Amlexanox

• Decreased fat mass
• Improved insulin sensitivity and blood glucose regulation
• Decreased systemic inflammation
• Increased energy expenditure

Potential side effects

Rash, itching or stinging of the skin

Inflammation of the lining of the mouth

Nausea

Diarrhea

WARNINGS

Amlexanox should be avoided in patients with compromised immune systems, such as those with chronic conditions like cancer or HIV, or those undergoing immunosuppressive therapy

Amlexanox works by inhibiting protein kinases IKKε and TBK1 in the liver. An immediate effect is reduced food intake. However, a more durable effect is the production of the hormone Fibroblast Growth Factor 21 (FGF21), responsible for increased energy expenditure. In both animals and humans, this results in improvements to insulin sensitivity and inflammation, and decreases in blood glucose, fatty liver, and weight. 

IMPORTANT INFORMATION ABOUT COMPOUNDED MEDICATIONS

This medication has been compounded (custom-prepared) by a pharmacy. Compounded medications are specially prepared for individual patient needs based on a valid prescription from a prescribing healthcare practitioner and, as such, are not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. Compounded drugs are intended for patients whose prescriber has determined their medical needs are not met by an available FDA-approved drug. These statements have not been evaluated by the FDA.

This compounded preparation:

• Has not been approved by the FDA
• Has not undergone FDA review for safety, effectiveness, or quality
• Is prepared specifically for you based on your prescriber's order
• Individual outcomes may vary

Dosing is determined by the prescribing provider based on patient-specific factors. Always follow your healthcare provider's instructions. Compounded medications are not subject to FDA approval and lack the same safety and efficacy data as FDA-approved commercial medications. This medication should be prescribed and monitored by a licensed healthcare professional familiar with the condition being addressed and the specific applications of the medication.

1. Oral EA, Reilly SM, Gomez AV, Meral R, Butz L, Ajluni N, Chenevert TL, Korytnaya E, Neidert AH, Hench R, Rus D, Horowitz JF, Poirier B, Zhao  P, Lehmann K, Jain M, Yu R, Liddle C, Ahmadian M, Downes M, Evans RM, Saltiel AR. Inhibition of IKKɛ and TBK1 Improves Glucose Control in  a Subset of Patients with Type 2 Diabetes. Cell Metab. 2017 Jul 5;26(1):157-170.e7. doi: 10.1016/j.cmet.2017.06.006. PMID: 28683283; PMCID:  PMC5663294. 

2 . Reilly SM, Chiang SH, Decker SJ, Chang L, Uhm M, Larsen MJ, Rubin JR, Mowers J, White NM, Hochberg I, Downes M, Yu RT, Liddle C, Evans RM,  Oh D, Li P, Olefsky JM, Saltiel AR. An inhibitor of the protein kinases TBK1 and IKK-ɛ improves obesity-related metabolic dysfunctions in mice.  Nat Med. 2013 Mar;19(3):313-21. doi: 10.1038/nm.3082. Epub 2013 Feb 10. PMID: 23396211; PMCID: PMC3594079. 

Q. How well does it work?

A. Approximately one in three overweight individuals who try amlexanox may respond. Responders typically present with signs of systemic inflammation, oxidative stress, and features of metabolic syndrome. Ideal candidates may include obese patients with poor glycemic control, elevated visceral fat, and increased C-reactive protein (CRP) levels. Combining amlexanox with low-dose naltrexone (LDN) may offer additional synergistic benefits by further addressing inflammation and immune modulation.