Amlexanox Research Reference

Catalog classification, reference sizes, lab math links, and source-backed data. Educational use only — not medical advice.

Researched for: inflammatory kinase and metabolic signaling

Metabolic Research compound PowderTabletOral paste verified

Also known as: AA-673, CHX-3673

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Quick Facts

Reference Sizes

50 mg tablets, 5% oral paste, 1 g powder

Storage

Store according to the approved product label or supplier COA; bulk research-powder stability is supplier-specific

Solubility

Poorly water-soluble; formulation-dependent

Catalog Description

Amlexanox inhibits the inflammatory kinases TBK1 and IKK-epsilon. In the United States, FDA approval was for a 5% oral paste for aphthous ulcers; 50 mg tablets are approved in Japan, but not the United States, for asthma. A randomized double-blind placebo-controlled proof-of-concept study enrolled 42 adults with obesity, type 2 diabetes, and nonalcoholic fatty liver disease and used 50 mg orally three times daily for 12 weeks. The study reported statistically significant changes in HbA1c and fructosamine, with additional metabolic changes concentrated in a responder subset. This research did not establish an FDA-approved systemic metabolic indication.

Catalog descriptions reflect research context only. Not a medical claim or treatment recommendation.

Research Profile

Half-Life

~3.5 hours (per approved-indication labeling)

Onset

Metabolic outcomes assessed over the trial duration (weeks) in the proof-of-concept RCT

Administration Routes (Research)

Oral

Reported Research Effects

Inhibits TBK1/IKK-epsilon kinases (elevated in obesity)
Increases thermogenesis and energy expenditure in obese mice
RCT: significant HbA1c/fructosamine reduction in a 42-patient T2D/NAFLD trial (responder-subset effect)
Improves dyslipidemia and prevents atherosclerosis in preclinical models

Reported Research Side Effects

Systemic metabolic use remains investigational in the United States
The 42-person trial was small and responder-subset findings require replication
Approved-product safety information does not establish safety for unapproved combination protocols

Data source: Proof-of-concept RCT (Cell Metabolism); preclinical mouse studies (PubMed)

Reflects preclinical/research literature context only. Not a medical claim, dosing instruction, or treatment recommendation.

Research Protocols Reported in the Literature

50 mg three times daily [Oral; 12 weeks; Three divided doses daily]Source: randomized placebo-controlled metabolic study PMC5663294

Research Notes

The earlier rimonabant, tesofensine, semaglutide, and anticoagulant entries were not supported by established interaction or combination studies and were removed. Any real medication-interaction decision needs product labeling and clinician or pharmacist review.

Supplementary research context only. Not medical advice or a treatment recommendation.

Sources

Inhibition of IKK-epsilon and TBK1 improves glucose control in a subset of patients with type 2 diabetes — PubMed Central (NIH)
https://pmc.ncbi.nlm.nih.gov/articles/PMC5663294/

FDA approval package describing U.S. oral-paste approval and Japanese tablet approval — U.S. Food and Drug Administration
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021727s000_OraDiscA_Statr.pdf

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Research Use Only. All content is for educational and research reference only. Not medical advice, a treatment recommendation, or guidance on human use. Compounds are not FDA-approved drugs unless specifically noted.