Investigational Drug Details
| Drug ID: | D465 |
| Drug Name: | Amlexanox |
| Synonyms: | Amlexanox; Amoxanox |
| Type: | Chemical drug |
| DrugBank ID: | DB01025 |
| DrugBank Description: | Amlexanox is an antiallergic drug, clinically effective for atopic diseases, especially allergic asthma and rhinitis. Amlexanox as a topical paste is a well tolerated treatment of recurrent aphthous ulcers. Recurrent aphthous ulcer (RAU) is the most prevalent oral mucosal disease in humans, estimated to affect between 5% and 50% of the general population. |
| PubChem ID: | -- |
| CasNo: | -- |
| Repositioning for NAFLD: | Yes |
| SMILES: | CC(C)C1=CC2=C(OC3=NC(N)=C(C=C3C2=O)C(O)=O)C=C1 |
| Structure: |
|
| InChiKey: | SGRYPYWGNKJSDL-UHFFFAOYSA-N |
| Molecular Weight: | 298.2934 |
| DrugBank Targets: | Protein S100-A12 antagonist; Protein S100-A13 antagonist; Interleukin-3 antagonist; Fibroblast growth factor 1 inhibitor |
| DrugBank MoA: | As a benzopyrano-bipyridine carboxylic acid derivative, amlexanox has anti-inflammatory and antiallergic properties. It inhibits chemical mediatory release of the slow-reacting substance of anaphylaxis (SRS-A) and may have antagonistic effects on interleukin-3. When cells are under stress, they release an inactive form of human fibroblast growth factor 1 (FGF-1), a potent mitogen (entity that causes mitosis). Amlexanox binds to FGF1, increasing its conformational stability, sterically blocking Cu(2+) induced oxidation which normally leads to activation of FGF-1. |
| DrugBank Pharmacology: | Amlexanox is a mucoadhesive oral paste which has been clinically proven to abort the onset, accelerate healing and resolve the pain of aphthous ulcers (canker sores). It decreases the time ulcers take to heal. Because amlexanox decreases the healing time, it also decreases the pain you feel. Recent studies have also shown that the majority of ulcers can be prevented by application of the paste during the prodromal (pre-ulcerative) phase of the disease. Recurrent Aphthous Ulcers (RAU) also known as Recurrent Aphthous Stomatitis (RAS) is recognized as the most common oral mucosal disease known to man. Estimates suggest that 20% - 25% of the general population suffer at least one incidence of aphthous ulcers each year. Amlexanox is also being investigated for its anti-allergenic and anti-inflammatory properties. |
| DrugBank Indication: | Used as a paste in the mouth to treat aphthous ulcers (canker sores). |
| Targets: | -- |
| Therapeutic Category: | -- |
| Clinical Trial Progress: | Phase 2 completed (NCT01975935) |
| Latest Progress: | Under clinical trials |
| Trial ID | Source ID | Phases | Status | Study Results | Start Date | Last Update Posted | |
|---|---|---|---|---|---|---|---|
| L0158 | NCT01842282 | Phase 2 | Suspended | No Results Available | July 19, 2013 | January 12, 2022 | Details |
| L0164 | NCT01975935 | Phase 2 | Completed | Has Results | January 2014 | November 7, 2018 | Details |
| Strategy ID | Strategy | Synonyms | Related Targets | Related Drugs | |
|---|---|---|---|---|---|
| S05 | Anti-inflammatory | inflammatory | Bile acid; TNF-a inhibitor; Dual PPAR-α and -δ agonists; Toll-Like Receptor; (TLR)-4 antagonist; Caspase inhibitor; ASK-1 inhibitor | Ursodeoxycholic Acid; Pentoxifylline; Elafibranor; JKB-121; Emricasan; Selonsertib; | Details |
| Article ID | PMID | Source | Title | |
|---|---|---|---|---|
| A00367 | 35115947 | Front Pharmacol | Gentiana scabra Restrains Hepatic Pro-Inflammatory Macrophages to Ameliorate Non-Alcoholic Fatty Liver Disease. | Details |
| A06382 | 32905826 | Toxicology | Dual TBK1/IKKε inhibitor amlexanox mitigates palmitic acid-induced hepatotoxicity and lipoapoptosis in vitro. | Details |
| A06429 | 32883523 | Biochem Biophys Res Commun | Long-term subcutaneous injection of lipopolysaccharides and high-fat diet induced non-alcoholic fatty liver disease through IKKε/ NF-κB signaling. | Details |
| A09619 | 31672578 | Life Sci | Amlexanox reversed non-alcoholic fatty liver disease through IKKε inhibition of hepatic stellate cell. | Details |
| A15849 | 28683283 | Cell Metab | Inhibition of IKKɛ and TBK1 Improves Glucose Control in a Subset of Patients with Type 2 Diabetes. | Details |
| A17704 | 27646933 | Gut | Current and upcoming pharmacotherapy for non-alcoholic fatty liver disease. | Details |
| A51120 | 35662709 | Front Pharmacol | Role of IKKε in the Metabolic Diseases: Physiology, Pathophysiology, and Pharmacology. | Details |
| A51167 | 35395857 | J Exp Clin Cancer Res | The role of TBK1 in cancer pathogenesis and anticancer immunity. | Details |