibitor of nuclear factor kappa-B kinase subunit epsilon.
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Commercial
Therapeutic Areas
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Drug Products
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| atopic dermatitis | EFO_0000274 | D003876 | L20 |
| rhinitis | EFO_0008521 | D012220 | J31 |
| ulcer | MPATH_579 | D014456 | — |
Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AD: Other agents for local oral treatment in atc
— A01AD07: Amlexanox
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03D: Other systemic drugs for obstructive airway diseases in atc
— R03DX: Other systemic drugs for obstructive airway diseases in atc
— R03DX01: Amlexanox
HCPCS
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Clinical
Clinical Trials
5 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 2 | — | — | — | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 2 | — | — | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | — | — | — | 2 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 2 | — | — | — | 2 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 2 | — | — | — | 2 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 2 | — | — | — | 2 |
| Head and neck neoplasms | D006258 | — | — | — | 1 | — | — | — | 1 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | — | 1 | — | — | — | 1 |
| Mucositis | D052016 | EFO_1001898 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary bladder calculi | D001744 | EFO_1000839 | N21.0 | — | — | — | — | 1 | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | AMLEXANOX |
| INN | amlexanox |
| Description | Amlexanox is a pyridochromene-derived monocarboxylic acid having an amino substituent at the 2-position, an oxo substituent at the 5-position and an isopropyl substituent at the 7-position. It has a role as an anti-allergic agent, an anti-ulcer drug and a non-steroidal anti-inflammatory drug. It is a pyridochromene and a monocarboxylic acid. |
| Classification | Small molecule |
| Drug class | antiallergic respiratory tract drugs (xanoxic acid derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)c1ccc2oc3nc(N)c(C(=O)O)cc3c(=O)c2c1 |
Identifiers
| PDB | — |
| CAS-ID | 68302-57-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1096 |
| ChEBI ID | 31205 |
| PubChem CID | 2161 |
| DrugBank | DB01025 |
| UNII ID | BRL1C2459K (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
TBK1
TBK1
IKBKE
IKBKE
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Amlexanox
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Trends
PubMed Central
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Additional graphs summarizing 898 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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18 adverse events reported
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