Amlexanox
MetabolicFDA ApprovedAlso known as: Aphthasol, Solfa, AA-673, CHX-3673, Amoxanox, Elics
Amlexanox is an old anti-inflammatory drug with a second life. It was approved by the FDA in 1996 as a 5 percent oral paste under the brand name Aphthasol for canker sores, and it has also been used clinically as an anti-allergic and anti-asthma medicine (PMID: 23396211).
Overview
At A Glance
Amlexanox inhibits the non-canonical IkB kinases TBK1 and IKK-epsilon. These kinases are induced in liver and adipose tissue by NF-kB activation during high-fat feeding and initiate a counter-inflammatory program that preserves energy storage and suppresses energy expenditure; in…
Overview
Amlexanox is an old anti-inflammatory drug with a second life. It was approved by the FDA in 1996 as a 5 percent oral paste under the brand name Aphthasol for canker sores, and it has also been used clinically as an anti-allergic and anti-asthma medicine (PMID: 23396211). The US paste product was later discontinued following the end of a commercial licensing agreement rather than because of a safety finding. It is a small molecule, not a peptide, and it is taken by mouth. The metabolic interest started in 2013 at the University of Michigan. Alan Saltiel and colleagues were studying two related protein kinases, TBK1 and IKK-epsilon, which are switched on in liver and fat during high-fat feeding and which appear to work as a brake on energy expenditure, keeping the body in storage mode. Screening for inhibitors turned up amlexanox, a drug already approved and already known to be tolerated in people. Treating obese mice with it raised energy expenditure through increased thermogenesis, producing weight loss, better insulin sensitivity and less fatty liver (PMID: 23396211). That is a genuinely interesting mechanism because it is neither a stimulant nor an appetite suppressant. The weight change came from the energy expenditure side, and the same laboratory later reported that amlexanox improves dyslipidemia and prevents atherosclerosis in mice (PMID: 35917178). Human testing followed, and the results are more measured than the mouse data. A randomized, double-blind, placebo-controlled trial of 42 obese patients with type 2 diabetes and non-alcoholic fatty liver disease found a statistically significant reduction in hemoglobin A1c and fructosamine on amlexanox. Only a subset of participants also improved on insulin sensitivity and hepatic steatosis, and those responders could be distinguished by an inflammatory gene expression signature in their baseline subcutaneous fat biopsy (PMID: 28683283; NCT01975935). An earlier version of the study was terminated after enrolling seven people (NCT01842282). No trial has tested amlexanox for weight loss in people without diabetes, and the published human record is one completed trial of 42 patients. The rest of the recent literature is preclinical work on TBK1 and IKK-epsilon inhibition in fatty liver disease, kidney fibrosis, psoriasis, lupus and several cancers (PMID: 40519640; PMID: 40341181; PMID: 41110750), which reflects how central these kinases are to inflammatory signaling rather than any established human benefit in those conditions. Capsules sold for metabolic use are an approved topical drug repackaged for a systemic indication that has been tested once, in 42 people, for twelve weeks.
Potential Research Fields
Chemical Information
IUPAC Name
Not yet available
CAS Number
68302-57-8
Molecular Formula
C16H14N2O4
Molecular Mass
298.29 g/mol
Dosing & Protocols
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Interactions
Contraindications
Label-based for the approved topical paste, which carries its own prescribing information. For oral systemic use, no contraindications have been established because only one completed trial exists (PMID: 28683283). Mechanism-based caution applies: TBK1 and IKK-epsilon are central to antiviral interferon signaling, and amlexanox inhibits type I interferon production and B cell differentiation in laboratory studies (PMID: 40341181), so immune consequences of sustained inhibition are unquantified in humans. No pregnancy, lactation or pediatric data exist for systemic use.
Research Disclaimer
This interaction data is compiled from published research and community reports. It may not be exhaustive. Always consult a healthcare professional before combining compounds.
$79.99
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1
1
capsule
| Vendor | Product | Form | Qty | Price | $/mg | Coupon | |
|---|---|---|---|---|---|---|---|
 |
Amlexanox capsules (60) | capsule | 60 capsules● In Stock | $79.99BEST | — | — |
Tracking since Sep 7, 2026 · 1 data point
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Related Compounds
View AllAICAR (acadesine)
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Cardarine (GW501516)
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Metformin
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SLU-PP-915
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Protocols, calculator & safety for Amlexanox
Research Score
0 PubMed studies
Quality Indicators
Data Completeness
63%Quick Facts
Half-Life
Not established in published human pharmacokinetic studies for the oral capsule form; a validated plasma assay has been used for preclinical pharmacokinetics in rats (PMID: 34842293)
Molecular Weight
298.29 g/mol
Administration
Oral, Topical oral paste
CAS Number
68302-57-8
Trial Phase
FDA Approved
Research Disclaimer
This information is for educational and research purposes only. Not intended as medical advice. Consult a healthcare professional before use.
