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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Therapeutic Areas
Trade Name
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EMA
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Drug Products
FDA
EMA
Labels
FDA
EMA
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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
No data
Patent Expiration
No data
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
No data
Clinical
Clinical Trials
79 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | 8 | 1 | — | — | 10 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | — | 1 | — | — | 2 |
| Multiple myeloma | D009101 | C90.0 | — | — | 1 | — | — | 1 | |
| Peripheral nervous system diseases | D010523 | G64 | — | — | 1 | — | — | 1 | |
| Trophoblastic neoplasms | D014328 | — | — | 1 | — | — | 1 | ||
| Trigeminal neuralgia | D014277 | EFO_1001219 | G50.0 | — | — | 1 | — | — | 1 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | 1 | ||
| Hepatoblastoma | D018197 | C22.2 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | D46 | 2 | 8 | — | — | — | 9 | |
| Leukemia | D007938 | C95 | 6 | 6 | — | — | — | 9 | |
| Sarcoma | D012509 | 2 | 4 | — | — | — | 5 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 4 | — | — | — | 5 |
| Central nervous system neoplasms | D016543 | 1 | 2 | — | — | — | 3 | ||
| Mucositis | D052016 | EFO_1001898 | — | 3 | — | — | — | 3 | |
| Prostatic neoplasms | D011471 | C61 | — | 3 | — | — | — | 3 | |
| Uterine cervical neoplasms | D002583 | 2 | 2 | — | — | — | 3 | ||
| Colorectal neoplasms | D015179 | 1 | 2 | — | — | — | 2 | ||
| Neutropenia | D009503 | D70 | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasma cell neoplasms | D054219 | 2 | — | — | — | — | 2 | ||
| Renal cell carcinoma | D002292 | 1 | — | — | — | — | 1 | ||
| Melanoma | D008545 | 1 | — | — | — | — | 1 | ||
| Retinoblastoma | D012175 | 1 | — | — | — | — | 1 | ||
| Chordoma | D002817 | EFO_0000334 | 1 | — | — | — | — | 1 | |
| Malignant mesothelioma | D000086002 | 1 | — | — | — | — | 1 | ||
| Fanconi anemia | D005199 | Orphanet_84 | D61.09 | 1 | — | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | D47.1 | 1 | — | — | — | — | 1 | |
| Precancerous conditions | D011230 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
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 | 46307 |
| ChEMBL ID | CHEMBL1096 |
| ChEBI ID | 31205 |
| PubChem CID | 2161 |
| DrugBank | DB01025 |
| UNII ID | BRL1C2459K (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
TBK1
TBK1
IKBKE
IKBKE
Variants
Clinical Variant
No data
Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 675 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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750 adverse events reported
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