Frequently Asked Questions
What is Amlexanox used for in research?
Amlexanox is an old anti-inflammatory drug with a second life. It was approved by the FDA in 1996 as a 5 percent oral paste under the brand name Aphthasol for canker sores, and it has also been used clinically as an anti-allergic and anti-asthma medicine (PMID: 23396211). The US paste product was later discontinued following the end of a commercial licensing agreement rather than because of a safety finding. It is a small molecule, not a peptide, and it is taken by mouth.
The metabolic interest started in 2013 at the University of Michigan. Alan Saltiel and colleagues were studying two related protein kinases, TBK1 and IKK-epsilon, which are switched on in liver and fat during high-fat feeding and which appear to work as a brake on energy expenditure, keeping the body in storage mode. Screening for inhibitors turned up amlexanox, a drug already approved and already known to be tolerated in people. Treating obese mice with it raised energy expenditure through increased thermogenesis, producing weight loss, better insulin sensitivity and less fatty liver (PMID: 23396211).
That is a genuinely interesting mechanism because it is neither a stimulant nor an appetite suppressant. The weight change came from the energy expenditure side, and the same laboratory later reported that amlexanox improves dyslipidemia and prevents atherosclerosis in mice (PMID: 35917178).
Human testing followed, and the results are more measured than the mouse data. A randomized, double-blind, placebo-controlled trial of 42 obese patients with type 2 diabetes and non-alcoholic fatty liver disease found a statistically significant reduction in hemoglobin A1c and fructosamine on amlexanox. Only a subset of participants also improved on insulin sensitivity and hepatic steatosis, and those responders could be distinguished by an inflammatory gene expression signature in their baseline subcutaneous fat biopsy (PMID: 28683283; NCT01975935). An earlier version of the study was terminated after enrolling seven people (NCT01842282). No trial has tested amlexanox for weight loss in people without diabetes, and the published human record is one completed trial of 42 patients.
The rest of the recent literature is preclinical work on TBK1 and IKK-epsilon inhibition in fatty liver disease, kidney fibrosis, psoriasis, lupus and several cancers (PMID: 40519640; PMID: 40341181; PMID: 41110750), which reflects how central these kinases are to inflammatory signaling rather than any established human benefit in those conditions.
Capsules sold for metabolic use are an approved topical drug repackaged for a systemic indication that has been tested once, in 42 people, for twelve weeks.
What forms does Amlexanox come in?
Amlexanox is available in capsule form.
How much does Amlexanox cost?
Prices start at $79.99 across 1 verified vendor.
How do I compare Amlexanox vendors?
Compare prices, payment methods, shipping, and COA scores across 1 vendor.
Research Tools
Related Compounds
View AllAICAR (acadesine)
MetabolicPhase 3AICAR is a nucleoside analog of adenosine.
Berberine
MetabolicPreclinicalBerberine is an isoquinoline alkaloid — a naturally occurring plant secondary metabolite with a characteristic yellow color — extracted from the roots, rhizomes, stems, and bark of several plant genera including Berberis (barberry, Oregon grape), Coptis (goldthread), Hydrastis (goldenseal), Phellodendron (Amur cork tree), and Tinospora (guduchi).
Cardarine (GW501516)
MetabolicDiscontinuedCardarine is the market name for GW501516, a synthetic agonist of the nuclear receptor PPAR-delta developed by GlaxoSmithKline as a treatment for low HDL cholesterol and the lipid problems that travel with metabolic syndrome.
Metformin
MetabolicPreclinicalMetformin is a biguanide-class oral antihyperglycemic medication that has been in continuous clinical use since 1957 (in France under the brand name Glucophage) and is now the most-prescribed diabetes medication worldwide with over 150 million prescriptions annually.
SLU-PP-915
MetabolicPreclinicalSLU-PP-915 is an experimental agonist of the estrogen-related receptors, a family of three orphan nuclear receptors called ERR-alpha, ERR-beta and ERR-gamma that control genes for mitochondrial biogenesis, oxidative phosphorylation, fatty acid oxidation and the Krebs cycle.
Sobetirome (GC-1)
MetabolicDiscontinuedSobetirome, also called GC-1 and later QRX-431, is a synthetic analog of thyroid hormone made in Thomas Scanlan laboratory and first described in 1998 as a high-affinity, subtype-selective agonist for the thyroid hormone receptor (PMID: 9653548).
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